PMDA · MHLW · monthly list
All drugs approved in Japan in September 2025, in English.
Last updated: 2026-10-02 · 33 approvals
Japan approved 33 drugs in September 2025 (approval date: 2025-09-19): 12 new active ingredient, 9 new indication, 5 biosimilar, 3 new dosage, 2 new dosage form, 2 new route. Median lag vs FDA for this month: 2.2 years (791 days) (n=11).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-09-19 | Ycanth ワイキャンス | Cantharidin カンタリジン | Torii Pharmaceutical Co., Ltd. 鳥居薬品(株) | Treatment of molluscum contagiosum 伝染性軟属腫 | New active ingredient standard | 2023-07-21 | — | 791 d 2.2 y | — | [1] [2] [3] [4] |
| 2025-09-19 | Xofluza ゾフルーザ | Baloxavir marboxil バロキサビル マルボキシル | Shionogi & Co., Ltd. 塩野義製薬(株) | Treatment of influenza A or B virus infection A型又はB型インフルエンザウイルス感染症の治療及びその予防 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Voranigo ボラニゴ | Vorasidenib citric acid hydrate ボラシデニブ クエン酸水和物 Orphan | Nihon Servier Co., Ltd. 日本セルヴィエ(株) | Treatment of IDH1 or IDH2 gene mutation-positive glioma IDH1又はIDH2遺伝子変異陽性の神経膠腫 | New active ingredient orphanpriority | 2024-08-06 | 2025-09-17 | 409 d 1.1 y | 2 d 0.0 y | [1] [2] [3] [4] [5] |
| 2025-09-19 | Vectibix ベクティビックス | Panitumumab パニツムマブ(遺伝子組換え) | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Treatment of unresectable advanced or recurrent KRAS G12C mutation-positive colorectal cancer that has progressed after cancer chemotherapy がん化学療法後に増悪したKRAS G12C変異陽性の治癒切除不能な進行・再発の結腸・直腸癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Tocilizumab BS トシリズマブBS | Tocilizumab [tocilizumab biosimilar 1] トシリズマブ(遺伝子組換え)[トシリズマブ後続1] | Celltrion Healthcare Japan K.K. セルトリオン・ヘルスケア・ジャパン(株) | Biosimilars indicated for the following diseases: ・The treatment of rheumatoid arthritis (including the prevention of structural joint damage), polyarticular-course juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, in patients who have not sufficiently responded to conventional treatments. ・The improvement of various symptoms and laboratory findings associated with Castleman's disease for whom resection of lymph nodes is not indicated. ・The treatment of cytokine release syndrome induced by the treatment of malignant tumor. (4) (5) Biosimilars indicated for the following disease： ・The treatment of rheumatoid arthritis (including the prevention of structural joint damage) in patients who have not sufficiently responded to conventional treatments (1) (2) (3) ○既存治療で効果不十分な下記疾患 関節リウマチ(関節の構造的損傷の防止を含む)、多関節に活動性を有する若年性特発性関節炎、全身型若年性特発性関節炎 ○キャッスルマン病に伴う諸症状及び検査所見(C反応性タンパク高値、フィブリノーゲン高値、赤血球沈降速度亢進、ヘモグロビン低値、アルブミン低値、全身倦怠感)の改善。ただし、リンパ節の摘除が適応とならない患者に限る。 ○悪性腫瘍治療に伴うサイトカイン放出症候群 (4) (5) 既存治療で効果不十分な下記疾患 ○関節リウマチ(関節の構造的損傷の防止を含む) | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Tecentriq テセントリク | Atezolizumab アテゾリズマブ(遺伝子組換え) | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of following diseases: ・Unresectable advanced or recurrent non-small cell lung cancer ・Postoperative adjuvant treatment for PD-L1 positive non-small cell lung cancer ・PD-L1 positive, hormone receptor (HR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative inoperable or recurrent breast cancer ・Extensive-stage small-cell lung cancer ○切除不能な進行・再発の非小細胞肺癌 ○PD-L1陽性の非小細胞肺癌における術後補助療法 ○PD-L1陽性のホルモン受容体陰性かつHER2陰性の手術不能又は再発乳癌 ○進展型小細胞肺癌 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Tecentriq テセントリク | Atezolizumab アテゾリズマブ(遺伝子組換え) | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of relapsed or refractory extranodal NK/T-cell lymphoma, nasal type 再発又は難治性の節外性NK/T細胞リンパ腫・鼻型 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Spinraza スピンラザ髄 | Nusinersen sodium ヌシネルセンナトリウム Orphan | Biogen Japan Ltd. バイオジェン・ジャパン(株) | Treatment of spinal muscular atrophy 脊髄性筋萎縮症 | New dosage form orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Raiatt MIBG-I ライアットMIBG-I | 3-Iodobenzylguanidine (131I) 3‐ヨードベンジルグアニジン(131I) | PDRadiopharma Inc. PDRファーマ(株) | Treatment of MIBG-positive neuroblastoma MIBG集積陽性の神経芽腫 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Pluvicto プルヴィクト | Lutetium (177Lu) vipivotide tetraxetan ルテチウムビピボチドテトラキセタン(177Lu) | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of PSMA-positive, metastatic castration-resistant prostate cancer PSMA 陽性の遠隔転移を有する去勢抵抗性前立腺癌 | New active ingredient standard | 2022-03-23 | 2022-12-09 | 1,276 d 3.5 y | 1,015 d 2.8 y | [1] [2] [3] [4] [5] |
| 2025-09-19 | Nurtec ナルティークOD | Rimegepant sulfate hydrate リメゲパント硫酸塩水和物 | Pfizer Japan Inc. ファイザー(株) | Acute treatment and prevention of migraine attacks 片頭痛発作の急性期治療及び発症抑制 | New active ingredient standard | 2020-02-27 | 2022-04-25 | 2,031 d 5.6 y | 1,243 d 3.4 y | [1] [2] [3] [4] [5] |
| 2025-09-19 | Nexletol ネクセトール | Bempedoic acid ベムペド酸 | Otsuka Pharmaceutical Co., Ltd. 大塚製薬(株) | Treatment of hypercholesterolemia and familial hypercholesterolemia 高コレステロール血症、家族性高コレステロール血症 | New active ingredient standard | 2020-02-21 | 2020-04-01 | 2,037 d 5.6 y | 1,997 d 5.5 y | [1] [2] [3] [4] [5] |
| 2025-09-19 | Neffy ネフィー | Adrenaline アドレナリン | Alfresa Pharma Corporation アルフレッサ ファーマ(株) | Adjunctive treatment for anaphylactic reactions caused by bee venom, foods, drugs, and others (for use only in individuals with a history of anaphylaxis or at a high risk of anaphylaxis) 蜂毒、食物及び薬物等に起因するアナフィラキシー反応に対する補助治療(アナフィラキシーの既往のある人またはアナフィラキシーを発現する危険性の高い人に限る) | New route standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Lumakras ルマケラス | Sotorasib ソトラシブ | Amgen K.K. アムジェン(株) | Treatment of unresectable advanced or recurrent KRAS G12C mutation-positive colorectal cancer that has progressed after cancer chemotherapy がん化学療法後に増悪したKRAS G12C変異陽性の治癒切除不能な進行・再発の結腸・直腸癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Locametz ロカメッツ | Gozetotide ゴゼトチド | Novartis Pharma K.K. ノバルティスファーマ(株) | Support of selection of patients with prostate cancer, for whom PSMA-targeted therapy is indicated PSMA 標的療法の前立腺癌患者への適応判定の補助 | New active ingredient standard | — | 2022-12-09 | — | 1,015 d 2.8 y | [1] [2] [3] [4] |
