Drug loss · FDA / EMA vs PMDA · free list
Every new active substance approved in the US or EU since 2019, and every item on MHLW’s 2025 drug-loss list, that still has no Japanese approval: 274 drugs, with owner, orphan status and whether any Japanese development has started.
Updated 2026-09-27 · 274 drugs · 158 with no Japan signal · CSV below
Short answer. As of 2026-09-27 we count 274 drugs that have a marketing approval from the US FDA or the European Commission (EMA centralised procedure) but no approval in Japan: every new active substance first approved in the US or EU since January 2019, plus the 86 products on MHLW’s 2025 drug-loss list. For 158 of them we found no sign of Japanese development at all (no trial with a Japan site, no Japan deal, no MHLW request). PMDA’s own estimate puts the median drug lag for new active ingredients filed in Japan in FY2024 at 2.0 years, all of it development lag rather than review lag (PMDA, Dec 2025, p.12).
Drug lag (ドラッグ・ラグ) is the delay between a drug’s first approval abroad and its approval in Japan. Drug loss (ドラッグ・ロス) is the case where the drug is not being developed for Japan at all, so there is no approval to wait for. MHLW started using the term in 2023, when it found that a growing share of new drugs approved in the US or EU had no Japanese development programme, many of them from small and mid-size biotech companies without a Japanese partner (MHLW: ドラッグ・ロス解消に向けた取組について).
PMDA splits the lag into two parts: the development lag (median gap between the US filing and the Japanese filing, for drugs filed in Japan that fiscal year) and the review lag (difference between the median total review time in Japan and in the US). PMDA’s figures for new active ingredients, in years:
| Fiscal year of Japanese filing | Development lag | Review lag | Drug lag (sum) |
|---|---|---|---|
| FY2018 | 0.7 | 0.2 | 0.9 |
| FY2019 | 0.5 | 0.1 | 0.6 |
| FY2020 | 0.5 | 0.2 | 0.7 |
| FY2021 | 0.3 | 0.1 | 0.4 |
| FY2022 | 0.4 | 0.0 | 0.4 |
| FY2023 | 1.3 | 0.0 | 1.3 |
| FY2024 | 2.0 | 0.0 | 2.0 |
Source: PMDA, 令和7年度のこれまでの事業実績及び今後の取組について (Dec 2025), p.12 “ドラッグ・ラグの試算”, median values. PMDA attributes the FY2023–FY2024 widening to filings of drugs that had long been in a drug-loss state, not to slower review. Our own measure on this site, the median wait after first FDA approval for new active ingredients approved in Japan in FY2024–FY2026, is on the drug approvals page.
MHLW’s 2025 special study listed 86 products approved in the US or EU in 2016–2020 that were still unapproved in Japan, graded by medical need (group A/B/C) and marked where Japanese development had since started (MHLW, 令和6年度特別研究 ドラッグ・ロス品目の整理結果). Our list includes those and adds every new active substance first approved in the US or EU from 2019 onwards. We dropped 195 substances because a matching Japanese approval exists.
| Signal (strongest found) | Drugs | Share | |
|---|---|---|---|
| MHLW development request issued | 7 | 3% | |
| MHLW open call for a developer | 16 | 6% | |
| Clinical trial with a Japan site (ClinicalTrials.gov) | 86 | 31% | |
| Japan licensing / partnering deal announced | 7 | 3% | |
| No Japan development signal found | 158 | 58% |
Signal priority: Japan deal > MHLW development request > trial with a Japan site on ClinicalTrials.gov (any sponsor, any status) > MHLW open call. 35 drugs have a named Japanese sponsor or partner. A trial site in Japan does not mean a filing is planned.
| Year | Drugs | Share | |
|---|---|---|---|
| 2016 | 6 | 2% | |
| 2017 | 12 | 4% | |
| 2018 | 17 | 6% | |
| 2019 | 25 | 9% | |
| 2020 | 29 | 11% | |
| 2021 | 23 | 8% | |
| 2022 | 22 | 8% | |
| 2023 | 28 | 10% | |
| 2024 | 37 | 14% | |
| 2025 | 36 | 13% | |
| 2026 | 39 | 14% |
Earliest of the FDA approval date and the EU authorisation date. 112 drugs were first approved in 2024 or later and may simply not have reached Japan yet.
| Country | Drugs | Share | |
|---|---|---|---|
| United States | 142 | 52% | |
| France | 15 | 5% | |
| United Kingdom | 15 | 5% | |
| Switzerland | 15 | 5% | |
| Japan | 11 | 4% | |
| Germany | 9 | 3% | |
| Italy | 8 | 3% | |
| China | 7 | 3% | |
| India | 7 | 3% | |
| Ireland | 7 | 3% | |
| Denmark | 6 | 2% | |
| Canada | 6 | 2% |
Parent company of the FDA applicant or EMA marketing-authorisation holder (our curated table; check recent M&A). “Unknown” = not yet in Drugs@FDA.
| Modality | Drugs | Share | |
|---|---|---|---|
| small molecule | 156 | 57% | |
| antibody | 31 | 11% | |
| protein/enzyme | 19 | 7% | |
| cell/gene therapy | 14 | 5% | |
| peptide | 12 | 4% | |
| radiopharmaceutical | 11 | 4% | |
| vaccine | 11 | 4% | |
| oligonucleotide (ASO) | 8 | 3% | |
| antibody-drug conjugate | 4 | 1% | |
| oligonucleotide (siRNA) | 4 | 1% | |
| diagnostic agent | 4 | 1% |
Newest first approval first. Filter by signal, year or modality, or search a drug, company or indication. Indications are the FDA / EMA wording, shortened. Updated 2026-09-27.
| First approved | Drug (US brand) | Indication | Owner | Modality | US orphan | MHLW 2025 list | Japan signal | Sources |
|---|---|---|---|---|---|---|---|---|
| FDA 2026-09-25 | zilurgisertib Atebrioz | Reduce heterotopic ossification volume in fibrodysplasia ossificans progressiva | not yet in Drugs@FDA | small molecule | No | none found | FDA | |
| FDA 2026-09-25 | tavapadon Juvmo | Treat Parkinson's disease in adults | not yet in Drugs@FDA | small molecule | No | none found | FDA | |
| FDA 2026-09-23 | lirafugratinib Lyrfigtu | Treat unresectable cholangiocarcinoma with FGFR2 gene fusion | not yet in Drugs@FDA | small molecule | No | none found | FDA | |
| EMA 2026-09-21 | leriglitazone | Treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non Gadolinium… | Minoryx Therapeutics Spain | small molecule | — | none found | EMA | |
| FDA 2026-09-11 | floretyrosine F 18 Pixclara | Differentiate recurrent glioma from treatment-related change via PET | Telix Pharmaceuticals Australia | radiopharmaceutical | Yes | none found | FDA | |
| FDA 2026-09-11 | apitegromab Isembyld | Treat spinal muscular atrophy in patients on SMN2 therapy | Scholar Rock United States | antibody | Yes | none found | FDA MHLW | |
| FDA 2026-09-03 | zilganersen Zanvastro | Treat Alexander disease in pediatric and adult patients | Ionis United States | oligonucleotide (ASO) | Yes | trial in Japan | FDA CT.gov | |
| FDA 2026-08-28 | rusfertide Mimrylo | Treat erythrocytosis in polycythemia vera | Takeda Japan | peptide | Yes | trial in Japan | FDA CT.gov jRCT | |
| FDA 2026-08-27 | brepocitinib Lisraya | Treat dermatomyositis in adults | Priovant (Roivant) United States | small molecule | Yes | none found | FDA | |
| FDA 2026-08-26 | daraxonrasib Rasonque | Treat metastatic pancreatic cancer | Revolution Medicines United States | small molecule | Yes | trial in Japan | FDA CT.gov MHLW | |
| FDA 2026-08-19 | garetosmab Pasatru | Reduce heterotopic ossification in fibrodysplasia ossificans progressiva | Regeneron United States | antibody | Yes | trial in Japan | FDA CT.gov MHLW | |
| FDA 2026-08-13 | iberdomide Zenbexus | Treat multiple myeloma in combination therapy | Bristol Myers Squibb United States | small molecule | Yes | trial in Japan | FDA CT.gov | |
| FDA 2026-08-13 | florquinitau F 18 Tauklarify | Identify tau pathology in Alzheimer disease evaluation | Lantheus United States | radiopharmaceutical | No | none found | FDA | |
| FDA 2026-07-24 | centanafadine Simtriyo | Treat attention-deficit hyperactivity disorder | Otsuka Japan | small molecule | No | trial in Japan | FDA CT.gov | |
| FDA 2026-07-22 | zidesamtinib Jideytro | Treat ROS1-positive non-small cell lung cancer | Nuvalent United States | small molecule | Yes | trial in Japan | FDA CT.gov | |
| EMA 2026-07-15 | trenibotulinumtoxinE | Temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at maximum frown (glabellar lines),… | AbbVie United States | protein/enzyme | — | none found | EMA | |
