PMDA · MHLW · monthly list
All drugs approved in Japan in November 2025, in English.
Last updated: 2026-10-02 · 7 approvals
Japan approved 7 drugs in November 2025 (approval date: 2025-11-20): 6 new indication, 1 new dosage.
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-11-20 | Venclexta ベネクレクスタ | Venetoclax ベネトクラクス | AbbVie GK アッヴィ(同) | 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 indication standard | — | — | — | — | [1] [2] [3] |
| 2025-11-20 | Uplizna ユプリズナ | Inebilizumab イネビリズマブ(遺伝子組換え) Orphan | Tanabe Pharma Corporation 田辺三菱製薬(株) | Prevention of relapse of IgG4 related disease IgG4関連疾患の再燃抑制 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-11-20 | Darzquro ダラキューロ | Daratumumab/ Vorhyaluronidase alfa ダラツムマブ(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) | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Delaying the progression of high-risk smoldering multiple myeloma 高リスクのくすぶり型多発性骨髄腫における進展遅延 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-11-20 | Braftovi ビラフトビ | Encorafenib エンコラフェニブ Orphan | Ono Pharmaceutical Co., Ltd. 小野薬品工業(株) | Treatment of unresectable, advanced or recurrent BRAF mutation-positive colorectal cancer BRAF遺伝子変異を有する治癒切除不能な進行・再発の結腸・直腸癌 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-11-20 | Beovu ベオビュ硝子体内 | Brolucizumab ブロルシズマブ(遺伝子組換え) | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization and proliferative diabetic retinopathy 〇中心窩下脈絡膜新生血管を伴う加齢黄斑変性 ○増殖糖尿病網膜症 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-11-20 | Augtyro オータイロ | Repotrectinib レポトレクチニブ Orphan | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Treatment of NTRK fusion gene-positive advanced or recurrent solid tumors NTRK融合遺伝子陽性の進行・再発の固形癌 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-11-20 | Anaemetro アネメトロ | Metronidazole メトロニダゾール | Pfizer Japan Inc. ファイザー(株) | Treatment of anaerobic infection (sepsis, deep skin infection, secondary infections of traumas/burns and surgical wounds, osteomyelitis, pneumonia, lung abscess, empyema, pelvic inflammatory disease, peritonitis, intra-abdominal abscess, cholecystitis, liver abscess, purulent meningitis, and brain abscess caused by Metronidazole-sensitive Peptostreptococcus spp., Bacteroides spp., Prevotella spp., Porphyromonas spp., Fusobacterium spp., Clostridium spp., and Eubacterium spp.), infectious enteritis (Infectious enteritis caused by Metronidazole-sensitive Clostridium difficile), and amoebic dysentery ○嫌気性菌感染症 <適応菌種> 本剤に感性のペプトストレプトコッカス属、バクテロイデス属、プレボテラ属、ポルフィロモナス属、フソバクテリウム属、クロストリジウム属、ユーバクテリウム属 <適応症> ・敗血症 ・深在性皮膚感染症 ・外傷・熱傷及び手術創等の二次感染 ・骨髄炎 ・肺炎、肺膿瘍、膿胸 ・骨盤内炎症性疾患 ・腹膜炎、腹腔内膿瘍 ・胆嚢炎、肝膿瘍 ・化膿性髄膜炎 ・脳膿瘍 ○感染性腸炎 <適応菌種> 本剤に感性のクロストリジウム・ディフィシル <適応症> 感染性腸炎(偽膜性大腸炎を含む) ○アメーバ赤痢 | New dosage standardpublic-knowledge | — | — | — | — | [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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