| 2025-09-19 | Libtayo I.V. リブタヨ | Cemiplimab セミプリマブ(遺伝子組換え) | Regeneron Japan KK リジェネロン・ジャパン(株) | Treatment of unresectable advanced or recurrent non-small-cell lung cancer 切除不能な進行・再発の非小細胞肺癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Koselugo コセルゴ | Selmetinib sulfate セルメチニブ硫酸塩 Orphan | Alexion Pharma GK アレクシオンファーマ(同) | Treatment of plexiform neurofibroma in patients with neurofibromatosis type 1. (3) (4) Drugs with a new dosage indicated for the treatment of plexiform neurofibroma in patients with neurofibromatosis type 1 神経線維腫症1型における叢状神経線維腫 | New dosage form orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Jivi ジビイ | Damoctocog alfa pegol ダモクトコグ アルファ ペゴル(遺伝子組換え) | Bayer Yakuhin, Ltd. バイエル薬品(株) | Control of bleeding tendency in patients with blood coagulation factor VIII deficiency 血液凝固第VIII因子欠乏患者における出血傾向の抑制 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Jaypirca ジャイパーカ | Pirtobrutinib ピルトブルチニブ | Eli Lilly Japan K.K. 日本イーライリリー(株) | Treatment of relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) with resistant or intolerant to other BTK inhibitors 他のBTK阻害剤に抵抗性又は不耐容の再発又は難治性の慢性リンパ性白血病(小リンパ球性リンパ腫を含む) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Izervay アイザベイ硝子体内 | Avacincaptad pegol sodium アバシンカプタド ペゴルナトリウム Conditional | Astellas Pharma Inc. アステラス製薬(株) | Slowing the progression of geographic atrophy secondary to age-related macular degeneration 萎縮型加齢黄斑変性における地図状萎縮の進行抑制 | New active ingredient standardconditional | 2023-08-04 | — | 777 d 2.1 y | — | [1] [2] [3] [4] |
| 2025-09-19 | Imfinzi イミフィンジ | Durvalumab デュルバルマブ(遺伝子組換え) | AstraZeneca K.K. アストラゼネカ(株) | Preoperative and postoperative adjuvant treatment for non-small cell lung cancer and preoperative and postoperative adjuvant treatment for bladder cancer ○非小細胞肺癌における術前・術後補助療法 ○膀胱癌における術前・術後補助療法 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Imaavy アイマービー | Nipocalimab ニポカリマブ(遺伝子組換え) Orphan | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of generalized myasthenia gravis (for use only in patients who have not sufficiently responded to steroids or other immunosuppressants) 全身型重症筋無力症(ステロイド剤又はステロイド剤以外の免疫抑制剤が十分に奏効しない場合に限る) | New active ingredient orphanpriority | 2025-04-29 | 2025-11-28 | 143 d 0.4 y | 70 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2025-09-19 | Ibtrozi イブトロジー | Taletrectinib adipate タレトレクチニブアジピン酸塩 | Nippon Kayaku Co., Ltd. 日本化薬(株) | Treatment of ROS1 fusion gene-positive unresectable advanced or recurrent non-small-cell lung cancer ROS1融合遺伝子陽性の切除不能な進行・再発の非小細胞肺癌 | New active ingredient orphanpriority | 2025-06-11 | — | 100 d 0.3 y | — | [1] [2] [3] [4] |
| 2025-09-19 | Hernexeos ヘルネクシオス | Zongertinib ゾンゲルチニブ Orphan | Nippon Boehringer Ingelheim Co., Ltd. 日本ベーリンガーインゲルハイム(株) | Treatment of unresectable advanced or recurrent HER2 (ERBB2) mutation-positive non-small cell lung cancer that has progressed after cancer chemotherapy がん化学療法後に増悪したHER2(ERBB2)遺伝子変異陽性の切除不能な進行・再発の非小細胞肺癌 | New active ingredient orphanpriority | 2025-08-08 | — | 42 d 0.1 y | — | [1] [2] [3] [4] |
