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All drugs approved in Japan in March 2026, in English.
Last updated: 2026-10-02 · 21 approvals
Japan approved 21 drugs in March 2026 (approval dates: 2026-03-06, 2026-03-23): 11 new indication, 5 new active ingredient, 3 biosimilar, 2 new dosage. Median lag vs FDA for this month: 1.4 years (525 days) (n=4).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2026-03-23 | ルセフィ JP | luseogliflozin hydrate ルセオグリフロジン水和物 | Taisho Pharmaceutical Co., Ltd. 大正製薬(株) | Type 2 diabetes mellitus 2型糖尿病 | New dosage standard | — | — | — | — | [1] [2] |
| 2026-03-23 | ハイツエキシン JP | lisovarisib mesylate hydrate リソバリシブメシル酸塩水和物 Orphan | Haihe Biopharma K. K. 海和製薬(株) | Clear cell carcinoma of the ovary with PIK3CA gene mutation that has progressed after cancer chemotherapy がん化学療法後に増悪したPIK3CA遺伝子変異を有する卵巣明細胞癌 | New active ingredient orphanpriority | — | — | — | — | [1] [2] |
| 2026-03-23 | ドジョルビ JP | triheptanoin トリヘプタノイン Conditional | Ultragenyx Japan K.K. Ultragenyx Japan(株) | Long-chain fatty acid oxidation disorders 長鎖脂肪酸代謝異常症 | New active ingredient orphanconditionalpriority | 2020-06-30 | — | 2,092 d 5.7 y | — | [1] [2] [3] |
| 2026-03-23 | ジョエンジャ JP | leniolisib phosphate レニオリシブリン酸塩 | OrphanPacific, Inc. (株)オーファンパシフィック | Activated PI3K delta syndrome 活性化PI3Kδ症候群 | New active ingredient orphanpriority | 2023-03-24 | 2026-05-21 | 1,095 d 3.0 y | 59 d earlier Japan first | [1] [2] [3] [4] |
| 2026-03-23 | オマリズマブBS JP | omalizumab [omalizumab biosimilar 1] オマリズマブ(遺伝子組換え)[オマリズマブ後続1] | Celltrion Healthcare Japan K.K. セルトリオン・ヘルスケア・ジャパン(株) | ① Asthma (limited to patients with refractory disease whose asthma symptoms cannot be controlled with existing treatment) ② Seasonal allergic rhinitis (limited to patients with severe or most severe disease where existing treatment is inadequately effective) ③ Idiopathic chronic urticaria (limited to patients where existing treatment is inadequately effective) ○気管支喘息(既存治療によっても喘息症状をコントロールできない難治の患者に限る) ○季節性アレルギー性鼻炎(既存治療で効果不十分な重症又は最重症患者に限る) ○特発性の慢性蕁麻疹(既存治療で効果不十分な患者に限る) | Biosimilar standard | — | — | — | — | [1] [2] |
| 2026-03-23 | イフェクサーSR JP | venlafaxine hydrochloride ベンラファキシン塩酸塩 | ヴィアトリス製薬(同) JP | Generalized anxiety disorder 全般不安症 | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | アムベルビスト JP | gadoquatrane ガドクアトラン水和物 | Bayer Yakuhin, Ltd. バイエル薬品(株) | Contrast-enhanced magnetic resonance imaging: brain and spinal cord; trunk and extremities 磁気共鳴コンピューター断層撮影における下記造影 脳・脊髄造影 躯幹部・四肢造影 | New active ingredient standard | 2026-06-12 | — | 81 d earlier Japan first | — | [1] [2] [3] |
| 2026-03-23 | Xocova ゾコーバ | Ensitrelvir fumaric acid エンシトレルビル フマル酸 | Shionogi & Co., Ltd. 塩野義製薬(株) | Prevention of infection caused by SARS-CoV-2 SARS-CoV-2による感染症の予防 | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Trodelvy トロデルビ | Sacituzumab govitecan サシツズマブ ゴビテカン(遺伝子組換え) | Gilead Sciences, Inc. ギリアド・サイエンシズ(株) | Hormone receptor-positive and HER2-negative unresectable or recurrent breast cancer with prior chemotherapy 化学療法歴のあるホルモン受容体陽性かつHER2陰性の手術不能又は再発乳癌 | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Tocilizumab BS トシリズマブBS | tocilizumab [tocilizumab biosimilar 2] トシリズマブ(遺伝子組換え)[トシリズマブ後続2] | Mochida Pharmaceutical Co., Ltd. 