| FDA 2026-07-15 | enlicitide decanoate Lipfendra | Reduce low-density lipoprotein cholesterol | Merck & Co. (MSD) United States | peptide | No | trial in Japan | FDA CT.gov jRCT | |
| FDA 2026-07-14 | gedatolisib Revtorpyk | Treat hormone receptor-positive breast cancer with fulvestrant | Celcuity United States | small molecule | No | trial in Japan | FDA CT.gov | |
| FDA 2026-07-07 | atacicept Trutakna | Reduce proteinuria in primary immunoglobulin A nephropathy | Vera Therapeutics United States | protein/enzyme | No | trial in Japan | FDA CT.gov MHLW | |
| FDA 2026-06-26 | veligrotug Lumvoa | Treat thyroid eye disease | Viridian Therapeutics United States | protein/enzyme | No | none found | FDA | |
| EMA 2026-06-19 | tolebrutinib | Treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years | Sanofi France | small molecule | — | trial in Japan | EMA CT.gov | |
| FDA 2026-05-29 | cipepofol Cypsedo | Induce general anesthesia in adults undergoing surgery | Haisco Pharmaceutical China | small molecule | No | none found | FDA | |
| FDA 2026-05-29 | cefepime and zidebactam Zaynich | Treat complicated urinary tract infections | Wockhardt India | small molecule | No | none found | FDA | |
| FDA 2026-05-27 | pivekimab sunirine Decnupaz | Treat blastic plasmacytoid dendritic cell neoplasm | AbbVie United States | antibody-drug conjugate | Yes | none found | FDA | |
| FDA 2026-05-15 | baxdrostat Baxfendy | Treat hypertension in combination with other agents | AstraZeneca United Kingdom | small molecule | No | trial in Japan | FDA CT.gov | |
| FDA 2026-05-13 | sonrotoclax Beqalzi | Treat relapsed mantle cell lymphoma | BeOne Medicines (BeiGene) Switzerland | small molecule | Yes | trial in Japan | FDA CT.gov | |
| FDA 2026-05-01 | vepdegestrant Veppanu | Treat ESR1-mutated advanced breast cancer | Rigel Pharmaceuticals United States | small molecule | No | trial in Japan | FDA CT.gov | |
| EMA 2026-04-20 | influenza mRNA vaccine / COVID-19 mRNA vaccine | Active immunisation for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and… | Moderna United States | vaccine | — | trial in Japan | EMA CT.gov | |
| FDA 2026-04-01 | orforglipron Foundayo | Reduce excess body weight in obesity | Eli Lilly United States | small molecule | No | trial in Japan | FDA CT.gov | |
| EMA 2026-03-30 | trivalent influenza vaccine (recombinant, prepared in cell culture) | Active immunisation for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek… | Sanofi France | vaccine | — | none found | EMA | |
| FDA 2026-03-25 | relacorilant Lifyorli | Treat platinum-resistant epithelial ovarian cancer | Corcept Therapeutics United States | small molecule | No | none found | FDA | |
| FDA 2026-03-24 | tividenofusp alfa Avlayah | Treat Hunter syndrome (MPS II) | Denali Therapeutics United States | protein/enzyme | Yes | none found | FDA | |
| FDA 2026-03-17 | linerixibat Lynavoy | Treat cholestatic pruritus in primary biliary cholangitis | Intercept (Alfasigma) Italy | small molecule | Yes | trial in Japan Japan partner: GlaxoSmithKline K.K. | FDA CT.gov MHLW | |
| FDA 2026-02-27 | navepegritide Yuviwel | Increase linear growth in achondroplasia | Ascendis Pharma Denmark | peptide | Yes | none found Japan partner: Teijin Pharma Limited | FDA MHLW | |
| FDA 2026-02-20 | milsaperidone Bysanti | Treat schizophrenia and bipolar I disorder | Vanda Pharmaceuticals United States | small molecule | No | none found | FDA | |
| EMA 2026-02-12 | aumolertinib | Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer… | Hansoh Pharma (EU MAH: SFL) China | small molecule | — | none found | EMA | |
| FDA 2026-01-12 | copper histidinate Zycubo | Treat Menkes disease | Sentynl Therapeutics (Zydus) United States | small molecule | Yes | none found | FDA | |
| EMA 2026-01-09 | pertussis vaccine (recombinant, acellular, component, adsorbed) | VacPertagen is indicated for: - booster immunisation against pertussis of individuals 12 years of age and older,- passive… | BioNet-Asia Thailand | vaccine | — | none found | EMA | |
| EMA 2026-01-09 | etuvetidigene autotemcel | Treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the… | Fondazione Telethon (non-profit) Italy | cell/gene therapy | — | none found | EMA | |
| FDA 2025-12-30 | tradipitant Nereus | Treat vomiting associated with motion | Vanda Pharmaceuticals United States | small molecule | No | none found | FDA | |
| FDA 2025-12-23 | narsoplimab Yartemlea | Treat hematopoietic stem cell transplant-associated thrombotic microangiopathy | Omeros United States | antibody | Yes | none found | FDA | |
| FDA 2025-12-19 EMA 2026-02-12 | aficamten Myqorzo | Treat symptomatic obstructive hypertrophic cardiomyopathy | Cytokinetics United States | small molecule | Yes | trial in Japan | FDA EMA CT.gov MHLW | |
| FDA 2025-12-12 | zoliflodacin Nuzolvence | Treat uncomplicated urogenital gonorrhea | Innoviva United States | small molecule | No | none found | FDA | |
| FDA 2025-12-12 | lerodalcibep Lerochol | Reduce low-density lipoprotein cholesterol | LIB Therapeutics United States | protein/enzyme | No | none found | FDA | |
| FDA 2025-12-12 | etripamil Cardamyst | Treat paroxysmal supraventricular tachycardia episodes | Milestone Pharmaceuticals Canada | small molecule | No | none found | FDA | |
| FDA 2025-11-25 | sibeprenlimab Voyxact | Reduce proteinuria in primary immunoglobulin A nephropathy | Otsuka Japan | antibody | No | trial in Japan | FDA CT.gov | |
| FDA 2025-11-19 | sevabertinib Hyrnuo | Treat non-small cell lung cancer with HER2 mutations | Bayer Germany | small molecule | Yes | trial in Japan | FDA CT.gov | |
| FDA 2025-11-18 EMA 2026-06-19 | plozasiran Redemplo | Reduce triglycerides in familial chylomicronemia syndrome | Arrowhead Pharmaceuticals United States | oligonucleotide (siRNA) | Yes | trial in Japan | FDA EMA CT.gov MHLW | |
| FDA 2025-11-13 | ziftomenib Komzifti | Treat relapsed or refractory acute myeloid leukemia | Kura Oncology United States | small molecule | Yes | trial in Japan Japan partner: Kyowa Kirin Co., Ltd. | FDA CT.gov jRCT MHLW | |
| FDA 2025-11-03 EMA 2026-03-26 | doxecitine and doxribtimine Kygevvi | Treat thymidine kinase 2 deficiency | UCB Belgium | small molecule | Yes | none found | FDA EMA | |
| FDA 2025-10-24 EMA 2025-11-17 | elinzanetant Lynkuet | Treat moderate-to-severe vasomotor symptoms of menopause | Bayer Germany | small molecule | No | trial in Japan | FDA EMA CT.gov | |
| FDA 2025-09-25 EMA 2026-04-23 | paltusotine Palsonify | Treat acromegaly | Crinetics United States | small molecule | Yes | Japan deal Japan partner: Sanwa Kagaku Kenkyusho | FDA EMA crinetics.com | |
| FDA 2025-09-19 | pembrolizumab and berahyaluronidase alfa Keytruda Qlex | Treat solid tumor indications approved for IV pembrolizumab | Merck & Co. (MSD) United States | antibody | No | MHLW development request IV-190: company = MSD株式会社 | MHLW request Japan partner: MSD株式会社 | FDA CT.gov jRCT MHLW |
| FDA 2025-09-19 | elamipretide Forzinity | Improve muscle strength in Barth syndrome | Stealth BioTherapeutics United States | peptide | Yes | none found | FDA | |
| EMA 2025-08-25 | allogeneic umbilical cord-derived CD34- cells, non-expanded / dorocubicel | Treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation… | Cordex Biologics United Kingdom | cell/gene therapy | — | none found | EMA | |
| FDA 2025-08-21 EMA 2026-01-19 | donidalorsen Dawnzera | Prevent hereditary angioedema attacks | Ionis United States | oligonucleotide (ASO) | Yes | none found Japan partner: Otsuka Pharmaceutical Co., Ltd. | FDA EMA MHLW | |
| FDA 2025-07-31 | aceclidine Vizz | Treat presbyopia | LENZ Therapeutics United States | small molecule | No | none found | FDA | |
| EMA 2025-07-17 | obecabtagene autoleucel | Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) | Autolus United Kingdom | cell/gene therapy | — | none found | EMA | |
| FDA 2025-07-02 | sunvozertinib Zegfrovy | Treat non-small cell lung cancer with EGFR exon 20 insertions | Dizal Pharmaceutical China | small molecule | No | trial in Japan | FDA CT.gov | |
