PMDA · MHLW · monthly list
All drugs approved in Japan in August 2026, in English.
Last updated: 2026-10-02 · 23 approvals
Japan approved 23 drugs in August 2026 (approval date: 2026-08-24): 12 new indication, 5 new active ingredient, 2 new route, 2 new dosage form, 1 new combination, 1 biosimilar. Median lag vs FDA for this month: 0.9 years (328 days) (n=4).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2026-08-24 | ボトックスビスタ JP | Botulinum toxin type A A型ボツリヌス毒素 | AbbVie GK アッヴィ(同) | Masseteric hypertrophy in adults under 65 years of age 65歳未満の成人における咬筋膨隆 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | ブリヌスプリ JP | brensocatib hydrate ブレンソカチブ水和物 | Insmed GK インスメッド(同) | Non-cystic fibrosis bronchiectasis 非嚢胞性線維症性気管支拡張症 | New active ingredient standard | 2025-08-12 | 2025-11-18 | 377 d 1.0 y | 279 d 0.8 y | [1] [2] [3] [4] [5] |
| 2026-08-24 | ブフェニール JP | sodium phenylbutyrate フェニル酪酸ナトリウム Orphan | OrphanPacific, Inc. (株)オーファンパシフィック | Progressive familial intrahepatic cholestasis type 1 and type 2 進行性家族性肝内胆汁うっ滞症1型及び2型 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | ビレーズトリ JP | Budesonide /Glycopyrronium bromide/Formoterol fumarate hydrate ブデソニド/グリコピロニウム臭化物/ホルモテロールフマル酸塩水和物 | AstraZeneca K.K. アストラゼネカ(株) | Bronchial asthma (in cases where concurrent use of inhaled corticosteroids, long-acting inhaled anticholinergic agents, and long-acting inhaled beta-2 agonists is necessary) 気管支喘息(吸入ステロイド剤、長時間作用性吸入抗コリン剤及び長時間作用性吸入β2刺激剤の併用が必要な場合) | New combination standard | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | ヒブサーゴ JP | bepirovirsen sodium ベピロビルセンナトリウム SAKIGAKE | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Functional cure in persistent hepatitis B virus infection B型肝炎ウイルス持続感染における機能的治癒 | New active ingredient standardsakigake | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | ヒアニュオ JP | sevabertinib hydrate セバベルチニブ水和物 | Bayer Yakuhin, Ltd. バイエル薬品(株) | Unresectable advanced or recurrent non-small cell lung cancer with HER2 (ERBB2) gene mutation HER2(ERBB2)遺伝子変異陽性の切除不能な進行・再発の非小細胞肺癌 | New active ingredient orphanpriority | 2025-11-19 | — | 278 d 0.8 y | — | [1] [2] [3] [4] |
| 2026-08-24 | ゲムシタビン JP | Gemcitabine hydrochloride ゲムシタビン塩酸塩 | Nippon Kayaku Co., Ltd. 日本化薬(株) | Induction therapy with chemoradiotherapy for locally advanced nasopharyngeal cancer; Nasopharyngeal cancer with recurrence or distant metastasis 局所進行上咽頭癌における化学放射線療法の導入療法、再発又は遠隔転移を有する上咽頭癌 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | ゲムシタビン JP | Gemcitabine hydrochloride ゲムシタビン塩酸塩 | 高田製薬(株) JP | Induction therapy with chemoradiotherapy for locally advanced nasopharyngeal cancer; Nasopharyngeal cancer with recurrence or distant metastasis 局所進行上咽頭癌における化学放射線療法の導入療法、再発又は遠隔転移を有する上咽頭癌 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | オーゼイフル JP | oveporexton オベポレクストン | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Narcolepsy type 1 ナルコレプシータイプ1 | New active ingredient orphansakigakepriority | 2026-08-05 | — | 19 d 0.1 y | — | [1] [2] [3] [4] |
| 2026-08-24 | オヌレグ JP | Azacitidine アザシチジン Orphan | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Maintenance therapy for acute myeloid leukemia 急性骨髄性白血病における維持療法 | New route orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | イムシブリー JP | setmelanotide セトメラノチド酢酸塩 | リズムファーマ(株) JP | Acquired hypothalamic obesity 後天性視床下部性肥満 | New active ingredient orphanpriority | 2020-11-25 | 2021-07-16 | 2,098 d 5.7 y | 1,865 d 5.1 y | [1] [2] [3] [4] [5] |
