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All drugs approved in Japan in February 2026, in English.
Last updated: 2026-10-02 · 15 approvals
Japan approved 15 drugs in February 2026 (approval date: 2026-02-19): 5 new indication, 3 new dosage, 3 new active ingredient, 2 new route, 1 other, 1 new combination. Median lag vs FDA for this month: 4.4 years (1,605 days) (n=3).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 | Vonvendi ボンベンディ | Vonicog alfa ボニコグ アルファ(遺伝子組換え) | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Control of bleeding tendency in patients with von Willebrand disease (VWD) von Willebrand病患者における出血傾向の抑制 | New dosage orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Tukysa ツカイザ | Tucatinib ethanolate ツカチニブ エタノール付加物 | Pfizer Japan Inc. ファイザー(株) | Treatment of human epidermal growth factor receptor 2 (HER2)-positive inoperable or recurrent breast cancer in patients who have previously been treated with chemotherapy 化学療法歴のあるHER2陽性の手術不能又は再発乳癌 | New active ingredient standard | 2020-04-17 | 2021-02-11 | 2,134 d 5.8 y | 1,834 d 5.0 y | [1] [2] [3] [4] [5] |
| 2026-02-19 | 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) | Remission induction therapy for 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寛解導入及び維持療法(既存治療で効果不十分な場合に限る) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Tezspire テゼスパイア | Tezepelumab テゼペルマブ(遺伝子組換え) | AstraZeneca K.K. アストラゼネカ(株) | Treatment of chronic rhinosinusitis with nasal polyps (for use only in patients who have not responded sufficiently to conventional treatments) 鼻茸を伴う慢性副鼻腔炎(既存治療で効果不十分な患者に限る) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Sohonos ソホノス | Palovarotene パロバロテン Orphan | IPSEN Co., Ltd. IPSEN(株) | Treatment of fibrodysplasia ossificans progressiva 進行性骨化性線維異形成症 | New active ingredient orphanpriority | 2023-08-16 | — | 918 d 2.5 y | — | [1] [2] [3] [4] |
| 2026-02-19 | Saphnelo サフネロー | Anifrolumab アニフロルマブ(遺伝子組換え) | AstraZeneca K.K. アストラゼネカ(株) | Treatment of systemic lupus erythematosus in patients who have not responded sufficiently to conventional treatments 既存治療で効果不十分な全身性エリテマトーデス | New route standard | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Rituxan リツキサン | Rituximab リツキシマブ(遺伝子組換え) | Zenyaku Kogyo Co., Ltd. 全薬工業(株) | Treatment of autoimmune hemolytic anemia 自己免疫性溶血性貧血 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Parmodia XR パルモディアXR | Pemafibrate ペマフィブラート | Kowa Company, Ltd. 興和(株) | Treatment of hyperlipidemia (including familial hyperlipidemia) 高脂血症(家族性を含む) | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Mekinist メキニスト | Trametinib dimethyl sulfoxide トラメチニブ ジメチルスルホキシド付和物 | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of low-grade serous ovarian cancer that has progressed after cancer chemotherapy がん化学療法後に増悪した低異型度漿液性卵巣癌 | Other standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Kyinsu キーンス | Insulin Icodec/ Semaglutide インスリン イコデク(遺伝子組換え)/セマグルチド(遺伝子組換え) | Novo Nordisk Pharma Ltd. ノボ ノルディスク ファーマ(株) | Treatment of type 2 diabetes mellitus in cases where insulin therapy is indicated インスリン療法が適応となる2型糖尿病 | New combination standard | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Keytruda キイトルーダ | Pembrolizumab ペムブロリズマブ(遺伝子組換え) | MSD K.K. MSD(株) | Preoperative and postoperative adjuvant treatment for locally advanced head and neck cancer 局所進行頭頸部癌における術前・術後補助療法 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Ilaris イラリス | Canakinumab カナキヌマブ(遺伝子組換え) Orphan | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of Schnitzler syndrome シュニッツラー症候群 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Diagnogreen ジアグノグリーン | Indocyanine green インドシアニングリーン | Daiichi Sankyo Company, Limited 第一三共(株) | Sentinel lymph node mapping in cervical and endometrial cancer and evaluation of lymphatic flow related to lymphaticovenular anastomosis ○次の疾患におけるセンチネルリンパ節の同定 子宮頸癌、子宮体癌 ○リンパ管静脈吻合術に係るリンパ流の評価 | New route standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Besremi ベスレミ | Ropeginterferon alfa-2a ロペグインターフェロン アルファー2b(遺伝子組換え) | PharmaEssence Japan K.K. ファーマエッセンシアジャパン(株) | Treatment of polycythaemia vera (use only when conventional therapies are not sufficiently effective or inappropriate) 真性多血症(既存治療が効果不十分又は不適当な場合に限る) | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2026-02-19 | Aquipta アクイプタ | Atogepant hydrate アトゲパント水和物 | AbbVie GK アッヴィ(同) | Prevention of migraine attacks 片頭痛発作の発症抑制 | New active ingredient standard | 2021-09-28 | 2023-08-11 | 1,605 d 4.4 y | 923 d 2.5 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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