| FDA 2025-06-09 EMA 2026-04-15 | clesrovimab Enflonsia | Prevent RSV lower respiratory tract disease in infants | Merck & Co. (MSD) United States | antibody | No | trial in Japan | FDA EMA CT.gov jRCT | |
| FDA 2025-05-28 | acoltremon Tryptyr | Treat signs and symptoms of dry eye disease | Alcon Switzerland | small molecule | No | none found | FDA | |
| FDA 2025-05-14 | telisotuzumab vedotin Emrelis | Treat non-small cell lung cancer with c-Met overexpression | AbbVie United States | antibody-drug conjugate | No | trial in Japan | FDA CT.gov | |
| FDA 2025-05-08 | avutometinib and defactinib Avmapki Fakzynja Co-Pack | Treat KRAS-mutated recurrent low-grade serous ovarian cancer | Verastem Oncology United States | small molecule | Yes | trial in Japan | FDA CT.gov | |
| FDA 2025-07-02 EMA 2025-04-23 | linvoseltamab Lynozyfic | Treat relapsed or refractory multiple myeloma | Regeneron United States | antibody | Yes | trial in Japan | FDA EMA CT.gov | |
| FDA 2025-04-23 | penpulimab penpulimab-kcqx | Treat recurrent or metastatic nasopharyngeal carcinoma | Akeso China | antibody | Yes | none found | FDA | |
| FDA 2025-04-02 | atrasentan Vanrafia | Reduce proteinuria in primary immunoglobulin A nephropathy | Novartis Switzerland | small molecule | No | trial in Japan | FDA CT.gov MHLW | |
| FDA 2025-03-28 | fitusiran Qfitlia | Prevent or reduce bleeding episodes in hemophilia | Sanofi France | oligonucleotide (siRNA) | Yes | trial in Japan | FDA CT.gov | |
| FDA 2025-03-25 | gepotidacin Blujepa | Treat uncomplicated urinary tract infections | GSK United Kingdom | small molecule | No | trial in Japan | FDA CT.gov | |
| FDA 2025-02-14 EMA 2025-09-17 | vimseltinib Romvimza | Treat symptomatic tenosynovial giant cell tumor | Ono Pharmaceutical Japan | small molecule | No | none found | FDA EMA | |
| EMA 2025-02-12 | tiratricol | Treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley… | Egetis Therapeutics Sweden | small molecule | — | none found | EMA MHLW | |
| FDA 2025-02-11 EMA 2025-07-17 | mirdametinib Gomekli | Treat neurofibromatosis type 1 plexiform neurofibromas | Merck KGaA (SpringWorks) Germany | small molecule | Yes | none found | FDA EMA | |
| EMA 2025-02-03 | serplulimab | Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‐line treatment… | Accord Healthcare (Intas) India | antibody | — | Japan deal Japan partner: Eisai | EMA eisai.com CT.gov | |
| FDA 2025-01-30 | suzetrigine Journavx | Treat moderate to severe acute pain | Vertex Pharmaceuticals United States | small molecule | No | none found | FDA | |
| EMA 2025-01-13 | vilobelimab | Treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic… | InflaRx Germany | antibody | — | none found | EMA | |
| EMA 2025-01-13 | mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10) | Diagnosis of infection with Mycobacterium tuberculosis | Serum Institute of India India | vaccine | — | none found | EMA | |
| FDA 2024-12-20 EMA 2025-06-30 | vanzacaftor, tezacaftor, and deutivacaftor Alyftrek | Treat cystic fibrosis | Vertex Pharmaceuticals United States | small molecule | Yes | none found | FDA EMA | |
| FDA 2024-12-19 EMA 2025-09-17 | olezarsen Tryngolza | Treat familial chylomicronemia syndrome | Ionis United States | oligonucleotide (ASO) | Yes | Japan deal Japan partner: Sobi (Japan rights holder, non-Japanese) | FDA EMA ir.ionis.com | |
| FDA 2024-12-18 | ensartinib Ensacove | Treat non-small cell lung cancer | Xcovery (Betta Pharma) United States | small molecule | No | none found | FDA | |
| FDA 2024-12-13 | crinecerfont Crenessity | Treat classic congenital adrenal hyperplasia | Neurocrine Biosciences United States | small molecule | Yes | none found | FDA | |
| FDA 2024-12-13 | cosibelimab Unloxcyt | Treat cutaneous squamous cell carcinoma | Sun Pharma India | antibody | No | none found | FDA | |
| FDA 2024-12-04 | zenocutuzumab Bizengri | Treat non-small cell lung cancer and pancreatic adenocarcinoma | Merus Netherlands | antibody | Yes | trial in Japan | FDA CT.gov | |
| FDA 2024-11-20 EMA 2025-06-27 | zanidatamab Ziihera | Treat HER2-positive biliary tract cancer | Jazz Pharmaceuticals Ireland | antibody | Yes | trial in Japan Japan partner: BeOne Pharmaceutical Co., Ltd. | FDA EMA CT.gov jRCT | |
| FDA 2024-11-15 | revumenib Revuforj | Treat relapsed or refractory acute leukemia | Syndax United States | small molecule | Yes | none found | FDA | |
| FDA 2024-10-25 | sulopenem etzadroxil, probenecid Orlynvah | Treat uncomplicated urinary tract infections | Iterum Therapeutics Ireland | small molecule | No | none found | FDA | |
| FDA 2024-10-10 EMA 2025-07-18 | inavolisib Itovebi | Treat locally advanced or metastatic breast cancer | Roche Switzerland | small molecule | No | trial in Japan | FDA EMA CT.gov | |
| FDA 2024-09-27 | flurpiridaz F 18 Flyrcado | PET diagnostic for myocardial ischemia and infarction | GE HealthCare United States | radiopharmaceutical | No | none found | FDA | |
| FDA 2024-09-26 | xanomeline and trospium chloride Cobenfy | Treat schizophrenia | Bristol Myers Squibb United States | small molecule | No | trial in Japan | FDA CT.gov | |
| FDA 2024-09-24 EMA 2026-01-19 | levacetylleucine Aqneursa | Treat Niemann-Pick disease type C | IntraBio United Kingdom | small molecule | Yes | none found | FDA EMA | |
| FDA 2024-09-20 | arimoclomol Miplyffa | Treat Niemann-Pick disease type C | Zevra Therapeutics United States | small molecule | Yes | none found | FDA | |
| EMA 2024-08-22 | respiratory syncytial virus mRNA vaccine | Active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in… | Moderna United States | vaccine | — | trial in Japan | EMA CT.gov | |
| EMA 2024-08-22 | polihexanide | Treatment of Acanthamoeba keratitis in adults and children from 12 years of age | SIFI Italy | small molecule | — | trial in Japan | EMA CT.gov | |
| EMA 2024-08-22 | odronextamab | Treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy | Regeneron United States | antibody | — | trial in Japan | EMA CT.gov | |
| FDA 2024-08-14 | seladelpar Livdelzi | Treat primary biliary cholangitis | Gilead Sciences United States | small molecule | Yes | none found Japan partner: Kaken Pharmaceutical Co., Ltd. | FDA MHLW | |
| FDA 2024-08-14 | axatilimab Niktimvo | Treat chronic graft-versus-host disease | Incyte United States | antibody | Yes | trial in Japan | FDA CT.gov MHLW | |
| EMA 2024-08-01 | rADAMTS13 | Treatment of congenital thrombotic thrombocytopenic purpura (cTTP) due to ADAMTS13 deficiency | Takeda Japan | small molecule | — | trial in Japan | EMA CT.gov jRCT | |
| FDA 2024-07-25 | deuruxolitinib Leqselvi | Treat severe alopecia areata | Sun Pharma India | small molecule | No | trial in Japan | FDA CT.gov jRCT | |
| EMA 2024-07-24 | sugemalimab | First line treatment of adults with metastatic non small cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK,… | CStone Pharmaceuticals China | antibody | — | none found | EMA | |
| EMA 2024-06-28 | chikungunya vaccine (live) | Active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older at… | Valneva France | vaccine | — | none found | EMA | |
| FDA 2024-06-26 | ensifentrine Ohtuvayre | Treat chronic obstructive pulmonary disease | Merck & Co. (MSD) United States | small molecule | No | none found | FDA | |
| FDA 2024-06-10 EMA 2024-09-19 | elafibranor Iqirvo | Treat primary biliary cholangitis | Ipsen France | small molecule | Yes | trial in Japan | FDA EMA CT.gov MHLW | |
| FDA 2024-06-06 EMA 2025-03-07 | imetelstat Rytelo | Treat low- to intermediate-1 risk myelodysplastic syndromes | Geron United States | small molecule | Yes | none found | FDA EMA | |
| FDA 2024-04-26 EMA 2026-04-27 | mavorixafor Xolremdi | Treat WHIM syndrome | X4 Pharmaceuticals United States | small molecule | Yes | none found | FDA EMA | |
| FDA 2024-04-22 EMA 2026-02-16 | nogapendekin alfa inbakicept Anktiva | Treat bladder cancer | ImmunityBio United States | protein/enzyme | No | none found | FDA EMA | |
