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All drugs approved in Japan in June 2025, in English.
Last updated: 2026-10-02 · 19 approvals
Japan approved 19 drugs in June 2025 (approval date: 2025-06-24): 9 new indication, 6 new active ingredient, 2 new route, 1 new dosage form, 1 new dosage. Median lag vs FDA for this month: 1.8 years (660 days) (n=6).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-06-24 | Yervoy ヤーボイ | Ipilimumab イピリムマブ(遺伝子組換え) | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Treatment of unresectable hepatocellular carcinoma 切除不能な肝細胞癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Xeomin ゼオマイン | Incobotulinumtoxin A インコボツリヌストキシンA | Teijin Pharma Limited 帝人ファーマ(株) | Treatment of chronic sialorrhea 慢性流涎 | New route standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Welireg ウェリレグ | Belzutifan ベルズチファン Orphan | MSD K.K. MSD(株) | Treatment of unresectable or metastatic renal cell carcinoma that has progressed after cancer chemotherapy. (2) A drug with a new active ingredient indicated for the treatment of von Hippel-Lindau disease-associated tumors. )] (1) がん化学療法後に増悪した根治切除不能又は転移性の腎細胞癌 (2) フォン・ヒッペル・リンドウ病関連腫瘍 | New active ingredient orphanpriority | 2021-08-13 | 2025-02-12 | 1,411 d 3.9 y | 132 d 0.4 y | [1] [2] [3] [4] [5] |
| 2025-06-24 | Velsipity ベルスピティ | Etrasimod L-arginine エトラシモド L-アルギニン | Pfizer Japan Inc. ファイザー(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 | 2023-10-12 | 2024-02-16 | 621 d 1.7 y | 494 d 1.4 y | [1] [2] [3] [4] [5] |
| 2025-06-24 | Tremfya トレムフィア | Guselkumab グセルクマブ(遺伝子組換え) | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments) 中等症から重症の活動期クローン病の治療(既存治療で効果不十分な場合に限る) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Talvey タービー | Talquetamab トアルクエタマブ(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 | 2023-08-09 | 2023-08-21 | 685 d 1.9 y | 673 d 1.8 y | [1] [2] [3] [4] [5] |
| 2025-06-24 | Spydia スピジア | Diazepam ジアゼパム Orphan | Aculys Pharma, Inc. アキュリスファーマ(株) | Treatment of status epilepticus てんかん重積状態 | New route orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Rinvoq リンヴォック | Upadacitinib hydrate ウパダシチニブ水和物 | AbbVie GK アッヴィ(同) | Treatment of giant cell arteritis in patients who have not responded sufficiently to conventional treatments 既存治療で効果不十分な巨細胞性動脈炎 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Pombiliti ポムビリティ | Cipaglucosidase alfa シパグルコシダーゼ アルファ(遺伝子組換え) | Amicus Therapeutics, Inc. アミカス・セラピューティクス(株) | Use as a combination therapy with miglustat for the treatment of late-onset Pompe disease (LOPD) 遅発型ポンペ病に対するミグルスタットとの併用療法 | New active ingredient orphanpriority | 2023-09-28 | 2023-03-20 | 635 d 1.7 y | 827 d 2.3 y | [1] [2] [3] [4] [5] |
| 2025-06-24 | Opfolda オプフォルダ | Miglustat ミグルスタット Orphan | Amicus Therapeutics, Inc. アミカス・セラピューティクス(株) | Use as a combination therapy with cipaglucosidase alfa (genetical recombination) for the treatment of late-onset Pompe disease (LOPD) 遅発型ポンペ病に対するシパグルコシダーゼ アルファ(遺伝子組換え)との併用療法 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | 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 hepatocellular carcinoma 切除不能な肝細胞癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Nesp ネスプ | Darbepoetin alfa ダルベポエチン アルファ(遺伝子組換え) | [1] Kyowa Kirin Co., Ltd., [2] Kyowa Kirin Frontier Co., Ltd. 協和キリン(株); 協和キリンフロンティア(株) | Treatment of anemia resulting from the administration of belzutifan ベルズチファン投与に伴う貧血 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Lialda Tab. リアルダ | Mesalazine メサラジン | Mochida Pharmaceutical Co., Ltd. 持田製薬(株) | Treatment of ulcerative colitis (excluding severe cases). (2) A drug with a new dosage indicated for the treatment of ulcerative colitis (excluding severe cases) 潰瘍性大腸炎(重症を除く) | New dosage form standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Inrebic インレビック | Fedratinib hydrochloride hydrate フェドラチニブ塩酸塩水和物 Orphan | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Treatment of myelofibrosis 骨髄線維症 | New active ingredient orphanpriority | 2019-08-16 | 2021-02-08 | 2,139 d 5.9 y | 1,597 d 4.4 y | [1] [2] [3] [4] [5] |
| 2025-06-24 | HyQvia ハイキュービア | pH4-treated acidic normal human immunoglobulin (subcutaneous injection) and Vorhyaluronidase alfa pH4処理酸性人免疫グロブリン(皮下注射)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) | Inhibiting progression of motor disability due to chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy (in the cases where patients show an improvement in their acute phase treatment) 慢性炎症性脱髄性多発根神経炎及び多巣性運動ニューロパチーの運動機能低下の進行抑制(筋力低下の改善が認められた場合) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Elrexfio S.C. エルレフィオ | Elranatamab エルラナタマブ(遺伝子組換え) Orphan | Pfizer Japan Inc. ファイザー(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 dosage orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Anerem アネレム | Remimazolam besilate レミマゾラムベシル酸塩 | Mundipharma K.K. ムンディファーマ(株) | Sedation during gastrointestinal endoscopy. (2) A drug with a new indication, a new dosage, and other characteristics for sedation during gastrointestinal endoscopy 消化器内視鏡診療時の鎮静 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Amvuttra アムヴトラ | Vutrisiran sodium ブトリシランナトリウム Orphan | Alnylam Japan, K.K. Alnylam Japan(株) | Treatment of transthyretin cardiac amyloidosis (wild-type and hereditary) トランスサイレチン型心アミロイドーシス(野生型及び変異型) | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-06-24 | Airwin エアウィン | Sotatercept ソタテルセプト(遺伝子組換え) | MSD K.K. MSD(株) | Treatment of pulmonary arterial hypertension 肺動脈性肺高血圧症 | New active ingredient orphanpriority | 2024-03-26 | 2024-08-22 | 455 d 1.2 y | 306 d 0.8 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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