| 2025-09-19 | Golimumab BS ゴリムマブBS | Golimumab [golimumab biosimilar 1] ゴリムマブ(遺伝子組換え)[ゴリムマブ後続1] | Fuji Pharma Co., Ltd. 富士製薬工業(株) | A biosimilar indicated for the treatment of rheumatoid arthritis (including the prevention of structural joint damage) in patients who have not sufficiently responded to conventional treatments 既存治療で効果不十分な関節リウマチ(関節の構造的損傷の防止を含む) | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | GalliaPharm ガリアファーム | Gallium (68Ga) chloride 塩化ガリウム(68Ga) | Eckert & Ziegler Radiopharma GmbH | Gallium (68Ga) radiolabelling of radiopharmaceutical precursors approved for positron emission tomography (PET) imaging 陽電子放出断層撮影(PET)イメージングのために承認された被標識用製剤のガリウム(68Ga)標識 | New active ingredient standard | 1976-05-17 | — | 18,022 d 49.3 y | — | [1] [2] [3] [4] |
| 2025-09-19 | Fujichenon Granular フジケノン粒状 | Chenodeoxycholic acid ケノデオキシコール酸 Orphan | Fujimoto Pharmaceutical Corporation 藤本製薬(株) | Treatment of cerebrotendinous xanthomatosis 脳腱黄色腫症 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Dormicum ドルミカム | Midazolam ミダゾラム | Maruishi Pharmaceutical Co., Ltd. 丸石製薬(株) | Anesthetic premedication 麻酔前投薬 | New route standardspecific-use | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Denosumab BS デノスマブBS | Denosumab [denosumab biosimilar 1] デノスマブ(遺伝子組換え)[デノスマブ後続1] | Fuji Pharma Co., Ltd. 富士製薬工業(株) | A biosimilar indicated for the treatment of bone lesions due to multiple myeloma and bone metastasis of solid tumor 多発性骨髄腫による骨病変及び固形癌骨転移による骨病変 | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Cellcept セルセプト | Mycophenolate mofetil ミコフェノール酸 モフェチル | [1] [2] Chugai Pharmaceutical Co., Ltd., [3] Viatris Healthcare G.K. 中外製薬(株); ヴィアトリス・ヘルスケア(同) | Treatment of refractory nephrotic syndrome (for use frequent relapsing or steroid-dependent nephrotic syndrome) 難治性のネフローゼ症候群(頻回再発型あるいはステロイド依存性を示す場合) | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Bylvay ビルベイ | Odevixibat hydrate オデビキシバット水和物 | Ipsen Co., Ltd. IPSEN(株) | Treatment of pruritus in patients with progressive familial intrahepatic cholestasis 進行性家族性肝内胆汁うっ滞症に伴うそう痒 | New active ingredient orphanpriority | 2021-07-20 | 2021-07-16 | 1,522 d 4.2 y | 1,526 d 4.2 y | [1] [2] [3] [4] [5] |
| 2025-09-19 | Aflibercept BS アフリベルセプトBS硝子体内 | Aflibercept [aflibercept biosimilar 2] アフリベルセプト(遺伝子組換え)[アフリベルセプト後続2] | Fuji Pharma Co., Ltd. 富士製薬工業(株) | Biosimilars indicated for the treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization, macular edema following retinal vein occlusion, and choroidal neovascularization in patients with pathologic myopia ○中心窩下脈絡膜新生血管を伴う加齢黄斑変性 ○網膜静脈閉塞症に伴う黄斑浮腫 ○病的近視における脈絡膜新生血管 | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2025-09-19 | Aflibercept BS アフリベルセプトBS硝子体内 | Aflibercept [aflibercept biosimilar 3] アフリベルセプト(遺伝子組換え)[アフリベルセプト後続3] | SamChunDang Pharm. Co., Ltd. | Biosimilars indicated for the treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization, macular edema following retinal vein occlusion, and choroidal neovascularization in patients with pathologic myopia ○中心窩下脈絡膜新生血管を伴う加齢黄斑変性 ○網膜静脈閉塞症に伴う黄斑浮腫 ○病的近視における脈絡膜新生血管 | Biosimilar standard | — | — | — | — | [1] [2] [3] |
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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