| FDA 2024-04-17 | pegulicianine Lumisight | Optical imaging agent for cancerous tissue detection | Lumicell United States | diagnostic agent | No | none found | FDA | |
| FDA 2024-04-03 | ceftobiprole medocaril sodium Zevtera | Treat bloodstream infections and bacterial pneumonia | Basilea (US: Innoviva Specialty Therapeutics) Switzerland | small molecule | No | none found | FDA | |
| FDA 2024-03-21 EMA 2025-06-06 | givinostat Duvyzat | Treat Duchenne muscular dystrophy | Italfarmaco Italy | small molecule | Yes | none found Japan partner: JCR Pharmaceuticals Co., Ltd. | FDA EMA MHLW | |
| FDA 2024-03-19 | aprocitentan Tryvio | Treat hypertension | Idorsia Switzerland | small molecule | No | none found | FDA | |
| FDA 2024-03-14 EMA 2025-08-18 | resmetirom Rezdiffra | Treat noncirrhotic MASH with liver scarring | Madrigal Pharmaceuticals United States | small molecule | No | none found | FDA EMA | |
| FDA 2024-02-29 | letibotulinumtoxinA Letybo | Improve glabellar lines | Hugel South Korea | protein/enzyme | No | none found | FDA | |
| FDA 2024-02-22 EMA 2024-03-21 | cefepime, enmetazobactam Exblifep | Treat complicated urinary tract infections | Advanz Pharma United Kingdom | small molecule | No | none found | FDA EMA | |
| EMA 2024-02-09 | exagamglogene autotemcel | Treatment of patients aged 2 years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises | Vertex Pharmaceuticals United States | cell/gene therapy | — | none found | EMA | |
| FDA 2024-01-05 | berdazimer Zelsuvmi | Treat molluscum contagiosum | LNHC / Pelthos Therapeutics United States | small molecule | No | none found | FDA | |
| FDA 2023-12-21 EMA 2025-03-06 | eplontersen Wainua | Treat hereditary transthyretin-mediated amyloidosis polyneuropathy | AstraZeneca United Kingdom | oligonucleotide (ASO) | Yes | trial in Japan | FDA EMA CT.gov MHLW | |
| FDA 2026-02-23 EMA 2023-12-15 | pegzilarginase Loargys | Treat hyperarginemia in Arginase 1 Deficiency | Immedica Sweden | protein/enzyme | Yes | none found | FDA EMA MHLW | |
| FDA 2023-11-27 EMA 2025-08-14 | nirogacestat Ogsiveo | Treat progressing desmoid tumors | Merck KGaA (SpringWorks) Germany | small molecule | Yes | trial in Japan | FDA EMA CT.gov jRCT MHLW | |
| FDA 2023-11-16 EMA 2024-03-21 | efbemalenograstim alfa Ryzneuta | Decrease febrile neutropenia incidence | Evive Biotech China | protein/enzyme | No | none found | FDA EMA | |
| FDA 2023-11-15 | taurolidine, heparin Defencath | Reduce catheter-related bloodstream infections in hemodialysis | CorMedix United States | small molecule | No | none found | FDA | |
| FDA 2023-10-27 EMA 2024-09-19 | toripalimab Loqtorzi | Treat recurrent or metastatic nasopharyngeal carcinoma | Coherus / Junshi United States | antibody | Yes | none found | FDA EMA | |
| FDA 2023-10-26 EMA 2023-12-14 | vamorolone Agamree | Treat Duchenne muscular dystrophy | Catalyst Pharmaceuticals United States | small molecule | Yes | Japan deal Japan partner: Nxera Pharma | FDA EMA biospace.com | |
| FDA 2023-09-29 | nedosiran Rivfloza | Treat primary hyperoxaluria type 1 | Novo Nordisk Denmark | oligonucleotide (siRNA) | Yes | trial in Japan | FDA CT.gov | |
| FDA 2023-09-22 | gepirone Exxua | Treat major depressive disorder | Fabre-Kramer United States | small molecule | No | none found | FDA | |
| EMA 2023-09-15 | cedazuridine / decitabine | Indicated for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated,… | Otsuka Japan | small molecule | — | trial in Japan | EMA CT.gov | |
| FDA 2023-09-08 | motixafortide Aphexda | Mobilize hematopoietic stem cells | Ayrmid / BioLineRx Israel | peptide | Yes | Japan deal Japan partner: GloriaBio (Asia rights holder, non-Japanese) | FDA ir.biolinerx.com | |
| FDA 2023-08-18 | pozelimab Veopoz | Treat CD55-deficient protein-losing enteropathy (CHAPLE disease) | Regeneron United States | antibody | Yes | trial in Japan | FDA CT.gov | |
| FDA 2023-07-25 | lotilaner Xdemvy | Treat Demodex blepharitis | Tarsus Pharmaceuticals United States | small molecule | No | none found | FDA | |
| FDA 2023-06-15 EMA 2023-07-07 | glofitamab Columvi | Treat diffuse large B-cell lymphoma | Roche Switzerland | antibody | No | trial in Japan Japan partner: Chugai Pharmaceutical Co., Ltd. | FDA EMA CT.gov MHLW | |
| EMA 2023-06-06 | respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) | Active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults… | GSK United Kingdom | vaccine | — | none found | EMA | |
| FDA 2023-05-25 | flotufolastat F 18 Posluma | PET imaging in prostate cancer | Blue Earth Diagnostics (Bracco) Italy | radiopharmaceutical | No | none found | FDA | |
| FDA 2023-05-23 | sulbactam, durlobactam Xacduro | Treat hospital-acquired and ventilator-associated bacterial pneumonia | Innoviva United States | small molecule | No | none found | FDA | |
| FDA 2023-05-18 | perfluorhexyloctane Miebo | Treat dry eye disease | Bausch Health Canada | small molecule | No | none found | FDA | |
| FDA 2023-05-12 EMA 2023-12-07 | fezolinetant Veozah | Treat moderate-to-severe menopausal hot flashes | Astellas Japan | small molecule | No | trial in Japan | FDA EMA CT.gov jRCT | |
| FDA 2023-05-09 EMA 2023-05-04 | pegunigalsidase alfa Elfabrio | Treat Fabry disease | Chiesi Italy | protein/enzyme | No | trial in Japan | FDA EMA CT.gov | |
| FDA 2023-03-22 EMA 2023-12-22 | rezafungin Rezzayo | Treat candidemia and invasive candidiasis | Cidara / Mundipharma United States | small molecule | Yes | none found | FDA EMA | |
| FDA 2023-03-10 EMA 2026-08-20 | trofinetide Daybue | Treat Rett syndrome | Acadia Pharmaceuticals United States | peptide | Yes | none found | FDA EMA MHLW | |
| FDA 2023-03-09 | zavegepant Zavzpret | Treat migraine | Pfizer United States | small molecule | No | none found | FDA | |
| FDA 2023-02-28 EMA 2024-02-09 | omaveloxolone Skyclarys | Treat Friedreich's ataxia | Biogen United States | small molecule | Yes | none found | FDA EMA | |
| EMA 2023-02-20 | etranacogene dezaparvovec | Treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: currently use Factor IX prophylaxis therapy, or;… | CSL Australia | cell/gene therapy | — | none found | EMA MHLW | |
| FDA 2023-02-17 EMA 2024-04-19 | sparsentan Filspari | Reduce proteinuria in primary IgA nephropathy | Travere Therapeutics United States | small molecule | Yes | none found | FDA EMA MHLW | |
| FDA 2023-01-27 EMA 2023-09-15 | elacestrant Orserdu | Treat ESR1-mutated advanced or metastatic breast cancer | Menarini Italy | small molecule | No | trial in Japan | FDA EMA CT.gov | |
| FDA 2023-01-20 | bexagliflozin Brenzavvy | Improve glycemic control in type 2 diabetes | TheracosBio United States | small molecule | No | trial in Japan | FDA CT.gov | |
| FDA 2022-12-28 EMA 2023-05-31 | ublituximab Briumvi | Treat relapsing forms of multiple sclerosis | TG Therapeutics United States | antibody | No | none found | FDA EMA | |
| FDA 2022-12-23 | hyperpolarized Xe-129 Xenoview | MRI evaluation of lung ventilation | Polarean United States | radiopharmaceutical | No | none found | FDA | |
| EMA 2022-12-16 | tabelecleucel | Monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr… | Pierre Fabre France | cell/gene therapy | — | none found | EMA | |
| FDA 2022-12-12 EMA 2024-01-05 | adagrasib Krazati | Treat KRAS G12C-mutated non-small cell lung cancer | Bristol Myers Squibb United States | small molecule | Yes | trial in Japan Japan partner: Chugai Pharmaceutical | FDA EMA CT.gov | |
| FDA 2022-12-01 | olutasidenib Rezlidhia | Treat IDH1-mutated acute myeloid leukemia | Rigel Pharmaceuticals United States | small molecule | Yes | Japan deal Japan partner: Kissei Pharmaceutical | FDA ssl4.eir-parts.net CT.gov jRCT | |
| FDA 2022-11-18 EMA 2026-01-08 | teplizumab Tzield | Delay onset of stage 3 type 1 diabetes | Sanofi France | antibody | Yes | trial in Japan | FDA EMA CT.gov jRCT | |