| 2026-08-24 | イネレクスゾ JP | Gemcitabine hydrochloride ゲムシタビン塩酸塩 | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | High-risk non-muscle-invasive bladder cancer with carcinoma in situ persisting or recurring after intravesical BCG therapy BCG膀胱内注入療法後に残存・再発した上皮内癌を有する高リスク筋層非浸潤性膀胱癌 | New route orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | アベロックス JP | moxifloxacin hydrochloride モキシフロキサシン塩酸塩 | Bayer Yakuhin, Ltd. バイエル薬品(株) | Multidrug-resistant pulmonary tuberculosis caused by Mycobacterium tuberculosis 以下 〈適応菌種〉 結核菌 〈適応症〉 多剤耐性肺結核 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | 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) | Polyarticular juvenile idiopathic arthritis with active disease for which existing treatment is inadequate 既存治療で効果不十分な多関節に活動性を有する若年性特発性関節炎 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Pegfilgrastim BS ペグフィルグラスチムBS | pegfilgrastim (genetically recombinant) [pegfilgrastim biosimilar 2] ペグフィルグラスチム(遺伝子組換え)[ペグフィルグラスチム後続2] | Global Regulatory Partners GK グローバルレギュラトリーパートナーズ(同) | Prevention of febrile neutropenia caused by cancer chemotherapy がん化学療法による発熱性好中球減少症の発症抑制 | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Orladeyo オラデオ | Berotralstat hydrochloride ベロトラルスタット塩酸塩 | OrphanPacific, Inc. (株)オーファンパシフィック | Suppression of acute attacks of hereditary angioedema 遺伝性血管性浮腫の急性発作の発症抑制 | New dosage form orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Libtayo I.V. リブタヨ | Cemiplimab セミプリマブ(遺伝子組換え) Orphan | Regeneron Japan KK リジェネロン・ジャパン(株) | Adjuvant therapy following surgery for unresectable advanced or recurrent squamous cell carcinoma and high-risk recurrent squamous cell carcinoma 根治切除不能な進行・再発の有棘細胞癌及び再発高リスクの有棘細胞癌における術後補助療法 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Imfinzi イミフィンジ | Durvalumab デュルバルマブ(遺伝子組換え) | AstraZeneca K.K. アストラゼネカ(株) | High-risk non-muscle-invasive bladder cancer 高リスク筋層非浸潤性膀胱癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Hympavzi S.C. ヒムペブジ | Marstacimab マルスタシマブ(遺伝子組換え) | Pfizer Japan Inc. ファイザー(株) | (1) Prevention of bleeding episodes in patients with congenital hemophilia with inhibitors to clotting factors VIII or IX (2) Prevention of bleeding episodes in patients with congenital hemophilia without inhibitors to clotting factors VIII or IX (1) 血液凝固第VIII因子又は第IX因子に対するインヒビターを保有する先天性血友病患者における出血傾向の抑制 (2) 血液凝固第VIII因子又は第IX因子に対するインヒビターを保有しない先天性血友病患者における出血傾向の抑制 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Fludara I.V.Infusion フルダラ | Fludarabine phosphate フルダラビンリン酸エステル | Sanofi K.K. サノフィ(株) | Conditioning prior to allogeneic hematopoietic stem cell transplantation 同種造血幹細胞移植の前治療 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Empaveli エムパベリ | Pegcetacoplan ペグセタコプラン Orphan | Swedish Orphan Biovitrum Japan Co., Ltd. Swedish Orphan Biovitrum Japan(株) | C3 glomerulonephritis; Primary immune complex-mediated membranoproliferative glomerulonephritis C3腎症、一次性免疫複合体型膜性増殖性糸球体腎炎 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | Besremi ベスレミ | Ropeginterferon alfa-2b ロペグインターフェロン アルファ-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) | Essential thrombocythemia 本態性血小板血症 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-08-24 | 1) Stelara ステラーラ | Ustekinumab ウステキヌマブ(遺伝子組換え) Orphan | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | (1) Induction therapy for moderate to severe active Crohn's disease (limited to cases where existing treatments are inadequate) (2) (3) Maintenance therapy for moderate to severe active Crohn's disease (limited to cases where existing treatments are inadequate) (1) 中等症から重症の活動期クローン病の導入療法(既存治療で効果不十分な場合に限る) (2) (3) 中等症から重症の活動期クローン病の維持療法(既存治療で効果不十分な場合に限る) | New dosage form orphanpriority | — | — | — | — | [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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