PMDA · MHLW · monthly list
All drugs approved in Japan in August 2025, in English.
Last updated: 2026-10-02 · 13 approvals
Japan approved 13 drugs in August 2025 (approval dates: 2025-08-08, 2025-08-25): 6 new indication, 4 new active ingredient, 1 new dosage form, 1 new dosage, 1 other. Median lag vs FDA for this month: 1.0 years (381 days) (n=1).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-08-25 | Yorvipath ヨビパス | Palopegteriparatide パロペグテリパラチド | Teijin Pharma Limited 帝人ファーマ(株) | Treatment of hypoparathyroidism 副甲状腺機能低下症 | New active ingredient orphanpriority | 2024-08-09 | 2023-11-17 | 381 d 1.0 y | 647 d 1.8 y | [1] [2] [3] [4] [5] |
| 2025-08-25 | Yervoy ヤーボイ | Ipilimumab イピリムマブ(遺伝子組換え) Orphan | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Treatment of unresectable, advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer 治癒切除不能な進行・再発の高頻度マイクロサテライト不安定性(MSI-High)を有する結腸・直腸癌 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Vorzzz ボルズィ | Vornorexant hydrate ボルノレキサント水和物 | Taisho Pharmaceutical Co., Ltd. 大正製薬(株) | Treatment of insomnia 不眠症 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Silgard シルガード | Recombinant adsorbed 9-valent human papillomavirus virus-like particle vaccines (yeast origin) 組換え沈降9価ヒトパピローマウイルス様粒子ワクチン(酵母由来) | MSD K.K. MSD(株) | Prevention of the following diseases caused by infection with human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, and 58: ・Anal cancer (squamous cell carcinoma) and its precursor lesions (anal intraepithelial neoplasia 1, 2, and 3) ヒトパピローマウイルス6、11、16、18、31、33、45、52及び58型の感染に起因する以下の疾患の予防 ・肛門癌(扁平上皮癌)及びその前駆病変(肛門上皮内腫瘍(AIN)1、2及び3) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Setaneo セタネオ | Sepetaprost セペタプロスト | Santen Pharmaceutical Co., Ltd. 参天製薬(株) | Treatment of glaucoma and ocular hypertension 緑内障、高眼圧症 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Opdivo オプジーボ | Nivolumab ニボルマブ(遺伝子組換え) Orphan | Ono Pharmaceutical Co., Ltd. 小野薬品工業(株) | Treatment of unresectable, advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer 治癒切除不能な進行・再発の高頻度マイクロサテライト不安定性(MSI-High)を有する結腸・直腸癌 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Magmitt マグミット | Magnesium oxide 酸化マグネシウム | Magmitt Pharmaceutical Co., Ltd. マグミット製薬(株) | Treatment of constipation. (2) (3) (4) (5) (6) Drugs with a new pediatric dosage indicated for the treatment of constipation 便秘症 | New dosage form standard | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | 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 神経線維腫症1型における叢状神経線維腫 | New dosage orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Kisunla ケサンラ | Donanemab ドナネマブ(遺伝子組換え) | Eli Lilly Japan K.K. 日本イーライリリー(株) | Slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease 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の進行抑制 | Other standard | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Enhertu エンハーツ | Trastuzumab deruxtecan トラスツズマブ 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)-low or -ultralow inoperable or recurrent breast cancer ホルモン受容体陽性かつHER2低発現又は超低発現の手術不能又は再発乳癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | Doptelet ドプテレット | Avatrombopag maleate アバトロンボパグマレイン酸塩 | Swedish Orphan Biovitrum Japan Co., Ltd. Swedish Orphan Biovitrum Japan(株) | Treatment of persistent and chronic immune thrombocytopenia 持続性及び慢性免疫性血小板減少症 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-08-25 | 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 mantle cell lymphoma マントル細胞リンパ腫 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-08-08 | Capvaxive キャップバックス | Pneumococcal 21-valent conjugate vaccine (mutated diphtheria CRM197 conjugate) 21価肺炎球菌結合型ワクチン(無毒性変異ジフテリア毒素結合体) | MSD K.K. MSD(株) | Prophylaxis of pneumococcal disease in the elderly or in adults who are considered to be at a high risk of pneumococcal disease 高齢者又は肺炎球菌による疾患に罹患するリスクが高いと考えられる成人における肺炎球菌による感染症の予防 | New active ingredient 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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