| FDA 2022-09-29 | sodium phenylbutyrate and taurursodiol Relyvrio | Treat amyotrophic lateral sclerosis | Amylyx United States | small molecule | Yes | none found | FDA MHLW | |
| FDA 2022-09-21 EMA 2023-12-07 | gadopiclenol Elucirem | MRI contrast agent to detect and visualize lesions | Guerbet France | diagnostic agent | No | trial in Japan | FDA EMA CT.gov jRCT | |
| FDA 2022-09-14 | terlipressin Terlivaz | Improve kidney function in hepatorenal syndrome | Mallinckrodt Ireland | peptide | Yes | trial in Japan | FDA CT.gov | |
| FDA 2022-09-09 | eflapegrastim Rolvedon | Decrease infection incidence in chemotherapy-induced neutropenia | Assertio (Spectrum) United States | protein/enzyme | No | none found | FDA | |
| FDA 2022-09-07 | daxibotulinumtoxinA Daxxify | Improve glabellar lines | Crown Labs (Revance) United States | protein/enzyme | Yes | trial in Japan Japan partner: Eisai Co., Ltd. | FDA CT.gov | |
| EMA 2022-08-24 | valoctocogene roxaparvovec | Treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL)… | BioMarin United States | cell/gene therapy | — | trial in Japan | EMA CT.gov MHLW | |
| EMA 2022-07-18 | eladocagene exuparvovec | Treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency | PTC Therapeutics United States | cell/gene therapy | — | none found | EMA | |
| EMA 2022-07-15 | eptacog beta (activated) | Adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in… | LFB France | protein/enzyme | — | none found | EMA | |
| EMA 2022-05-25 | ciltacabtagene autoleucel | Treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a… | Johnson & Johnson United States | cell/gene therapy | — | trial in Japan | EMA CT.gov | |
| FDA 2022-04-26 | oteseconazole Vivjoa | Reduce recurrent vulvovaginal candidiasis | Mycovia Pharmaceuticals United States | small molecule | No | none found | FDA | |
| EMA 2022-04-04 | lisocabtagene maraleucel | Treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise… | Bristol Myers Squibb United States | cell/gene therapy | — | trial in Japan | EMA CT.gov | |
| FDA 2022-03-18 EMA 2023-07-26 | ganaxolone Ztalmy | Treat seizures in CDKL5 deficiency disorder | Immedica Sweden | small molecule | Yes | none found | FDA EMA | |
| FDA 2022-03-18 EMA 2022-09-15 | nivolumab and relatlimab Opdualag | Treat unresectable or metastatic melanoma | Bristol Myers Squibb United States | antibody | Yes | trial in Japan Japan partner: Ono Pharmaceutical Co., Ltd. | FDA EMA CT.gov MHLW | |
| FDA 2022-02-28 | pacritinib Vonjo | Treat myelofibrosis with low platelets | Sobi Sweden | small molecule | Yes | trial in Japan | FDA CT.gov | |
| FDA 2022-02-17 EMA 2022-11-09 | mitapivat Pyrukynd | Treat hemolytic anemia in pyruvate kinase deficiency | Agios United States | small molecule | Yes | trial in Japan | FDA EMA CT.gov | |
| FDA 2022-01-25 EMA 2022-04-01 | tebentafusp Kimmtrak | Treat unresectable or metastatic uveal melanoma | Immunocore United Kingdom | protein/enzyme | Yes | none found | FDA EMA | |
| FDA 2021-11-29 | pafolacianine Cytalux | Help identify ovarian cancer lesions | On Target Laboratories United States | diagnostic agent | Yes | none found | FDA | |
| EMA 2021-11-15 | diroximel fumarate | Treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5.1 for important information on the… | Biogen United States | small molecule | — | trial in Japan | EMA CT.gov | |
| FDA 2021-09-15 | mobocertinib Exkivity | Treat NSCLC with EGFR exon 20 insertions | Takeda Japan | small molecule | Yes | trial in Japan | FDA CT.gov jRCT | |
| FDA 2021-08-25 EMA 2022-01-11 | lonapegsomatropin Skytrofa | Treat growth hormone deficiency | Ascendis Pharma Denmark | peptide | Yes | trial in Japan | FDA EMA CT.gov | |
| EMA 2021-08-18 | idecabtagene vicleucel | Treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an… | Bristol Myers Squibb United States | cell/gene therapy | — | trial in Japan | EMA CT.gov | |
| FDA 2021-07-16 | fexinidazole Fexinidazole | Treat human African trypanosomiasis | Sanofi France | small molecule | Yes | none found | FDA | |
| FDA 2021-06-30 | asparaginase erwinia chrysanthemi Rylaze | Treat acute lymphoblastic leukemia and lymphoblastic lymphoma | Jazz Pharmaceuticals Ireland | protein/enzyme | Yes | none found | FDA | |
| FDA 2021-06-07 | aducanumab Aduhelm | Treat Alzheimer's disease | Biogen United States | antibody | No | trial in Japan | FDA CT.gov | |
| FDA 2021-06-01 | ibrexafungerp Brexafemme | Treat vulvovaginal candidiasis | GSK United Kingdom | small molecule | No | none found | FDA | |
| FDA 2021-05-28 | olanzapine and samidorphan Lybalvi | Treat schizophrenia and bipolar I disorder | Alkermes Ireland | small molecule | No | none found | FDA | |
| FDA 2021-05-28 | infigratinib Truseltiq | Treat cholangiocarcinoma with FGFR2 fusion | Helsinn Switzerland | small molecule | Yes | trial in Japan Japan partner: Kyowa Kirin Co., Ltd. | FDA CT.gov jRCT | |
| FDA 2021-05-26 EMA 2023-11-27 | piflufolastat F 18 Pylarify | PSMA PET imaging in prostate cancer | Lantheus United States | radiopharmaceutical | No | trial in Japan | FDA EMA CT.gov | |
| FDA 2021-04-23 EMA 2022-12-20 | loncastuximab tesirine Zynlonta | Treat relapsed or refractory large B-cell lymphoma | ADC Therapeutics Switzerland | antibody-drug conjugate | Yes | trial in Japan Japan partner: Tanabe Pharma Corporation | FDA EMA CT.gov jRCT MHLW | |
| FDA 2021-04-22 EMA 2021-04-21 | dostarlimab Jemperli | Treat dMMR endometrial cancer | GSK United Kingdom | antibody | No | trial in Japan | FDA EMA CT.gov | |
| FDA 2021-04-02 | viloxazine Qelbree | Treat ADHD | Supernus United States | small molecule | No | none found | FDA | |
| FDA 2021-03-22 EMA 2024-07-24 | dasiglucagon Zegalogue | Treat severe hypoglycemia | Zealand Pharma Denmark | peptide | No | trial in Japan | FDA EMA CT.gov jRCT | |
| FDA 2021-03-18 EMA 2021-05-19 | ponesimod Ponvory | Treat relapsing forms of multiple sclerosis | Vanda Pharmaceuticals United States | small molecule | No | none found | FDA EMA | |
| FDA 2021-03-02 | serdexmethylphenidate and dexmethylphenidate Azstarys | Treat ADHD | Corium (Commave) United States | small molecule | No | none found | FDA | |
| FDA 2021-02-26 EMA 2022-09-15 | fosdenopterin Nulibry | Reduce mortality in molybdenum cofactor deficiency type A | Sentynl Therapeutics (Zydus) United States | small molecule | Yes | none found | FDA EMA | |
| FDA 2021-02-26 EMA 2022-08-17 | melphalan flufenamide Pepaxto | Treat relapsed or refractory multiple myeloma | Oncopeptides Sweden | small molecule | Yes | MHLW development request IVS-25: company = サンドファーマ株式会社 | MHLW request Japan partner: サンドファーマ株式会社 | FDA EMA MHLW |
| FDA 2021-02-25 | casimersen Amondys 45 | Treat Duchenne muscular dystrophy (exon 45 skipping) | Sarepta United States | oligonucleotide (ASO) | Yes | none found | FDA | |
| FDA 2021-02-12 | trilaciclib Cosela | Reduce chemotherapy-induced myelosuppression in small cell lung cancer | Pharmacosmos Denmark | small molecule | No | none found | FDA | |
| FDA 2021-02-05 | umbralisib Ukoniq | Treat marginal zone and follicular lymphoma | TG Therapeutics United States | small molecule | Yes | trial in Japan | FDA CT.gov | |
| FDA 2020-12-21 | ansuvimab-zykl Ebanga | Treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is… | Ridgeback Biotherapeutics United States | antibody | Yes | No. 15, group B (development need high) | none found | FDA MHLW |
| EMA 2020-12-21 | COVID-19 mRNA vaccine | Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older | BioNTech Germany | vaccine | — | trial in Japan Japan partner: Takeda | EMA CT.gov jRCT | |
| EMA 2020-12-17 | defatted powder of Arachis hypogaea L., semen (peanuts) | Treatment of patients aged 1 to 17 years with a confirmed diagnosis of peanut allergy | Stallergenes Greer France | small molecule | — | none found | EMA | |
| EMA 2020-12-17 | autologous CD34+ cells encoding ARSA gene | Treatment of metachromatic leukodystrophy (MLD) characterized by biallelic mutations in the arysulfatase A (ARSA) gene leading to… | Kyowa Kirin Japan | cell/gene therapy | — | none found | EMA | |