持田製薬(株) | (1) (2) (3) Treatment of the following diseases for which existing treatments are inadequate: rheumatoid arthritis (including prevention of structural joint damage), polyarticular juvenile idiopathic arthritis with active involvement, systemic juvenile idiopathic arthritis; improvement of symptoms and laboratory findings associated with Castleman disease (elevated C-reactive protein, elevated fibrinogen, increased erythrocyte sedimentation rate, decreased hemoglobin, decreased albumin, general malaise), limited to patients for whom lymph node excision is not indicated; treatment of cytokine release syndrome associated with malignant tumor therapy; treatment of pneumonia caused by SARS-CoV-2, limited to patients requiring oxygen supplementation (4) (5) Treatment of the following diseases for which existing treatments are inadequate: rheumatoid arthritis (including prevention of structural joint damage) (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 〇SARS-CoV-2による肺炎(ただし、酸素投与を要する患者に限る) (4) (5) 既存治療で効果不十分な下記疾患 〇関節リウマチ(関節の構造的損傷の防止を含む) | Biosimilar standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Talzenna ターゼナ | Talazoparib tosilate タラゾパリブトシル酸塩 | Pfizer Japan Inc. ファイザー(株) | Castration-resistant prostate cancer with distant metastasis 遠隔転移を有する去勢抵抗性前立腺癌 | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Polivy ポライビー | Polatuzumab vedotin ポラツズマブ ベドチン(遺伝子組換え) | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Large B-cell lymphomas: diffuse large B-cell lymphoma; high-grade B-cell lymphoma; recurrent or refractory follicular lymphoma 以下の大細胞型B細胞リンパ腫 びまん性大細胞型B細胞リンパ腫 高悪性度B細胞リンパ腫 再発又は難治性の濾胞性リンパ腫 | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Paxlovidpack パキロビッドパック | nirmatrelvir, ritonavir ニルマトレルビル、リトナビル | Pfizer Japan Inc. ファイザー(株) | Infection caused by SARS-CoV-2 SARS-CoV-2による感染症 | New dosage standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Nubeqa ニュベクオ | Darolutamide ダロルタミド Orphan | Bayer Yakuhin, Ltd. バイエル薬品(株) | Androgen receptor-positive unresectable advanced or recurrent salivary gland cancer アンドロゲン受容体陽性の根治切除不能な進行・再発の唾液腺癌 | New indication orphanpriority | — | — | — | — | [1] [2] |
| 2026-03-23 | Lunsumio ルンスミオ | Mosunetuzumab モスネツズマブ(遺伝子組換え) | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Recurrent or refractory large B-cell lymphomas: diffuse large B-cell lymphoma; high-grade B-cell lymphoma; recurrent or refractory follicular lymphoma 以下の再発又は難治性の大細胞型B細胞リンパ腫 びまん性大細胞型B細胞リンパ腫 高悪性度B細胞リンパ腫 再発又は難治性の濾胞性リンパ腫 | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Fibrinogen HT I.V. フィブリノゲンHT | Freeze-dried human fibrinogen 乾燥人フィブリノゲン | Japan Blood Products Organization (一社)日本血液製剤機構 | Supplementation of fibrinogen for acquired hypofibrinogenemia associated with bleeding in cardiovascular surgery 心臓血管外科手術における出血に伴う後天性低フィブリノゲン血症に対するフィブリノゲンの補充 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] |
| 2026-03-23 | Eylea アイリーア | Aflibercept アフリベルセプト(遺伝子組換え) | Bayer Yakuhin, Ltd. バイエル薬品(株) | Macular edema associated with retinal vein occlusion 網膜静脈閉塞症に伴う黄斑浮腫 | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | 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) | HER2-positive advanced or recurrent solid tumors (only when standard treatment is difficult) HER2陽性の進行・再発の固形癌(標準的な治療が困難な場合に限る) | New indication standard | — | — | — | — | [1] [2] |
| 2026-03-23 | Dupixent デュピクセント | Dupilumab デュピルマブ(遺伝子組換え) Orphan | Sanofi K.K. サノフィ(株) | Moderate to severe bullous pemphigoid 中等症から重症の水疱性類天疱瘡 | New indication orphanpriority | — | — | — | — | [1] [2] |
| 2026-03-23 | Aflibercept BS アフリベルセプトBS硝子体内 | aflibercept [aflibercept biosimilar 4] アフリベルセプト(遺伝子組換え)[アフリベルセプト後続4] | Celltrion Healthcare Japan K.K. セルトリオン・ヘルスケア・ジャパン(株) | Age-related macular degeneration with subfoveal choroidal neovascularization; macular edema associated with retinal vein occlusion; choroidal neovascularization in pathologic myopia; diabetic macular edema 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 糖尿病黄斑浮腫 | Biosimilar standard | — | — | — | — | [1] [2] |
| 2026-03-06 | イドビンソ JP | doravirine/islatravir hydrate ドラビリン/イスラトラビル水和物 | MSD K.K. MSD(株) | HIV-1 infection HIV-1感染症 | New active ingredient orphanpriority | 2026-04-20 | — | 45 d earlier Japan first | — | [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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