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All drugs approved in Japan in May 2026, in English.
Last updated: 2026-10-02 · 10 approvals
Japan approved 10 drugs in May 2026 (approval dates: 2026-05-11, 2026-05-18): 6 new indication, 3 new active ingredient, 1 new dosage. Median lag vs FDA for this month: 0.6 years (223 days) (n=1).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2026-05-18 | ジャスケイド JP | nerandomilast ネランドミラスト Orphan | Nippon Boehringer Ingelheim Co., Ltd. 日本ベーリンガーインゲルハイム(株) | Idiopathic pulmonary fibrosis; Progressive pulmonary fibrosis 特発性肺線維症 進行性肺線維症 | New active ingredient orphanpriority | 2025-10-07 | 2026-07-15 | 223 d 0.6 y | 58 d earlier Japan first | [1] [2] [3] [4] |
| 2026-05-18 | エムネクスパイク JP | mRNA encoding the N-terminal region and receptor-binding domain of the SARS-CoV-2 spike protein SARS-CoV-2のスパイクタンパク質のN-末端部位及び受容体結合部位をコードするmRNA | Moderna Japan Co., Ltd. モデルナ・ジャパン(株) | Prevention of infection caused by SARS-CoV-2 SARS-CoV-2による感染症の予防 | New active ingredient standard | — | — | — | — | [1] [2] |
| 2026-05-18 | 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) | Obesity: limited to cases where the patient has at least one of hypertension, dyslipidemia, or impaired glucose tolerance (type 2 diabetes mellitus, impaired glucose tolerance, etc.), and adequate efficacy is not obtained despite dietary and exercise therapy, and meets one of the following criteria: • BMI ≥27 kg/m² and has two or more obesity-related health disorders • BMI ≥35 kg/m² 肥満症 ただし、高血圧、脂質異常症又は耐糖能障害(2型糖尿病、耐糖能異常等)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] |
| 2026-05-18 | 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) | Obstructive sleep apnea syndrome of moderate severity or higher: limited to cases where BMI ≥27 kg/m² 中等症以上の閉塞性睡眠時無呼吸症候群 ただし、BMIが27 kg/m2以上に該当する場合に限る。 | New indication standard | — | — | — | — | [1] [2] |
| 2026-05-18 | Sotyktu ソーティクツ | Deucravacitinib デュークラバシチニブ | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Psoriatic arthritis for which existing treatment is inadequate 既存治療で効果不十分な下記疾患 ○乾癬性関節炎 | New indication standard | — | — | — | — | [1] [2] |
| 2026-05-18 | MabCampath I.V. マブキャンパス | Alemtuzumab アレムツズマブ(遺伝子組換え) | Sanofi K.K. サノフィ(株) | T-cell prolymphocytic leukemia T細胞性前リンパ球性白血病 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] |
| 2026-05-18 | Fasenra ファセンラ | Benralizumab ベンラリズマブ(遺伝子組換え) Orphan | AstraZeneca K.K. アストラゼネカ(株) | Hypereosinophilic syndrome 好酸球増多症候群 | New indication orphanpriority | — | — | — | — | [1] [2] |
| 2026-05-18 | Arexvy アレックスビー | Recombinant respiratory syncytial virus PreF3 antigen RSウイルスPreF3抗原 | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Prevention of infection caused by Respiratory Syncytial Virus RSウイルスによる感染症の予防 | New dosage standard | — | — | — | — | [1] [2] |
| 2026-05-18 | Alecensa アレセンサ | Alectinib hydrochloride アレクチニブ塩酸塩 | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Solid tumors with ALK fusion genes that are advanced or recurrent ALK 融合遺伝子陽性の進行・再発の固形癌 | New indication standard | — | — | — | — | [1] [2] |
| 2026-05-11 | ミムリット JP | live attenuated measles virus (AIK-C strain), live attenuated mumps virus (RIT4385 strain), live attenuated rubella virus (Takahashi strain) 弱毒生麻しんウイルス(AIK-C株)、弱毒生ムンプスウイルス(RIT4385株)、弱毒生風しんウイルス(高橋株) | Daiichi Sankyo Company, Limited 第一三共(株) | Prevention of measles, mumps, and rubella 麻しん、おたふくかぜ及び風しんの予防 | New active ingredient standard | — | — | — | — | [1] [2] |
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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