| FDA 2020-12-16 | margetuximab-cmkb Margenza | MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast… | TerSera Therapeutics United States | antibody | No | No. 16, group B (development need high); MHLW drug-loss request R7-7 (margetuximab-cmkb) | none found | FDA MHLW |
| FDA 2020-12-14 EMA 2021-07-16 | tirbanibulin Klisyri | Field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults | Almirall Spain | small molecule | No | none found | FDA EMA | |
| EMA 2020-12-14 | brexucabtagene autoleucel | Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL) | Gilead Sciences United States | cell/gene therapy | — | trial in Japan | EMA CT.gov MHLW | |
| FDA 2020-11-25 | naxitamab-gqgk Danyelza | In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of… | Y-mAbs Therapeutics United States | antibody | Yes | No. 17, group B (development need high) | none found Japan partner: Nobelpharma Co., Ltd. | FDA MHLW |
| FDA 2020-11-23 EMA 2020-11-19 | lumasiran sodium Oxlumo | Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients | Alnylam United States | oligonucleotide (siRNA) | Yes | No. 1, group A (development need especially high); MHLW drug-loss request R6-1 (lumasiran sodium), evaluated at the unapproved-drug committee 第63回(令和7年5月9日) で評価 | none found | FDA EMA MHLW |
| EMA 2020-11-16 | quadrivalent influenza vaccine (recombinant, prepared in cell culture) | Active immunization for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek… | Sanofi France | vaccine | — | none found | EMA | |
| FDA 2020-10-14 | atoltivimab / odesivimab / maftivimab Inmazeb | Treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is… | Regeneron United States | antibody | Yes | No. 18, group B (development need high) | none found | FDA MHLW |
| FDA 2020-09-04 EMA 2021-11-18 | pralsetinib Gavreto | Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved… | Rigel Pharmaceuticals United States | small molecule | Yes | trial in Japan | FDA EMA CT.gov | |
| FDA 2020-09-03 | copper cu-64 dotatate Detectnet | Indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine… | Curium France | radiopharmaceutical | Yes | No. 2, group A (development need especially high); MHLW drug-loss request R6-3 (Copper Cu 64 dotatate) | none found | FDA MHLW |
| FDA 2020-08-26 EMA 2025-10-17 | clascoterone Winlevi | Treatment of acne vulgaris | Sun Pharma India | small molecule | No | No. 80, already resolved (in development in Japan or withdrawn abroad) | none found | FDA EMA MHLW |
| EMA 2020-08-25 | imlifidase | Desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available… | Hansa Biopharma Sweden | protein/enzyme | — | No. 56, group C (development need low) | none found | EMA MHLW |
| EMA 2020-08-21 | ivacaftor / tezacaftor / elexacaftor | Treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic… | Vertex Pharmaceuticals United States | small molecule | — | No. 28, group B (development need high); MHLW drug-loss request R7-14 (elexacaftor / ivacaftor / tezacaftor); MHLW open call R7-14: company = なし | MHLW open call | EMA MHLW |
| FDA 2020-08-07 | oliceridine Olinvyk | Adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative… | Trevena United States | small molecule | No | No. 19, group B (development need high); MHLW drug-loss request R7-4 (oliceridine) | none found | FDA MHLW |
| FDA 2020-08-06 | nifurtimox Lampit | Pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease… | Bayer Germany | small molecule | Yes | No. 20, group B (development need high) | none found | FDA MHLW |
| FDA 2026-05-22 EMA 2020-07-31 | bulevirtide Hepcludex | Treat chronic hepatitis delta virus infection | Gilead Sciences United States | peptide | Yes | No. 57, group C (development need low) | none found | FDA EMA MHLW |
| FDA 2020-07-24 | abametapir Xeglyze | アバメタピル アタマジラミの局所治療 | LNHC / Pelthos Therapeutics United States | small molecule | No | No. 21, group B (development need high); MHLW drug-loss request R7-18 (abametapir) | none found | FDA MHLW |
| FDA 2020-07-02 EMA 2021-02-04 | fostemsavir tromethamine Rukobia | Treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive… | GSK United Kingdom | small molecule | No | No. 58, group C (development need low) | none found | FDA EMA MHLW |
| FDA 2020-06-15 EMA 2026-05-29 | lurbinectedin Zepzelca | Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after prior… | Jazz Pharmaceuticals Ireland | small molecule | Yes | trial in Japan Japan partner: Daiichi Sankyo | FDA EMA CT.gov MHLW | |
| FDA 2020-05-26 EMA 2021-11-22 | artesunate Artesunate | Initial treatment of severe malaria in adult and pediatric patients | Amivas United States | small molecule | Yes | No. 4, group A (development need especially high); MHLW drug-loss request R6-5 (artesunate); MHLW open call R6-5: company = J-ENTRY Consortium | MHLW open call Japan partner: J-ENTRY Consortium | FDA EMA MHLW |
| FDA 2020-05-20 | fluoroestradiol f-18 Cerianna | Use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to… | GE HealthCare United States | radiopharmaceutical | No | No. 22, group B (development need high); MHLW drug-loss request R7-1 (fluoroestradiol F18), evaluated at the unapproved-drug committee 第66回(令和7年12月12日) で評価; MHLW development request R7-1: company = GEヘルスケア・ファーマ株式会社 | MHLW request Japan partner: GEヘルスケア・ファーマ株式会社 | FDA MHLW |
| EMA 2020-05-18 | onasemnogene abeparvovec | Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic… | Novartis Switzerland | cell/gene therapy | — | trial in Japan | EMA CT.gov | |
| FDA 2020-05-15 EMA 2021-11-18 | ripretinib Qinlock | Treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more… | Ono Pharmaceutical Japan | small molecule | Yes | No. 23, group B (development need high); MHLW drug-loss request R7-19 (ripretinib); MHLW development request R7-19: company = 小野薬品工業株式会社 | MHLW request Japan partner: 小野薬品工業株式会社 | FDA EMA CT.gov MHLW |
| EMA 2020-04-01 | cholera vaccine, oral, live | Active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older | Bavarian Nordic Denmark | vaccine | — | none found | EMA | |
| FDA 2020-02-26 | amisulpride Barhemsys | Adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a… | Eagle (Acacia) United States | small molecule | No | No. 24, group B (development need high); MHLW drug-loss request R7-8 (amisulpride), evaluated at the unapproved-drug committee 第67回(令和8年2月6日) で評価; MHLW open call R7-8: company = なし | MHLW open call | FDA MHLW |
| FDA 2020-01-09 EMA 2020-09-24 | avapritinib Ayvakit | Treatment of adult patients with advanced systemic mastocytosis (AdvSM) | Sanofi France | small molecule | Yes | No. 5, group A (development need especially high); MHLW drug-loss request R6-9 (avapritinib); MHLW open call R6-9: company = なし | MHLW open call | FDA EMA MHLW |
| FDA 2019-12-23 | ubrogepant Ubrelvy | ウブロゲパント 片頭痛 | AbbVie United States | small molecule | No | No. 25, group B (development need high); MHLW drug-loss request R7-3 (ubrogepant) | none found | FDA MHLW |
| FDA 2019-12-20 | lumateperone tosylate Caplyta | CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Treatment of depressive episodes… | Johnson & Johnson United States | small molecule | No | No. 26, group B (development need high); MHLW drug-loss request R8-4 (lumateperone) | none found | FDA MHLW |
| FDA 2019-12-20 | brilliant blue g Tissueblue | Selectively stain the internal limiting membrane (ILM) | D.O.R.C. (Dutch Ophthalmic Research Center) Netherlands | small molecule | No | none found | FDA | |
| EMA 2019-12-18 | esketamine | Adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with… | Johnson & Johnson United States | small molecule | — | trial in Japan Japan partner: Janssen Pharmaceutical K.K. | EMA CT.gov | |
| FDA 2019-12-12 | golodirsen Vyondys 53 | Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon… | Sarepta United States | oligonucleotide (ASO) | Yes | No. 59, group C (development need low) | none found | FDA MHLW |
