PMDA · MHLW · monthly list
All drugs approved in Japan in December 2024, in English.
Last updated: 2026-10-02 · 25 approvals
Japan approved 25 drugs in December 2024 (approval date: 2024-12-27): 15 new active ingredient, 8 new indication, 1 biosimilar, 1 new dosage form. Median lag vs FDA for this month: 3.4 years (1,234 days) (n=12).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-12-27 | Zeposia ゼポジア | Ozanimod hydrochloride オザニモド塩酸塩 | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Treatment of moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments) 中等症から重症の潰瘍性大腸炎の治療(既存治療で効果不十分な場合に限る) | New active ingredient standard | 2020-03-25 | 2020-05-20 | 1,738 d 4.8 y | 1,682 d 4.6 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Zepbound ゼップバウンド | Tirzepatide チルゼパチド | Eli Lilly Japan K.K. 日本イーライリリー(株) | Treatment of obesity. For use only in patients with any of hypertension, hyperlipidemia or type 2 diabetes mellitus who have not responded sufficiently to diet therapy and exercise therapy, and meet the following conditions: • BMI of 27 kg/m2 or greater in the presence of at least two obesity-related comorbidities or • BMI of 35 kg/m2 or greater 肥満症 ただし、高血圧、脂質異常症又は2型糖尿病のいずれかを有し、食事療法・運動療法を行っても十分な効果が得られず、以下に該当する場合に限る。 ・BMIが27 kg/m2以上であり、2つ以上の肥満に関連する健康障害を有する ・BMIが35 kg/m2以上 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Vyvdura ヒフデュラ | Efgartigimod alfa and Vorhyaluronidase alfa エフガルチギモド アルファ(遺伝子組換え)/ボルヒアルロニダーゼ アルファ(遺伝子組換え) | Argenx Japan K.K. アルジェニクスジャパン(株) | Treatment of chronic inflammatory demyelinating polyneuropathy 慢性炎症性脱髄性多発根神経炎 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Ustekinumab BS ウステキヌマブBS | Ustekinumab [ustekinumab biosimilar 2] ウステキヌマブ(遺伝子組換え)[ウステキヌマブ後続2] | Yoshindo Inc. (株)陽進堂 | A biosimilar indicated for the treatment of the following disease in patients who have not sufficiently responded to conventional therapies: plaque psoriasis and psoriatic arthritis 既存治療で効果不十分な下記疾患 尋常性乾癬、乾癬性関節炎 | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Uptravi ウプトラビ | Selexipag セレキシパグ Orphan | Nippon Shinyaku Co., Ltd. 日本新薬(株) | , (2) Drugs with a new additional pediatric dosage and other characteristics and (3) a drug with a new additional pediatric dosage in an additional dosage form, indicated for the treatment of pulmonary arterial hypertension 肺動脈性肺高血圧症 | New dosage form orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Tepoxx テポックス | Tecovirimat hydrate テコビリマト水和物 | Japan Biotechno Pharma Co., Ltd. 日本バイオテクノファーマ(株) | Treatment of smallpox, mpox, cowpox, as well as complications due to replication of vaccinia virus following vaccination against smallpox 痘そう、エムポックス、牛痘、痘そうワクチン接種後のワクチニアウイルスの増殖による合併症 | New active ingredient standard | 2018-07-13 | 2022-01-06 | 2,359 d 6.5 y | 1,086 d 3.0 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Tecvayli テクベイリ | Teclistamab テクリスタマブ(遺伝子組換え) | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of relapsed or refractory multiple myeloma (for use only if refractory or intolerant to standard therapies) 再発又は難治性の多発性骨髄腫(標準的な治療が困難な場合に限る) | New active ingredient orphanpriority | 2022-10-25 | 2022-08-23 | 794 d 2.2 y | 857 d 2.3 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Tauvid タウヴィッド | Flortaucipir (18F) フロルタウシピル(18F) | PDRadiopharma Inc. PDRファーマ(株) | Support of selection of patients with mild cognitive impairment and mild dementia due to Alzheimer's disease, for whom donanemab (genetical recombination) is indicated アルツハイマー病による軽度認知障害及び軽度の認知症患者におけるドナネマブ(遺伝子組換え)の適切な投与の補助 | New active ingredient standard | 2020-05-28 | 2024-08-22 | 1,674 d 4.6 y | 127 d 0.3 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Ryjusea Mini リジュセアミニ | Atropine sulfate hydrate アトロピン硫酸塩水和物 | Santen Pharmaceutical Co., Ltd. 参天製薬(株) | Slowing the progression of myopia 近視の進行抑制 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Randa ランダ | Cisplatin シスプラチン | Nippon Kayaku Co., Ltd. 日本化薬(株) | Treatment of urothelial carcinoma 尿路上皮癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Qalsody クアルソディ髄 | Tofersen トフェルセン | Biogen Japan Ltd. バイオジェン・ジャパン(株) | Slowing the progression of functional impairment in patients with amyotrophic lateral sclerosis with SOD1 mutation SOD1遺伝子変異を有する筋萎縮性側索硬化症における機能障害の進行抑制 | New active ingredient orphanpriority | 2023-04-25 | 2024-05-29 | 612 d 1.7 y | 212 d 0.6 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Opdivo オプジーボ | Nivolumab ニボルマブ(遺伝子組換え) | Ono Pharmaceutical Co., Ltd. 小野薬品工業(株) | Treatment of unresectable urothelial carcinoma 根治切除不能な尿路上皮癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Oldamin オルダミン | Monoethanolamine oleate モノエタノールアミンオレイン酸塩 | Fuji Chemical Industries Co., Ltd. 