| FDA 2019-11-25 EMA 2022-02-14 | voxelotor Oxbryta | Treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older | Pfizer United States | small molecule | Yes | No. 67, group D (no development need) | none found | FDA EMA MHLW |
| FDA 2019-11-15 EMA 2020-10-28 | crizanlizumab-tmca Adakveo | Reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell… | Novartis Switzerland | antibody | Yes | No. 68, group D (no development need) | none found | FDA EMA MHLW |
| EMA 2019-11-11 | ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live) | Active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire… | Merck & Co. (MSD) United States | vaccine | — | none found | EMA | |
| FDA 2019-11-07 | air polymer-type a Exem Foam Kit | Sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility | Giskit Netherlands | diagnostic agent | No | No. 27, group B (development need high); MHLW drug-loss request R7-2 (air polymer-type A); MHLW open call R7-2: company = なし | MHLW open call | FDA MHLW |
| FDA 2019-10-10 | fluorodopa f-18 Fluorodopa F18 | Use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult… | Feinstein Institutes (academic) United States | radiopharmaceutical | No | No. 29, group B (development need high); MHLW drug-loss request R7-12 (fluorodopa F18) | none found | FDA MHLW |
| FDA 2019-10-04 | trifarotene Aklief | Topical treatment of acne vulgaris in patients 9 years of age and older | Galderma Switzerland | small molecule | No | No. 6, group A (development need especially high); MHLW drug-loss request R6-2 (trifarotene); MHLW open call R6-2: company = なし | MHLW open call | FDA MHLW |
| FDA 2019-08-21 | gallium ga-68 edotreotide Gallium Ga 68 Edotreotide | Use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs)… | University of Iowa Hospitals (academic) United States | radiopharmaceutical | No | No. 7, group A (development need especially high) | none found | FDA MHLW |
| FDA 2019-08-19 EMA 2020-07-27 | lefamulin acetate Xenleta | Treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that… | Hepalink (King-Friend) / Nabriva asset China | small molecule | No | No. 8, group A (development need especially high); MHLW drug-loss request R6-6 (lefamulin acetate); MHLW open call R6-6: company = なし | MHLW open call | FDA EMA MHLW |
| FDA 2019-08-14 EMA 2020-07-31 | pretomanid Pretomanid | Pretomanid tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with… | Viatris United States | small molecule | Yes | No. 9, group A (development need especially high); MHLW development request IV-202: company = ヴィアトリス製薬合同会社 | MHLW request Japan partner: ヴィアトリス製薬合同会社 | FDA EMA CT.gov jRCT MHLW |
| FDA 2019-08-02 | pexidartinib hydrochloride Turalio | Treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional… | Daiichi Sankyo Japan | small molecule | Yes | none found | FDA | |
| FDA 2019-07-03 EMA 2021-03-26 | selinexor Xpovio | Combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have… | Karyopharm United States | small molecule | Yes | trial in Japan | FDA EMA CT.gov | |
| FDA 2019-06-21 | bremelanotide acetate Vyleesi (Autoinjector) | Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low… | Cosette Pharmaceuticals United States | peptide | No | No. 30, group B (development need high) | none found | FDA MHLW |
| FDA 2025-01-21 EMA 2019-06-20 | treosulfan Grafapex | Preparative regimen for allogeneic hematopoietic stem cell transplantation | Medexus Canada | small molecule | Yes | none found Japan partner: nippon medac Co., Ltd. | FDA EMA MHLW | |
| FDA 2019-05-24 EMA 2020-07-27 | alpelisib Piqray | Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth… | Novartis Switzerland | small molecule | Yes | trial in Japan | FDA EMA CT.gov | |
| EMA 2019-05-03 | volanesorsen | An adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for… | Ionis United States | oligonucleotide (ASO) | — | No. 60, group C (development need low) | none found | EMA MHLW |
| FDA 2023-05-26 EMA 2019-04-26 | sotagliflozin Inpefa | Treat heart failure | Lexicon Pharmaceuticals United States | small molecule | No | No. 69, group D (no development need) | none found | FDA EMA MHLW |
| FDA 2019-03-20 EMA 2020-01-16 | solriamfetol hydrochloride Sunosi | Improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy | Axsome Therapeutics United States | small molecule | Yes | No. 31, group B (development need high); MHLW drug-loss request R8-2 (solriamfetol); MHLW open call R8-2: company = なし | Japan deal Japan partner: SK biopharmaceuticals (originator keeps Japan rights, non-Japanese) | FDA EMA investor.jazzpharma.com MHLW |
| FDA 2019-03-19 | brexanolone Zulresso | ブレキサノロン 産後うつ病 (PPD) 学会からの医療ニーズに関する回答提出が (ズルレッソ) 遅れたため、「未承認薬等迅速解消促進調査 事業」において情報を整理 | Supernus United States | small molecule | No | No. 10, group A (development need especially high) | none found | FDA MHLW |
| FDA 2019-02-13 | triclabendazole Egaten | Treatment of fascioliasis in patients 6 years of age and older | Novartis Switzerland | small molecule | Yes | No. 32, group B (development need high) | none found | FDA MHLW |
| FDA 2019-02-01 | prabotulinumtoxina-xvfs Jeuveau | Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle… | Evolus United States | protein/enzyme | No | No. 70, group D (no development need) | none found | FDA MHLW |
| FDA 2018-12-20 | calaspargase pegol-mknl Asparlas | A component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and | Servier France | protein/enzyme | No | No. 33, group B (development need high) | none found | FDA MHLW |
| FDA 2018-11-16 | rifamycin sodium Aemcolo | リファマイシン 旅行者下痢 | Cosmo Pharmaceuticals Ireland | small molecule | No | No. 61, group C (development need low) | none found | FDA MHLW |
| FDA 2018-11-09 | revefenacin Yupelri | Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) | Viatris United States | small molecule | No | No. 37, group B (development need high); MHLW drug-loss request R7-6 (revefenacin) | none found | FDA MHLW |
| FDA 2018-10-02 | omadacycline tosylate Nuzyra | Treatment of adult patients with the following infections caused by susceptible microorganisms ( 1 ): | Paratek United States | small molecule | No | No. 11, group A (development need especially high); MHLW drug-loss request R6-7 (omadacycline tosylate); MHLW open call R6-7: company = なし | MHLW open call | FDA MHLW |
| FDA 2018-10-01 | sarecycline hydrochloride Seysara | Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older | Almirall Spain | small molecule | No | No. 34, group B (development need high); MHLW drug-loss request R8-6 (sarecycline); MHLW open call R8-6: company = なし | MHLW open call | FDA MHLW |
| FDA 2018-09-13 EMA 2021-02-08 | moxetumomab pasudotox-tdfk Lumoxiti | Treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic… | AstraZeneca United Kingdom | antibody-drug conjugate | Yes | No. 71, group D (no development need) | none found | FDA EMA MHLW |
| FDA 2018-08-27 EMA 2018-09-20 | eravacycline dihydrochloride Xerava | Adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal… | Melinta United States | small molecule | No | No. 35, group B (development need high); MHLW drug-loss request R7-16 (eravacycline dihydrochloride); MHLW open call R7-16: company = なし | MHLW open call | FDA EMA MHLW |
| FDA 2018-08-10 | ethinyl estradiol / segesterone acetate Annovera | セゲステロン酢酸エステル、エチ 避妊薬 ニルエストラジオール | Mayne Pharma Australia | small molecule | No | No. 36, group B (development need high); MHLW drug-loss request R8-1 (segesterone acetate and ethinyl estradiol vaginal system), evaluated at the unapproved-drug committee 第68回(令和8年5月25日) で評価; MHLW open call R8-1: company = なし | trial in Japan | FDA CT.gov MHLW |
| FDA 2018-07-27 | fish oil triglycerides Omegaven | A source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC) | Fresenius Germany | small molecule | Yes | No. 12, group A (development need especially high) | none found | FDA MHLW |
| FDA 2018-07-23 | elagolix sodium Orilissa | Management of moderate to severe pain associated with endometriosis | AbbVie United States | small molecule | No | No. 38, group B (development need high); MHLW drug-loss request R7-13 (elagolix) | none found | FDA MHLW |
| FDA 2018-07-20 | tafenoquine succinate Krintafel | Radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving… | GSK United Kingdom | small molecule | Yes | No. 73, group D (no development need) | none found | FDA MHLW |
| FDA 2018-06-25 | plazomicin sulfate Zemdri | 1 | Cipla India | small molecule | No | No. 39, group B (development need high); MHLW drug-loss request R7-17 (plazomicin sulfate); MHLW open call R7-17: company = なし | MHLW open call | FDA MHLW |
| FDA 2018-06-13 | moxidectin Moxidectin | Treatment of onchocerciasis due to Onchocerca volvulus in adult and pediatric patients aged 4 years and older and weighing at… | Medicines Development for Global Health (non-profit) Australia | small molecule | Yes | No. 62, group C (development need low) | none found | FDA MHLW |
| FDA 2018-05-16 | lofexidine hydrochloride Lucemyra | Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults | US WorldMeds United States | small molecule | No | No. 40, group B (development need high) | none found | FDA MHLW |
| FDA 2023-02-16 EMA 2018-03-23 | velmanase alfa Lamzede | Treat non-CNS manifestations of alpha-mannosidosis | Chiesi Italy | protein/enzyme | Yes | No. 41, group B (development need high); MHLW drug-loss request R7-20 (velmanase alfa); MHLW development request R7-20: company = キエジ・ファーマ・ジャパン株式会社 | MHLW request Japan partner: キエジ・ファーマ・ジャパン株式会社 | FDA EMA MHLW |
| FDA 2018-03-06 EMA 2019-09-26 | ibalizumab-uiyk Trogarzo | Treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug… | Theratechnologies Canada | antibody | Yes | No. 63, group C (development need low) | trial in Japan | FDA EMA CT.gov jRCT MHLW |
| FDA 2018-02-12 EMA 2018-10-31 | ivacaftor / ivacaftor, tezacaftor Symdeko (Copackaged) | Treatment of cystic fibrosis (CF) in patients age 6 years and older who are homozygous for the F508del mutation or who have at… | Vertex Pharmaceuticals United States | small molecule | Yes | No. 42, group B (development need high); MHLW drug-loss request R7-15 (tezacaftor/ivacaftor); MHLW open call R7-15: company = なし | MHLW open call | FDA EMA MHLW |
| FDA 2017-12-19 EMA 2018-03-23 | ertugliflozin / sitagliptin phosphate Steglujan | Adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:… | Merck & Co. (MSD) United States | small molecule | No | No. 75, group D (no development need) | none found | FDA EMA MHLW |
| FDA 2017-12-19 EMA 2018-03-23 | ertugliflozin / metformin hydrochloride Segluromet | Adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in… | Merck & Co. (MSD) United States | small molecule | No | No. 74, group D (no development need) | none found | FDA EMA MHLW |
| EMA 2017-11-10 | padeliporfin Tookad | Monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life… | Steba Biotech Luxembourg | small molecule | — | No. 64, group C (development need low) | none found | EMA MHLW |
| FDA 2017-09-15 | secnidazole Solosec | SOLOSEC ® is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age… | Evofem United States | small molecule | No | No. 45, group B (development need high); MHLW drug-loss request R8-8 (secnidazole) | none found | FDA MHLW |
| FDA 2017-08-29 EMA 2018-11-20 | meropenem / vaborbactam Vabomere | Treatment of the following infections in adults: Complicated urinary tract infection (cUTI), including pyelonephritis Complicated… | Melinta United States | small molecule | No | No. 65, group C (development need low) | trial in Japan Japan partner: Shionogi | FDA EMA CT.gov MHLW |
| FDA 2017-08-29 | benznidazole Benznidazole | Treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi, in pediatric patients 2 to 12 years of age | Exeltis (Insud) Spain | small molecule | Yes | No. 46, group B (development need high) | none found | FDA MHLW |
| FDA 2017-08-18 EMA 2018-08-23 | allopurinol / lesinurad Duzallo | Adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate… | Grünenthal Germany | small molecule | No | No. 76, group D (no development need) | trial in Japan | FDA EMA CT.gov MHLW |
| FDA 2017-07-18 | sofosbuvir / velpatasvir / voxilaprevir Vosevi | Treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis… | Gilead Sciences United States | small molecule | No | No. 47, group B (development need high); MHLW drug-loss request R7-5 (sofosbuvir/velpatasvir/voxilaprevir); MHLW development request R7-5: company = ギリアド・サイエンシズ株式会社 | MHLW request Japan partner: ギリアド・サイエンシズ株式会社 | FDA CT.gov MHLW |
| FDA 2017-06-23 | betrixaban Bevyxxa | ベトリキサバン 静脈血栓塞栓症 | AstraZeneca (Portola) United Kingdom | small molecule | No | No. 48, group B (development need high) | none found | FDA MHLW |
| FDA 2017-02-28 EMA 2017-09-17 | telotristat etiprate Xermelo | Treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled… | TerSera Therapeutics United States | small molecule | Yes | No. 50, group B (development need high); MHLW drug-loss request R7-9 (telotristat etiprate); MHLW open call R7-9: company = なし | MHLW open call | FDA EMA MHLW |
| FDA 2017-02-09 | deflazacort Emflaza | Treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older | PTC Therapeutics United States | small molecule | Yes | No. 51, group B (development need high); MHLW drug-loss request R7-21 (deflazacort); MHLW open call R7-21: company = なし | MHLW open call | FDA MHLW |
| FDA 2017-01-19 | plecanatide Trulance | Adults for the treatment of: chronic idiopathic constipation (CIC) | Bausch Health Canada | peptide | No | No. 52, group B (development need high); MHLW drug-loss request R7-10 (plecanatide) | none found | FDA MHLW |
| FDA 2016-09-19 | eteplirsen Exondys 51 | Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon… | Sarepta United States | oligonucleotide (ASO) | Yes | No. 53, group B (development need high) | none found | FDA MHLW |
| FDA 2016-07-11 | lifitegrast Xiidra | Treatment of the signs and symptoms of dry eye disease (DED) | Bausch Health Canada | small molecule | No | No. 54, group B (development need high); MHLW drug-loss request R8-7 (lifitegrast) | none found | FDA MHLW |
| FDA 2016-06-01 | gallium dotatate ga-68 Netspot | For use after radiolabeling with Ga 68, with positron emission tomography (PET) for localization of somatostatin receptor… | Novartis Switzerland | radiopharmaceutical | Yes | No. 13, group A (development need especially high) | none found | FDA MHLW |
| FDA 2016-04-29 | pimavanserin tartrate Nuplazid | Treatment of hallucinations and delusions associated with Parkinson's disease psychosis [ see Clinical Studies (14) ] . NUPLAZID… | Acadia Pharmaceuticals United States | small molecule | No | No. 55, group B (development need high); MHLW drug-loss request R8-3 (pimavanserin tartrate); MHLW open call R8-3: company = なし | MHLW open call | FDA MHLW |
| FDA 2016-03-18 EMA 2020-11-18 | obiltoxaximab Anthim | Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate… | Elusys (Kindred) United States | antibody | Yes | No. 14, group A (development need especially high); MHLW drug-loss request R6-8 (obiltoxaximab); MHLW open call R6-8: company = あり(企業名未公表) | MHLW open call Japan partner: undisclosed company (per MHLW) | FDA EMA MHLW |
| FDA 2019-07-25 EMA 2016-02-18 | ferric maltol Accrufer | Treatment of iron deficiency in adults and adolescents aged 12 years and older | Norgine Netherlands | small molecule | No | No. 77, group D (no development need) | none found | FDA EMA MHLW |
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We prepare a one-page Japan entry snapshot for a single product: the likely regulatory route (orphan, priority, conditional, SAKIGAKE), whether a Japanese phase 1 is still expected, comparable Japanese approvals and their NHI prices, and Japanese companies that have in-licensed similar assets. Facts and official links only, no opinions sold as data.
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