富士化学工業(株) | Use in sclerotherapy of venous malformation 静脈奇形の硬化退縮 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Lunsumio ルンスミオ | Mosunetuzumab モスネツズマブ(遺伝子組換え) | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of relapsed or refractory follicular lymphoma 再発又は難治性の濾胞性リンパ腫 | New active ingredient standard | 2022-12-22 | 2022-06-03 | 736 d 2.0 y | 938 d 2.6 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Keytruda キイトルーダ | Pembrolizumab ペムブロリズマブ(遺伝子組換え) Orphan | MSD K.K. MSD(株) | Treatment of advanced or recurrent endometrial cancer 進行・再発の子宮体癌 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Kavigale カビゲイル | Sipavibart シパビバルト(遺伝子組換え) | AstraZeneca K.K. アストラゼネカ(株) | Prevention of disease caused by SARS-CoV-2 infection (COVID-19) SARS-CoV-2による感染症の発症抑制 | New active ingredient standard | — | 2025-01-20 | — | 24 d earlier Japan first | [1] [2] [3] [4] |
| 2024-12-27 | Imdelltra イムデトラ | Tarlatamab タルラタマブ(遺伝子組換え) Orphan | Amgen K.K. アムジェン(株) | Treatment of small cell lung cancer that has progressed after cancer chemotherapy がん化学療法後に増悪した小細胞肺癌 | New active ingredient orphanpriority | 2024-05-16 | 2026-05-29 | 225 d 0.6 y | 518 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2024-12-27 | Hympavzi S.C. ヒムペブジ | Marstacimab マルスタシマブ(遺伝子組換え) | Pfizer Japan Inc. ファイザー(株) | Control of bleeding tendency in patients with congenital haemophilia who do not have inhibitors against blood coagulation factor VIII or IX 血液凝固第VIII因子又は第IX因子に対するインヒビターを保有しない先天性血友病患者における出血傾向の抑制 | New active ingredient standard | 2024-10-11 | 2024-11-18 | 77 d 0.2 y | 39 d 0.1 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | HyQvia ハイキュービア | Human normal immunoglobulin G (pH4-treated acidic normal human immunoglobulin [subcutaneous injection]) and Vorhyaluronidase alfa 人免疫グロブリンG及びボルヒアルロニダーゼ アルファ(遺伝子組換え) | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Treatment of agammaglobulinemia or hypogammaglobulinemia 無又は低ガンマグロブリン血症 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Fasenra ファセンラ | Benralizumab ベンラリズマブ(遺伝子組換え) | AstraZeneca K.K. アストラゼネカ(株) | Treatment of eosinophilic granulomatosis with polyangiitis in patients who have not responded sufficiently to conventional therapies 既存治療で効果不十分な好酸球性多発血管炎性肉芽腫症 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Efluelda エフルエルダ | Influenza virus (type A and type B) HA fraction インフルエンザウイルス(A型・B型)HA画分 | Sanofi K.K. サノフィ(株) | Prevention of influenza インフルエンザの予防 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2024-12-27 | Datroway ダトロウェイ | Datopotamab deruxtecan ダトポタマブ デルクステカン(遺伝子組換え) | Daiichi Sankyo Company, Limited 第一三共(株) | Treatment of hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative unresectable or recurrent breast cancer in patients who have previously been treated with chemotherapy 化学療法歴のあるホルモン受容体陽性かつHER2陰性の手術不能又は再発乳癌 | New active ingredient standard | 2025-01-17 | 2025-04-04 | 21 d earlier Japan first | 98 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2024-12-27 | Calquence カルケンス | Acalabrutinib maleate hydrate アカラブルチニブマレイン酸塩水和物 | AstraZeneca K.K. アストラゼネカ(株) | Treatment of chronic lymphocytic leukemia (including small lymphocytic lymphoma) 慢性リンパ性白血病(小リンパ球性リンパ腫を含む) | New active ingredient standard | 2017-10-31 | 2020-11-05 | 2,614 d 7.2 y | 1,513 d 4.1 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Brukinsa ブルキンザ | Zanubrutinib ザヌブルチニブ | BeiGene Japan GK. BeiGene Japan(同) | Treatment of chronic lymphocytic leukemia (including small lymphocytic lymphoma), Waldenström's macroglobulinemia, and lymphoplasmacytic lymphoma 慢性リンパ性白血病(小リンパ球性リンパ腫を含む)および原発性マクログロブリン血症及びリンパ形質細胞リンパ腫 | New active ingredient standard | 2019-11-14 | 2021-11-22 | 1,870 d 5.1 y | 1,131 d 3.1 y | [1] [2] [3] [4] [5] |
| 2024-12-27 | Balversa バルバーサ | Erdafitinib エルダフィチニブ | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of unresectable urothelial carcinoma with FGFR3 gene mutation or fusion gene that has progressed after cancer chemotherapy がん化学療法後に増悪したFGFR3遺伝子変異又は融合遺伝子を有する根治切除不能な尿路上皮癌 | New active ingredient standard | 2019-04-12 | 2024-08-22 | 2,086 d 5.7 y | 127 d 0.3 y | [1] [2] [3] [4] [5] |
Click a column header to sort. Lag = days between the FDA (or EMA) approval and the Japanese approval of the same active ingredient; “Japan first” means Japan approved it earlier. Lag is shown only when a matching foreign approval was found. JP = no English name found; Japanese kept.
Source: PMDA / MHLW (PDL1.0). Unofficial English translation, edited by Japan Pharma Regulatory Brief.
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