PMDA · MHLW · monthly list
All drugs approved in Japan in September 2026, in English.
Last updated: 2026-10-02 · 32 approvals
Japan approved 32 drugs in September 2026 (approval date: 2026-09-16): 12 new active ingredient, 11 new indication, 3 new dosage, 3 new dosage form, 1 new combination, 1 biosimilar, 1 new route. Median lag vs FDA for this month: 5.2 years (1,900 days) (n=8).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2026-09-16 | 注射用メソトレキセート JP | Methotrexate メトトレキサート | Pfizer Japan Inc. ファイザー(株) | Suppression of graft-versus-host disease in hematopoietic stem cell transplantation 造血幹細胞移植時の移植片対宿主病の抑制 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | モビコール JP | macrogol 4000, sodium chloride, sodium bicarbonate, potassium chloride マクロゴール4000・塩化ナトリウム・炭酸水素ナトリウム・塩化カリウム | EA Pharma Co., Ltd. EAファーマ(株) | Chronic constipation (excluding constipation due to organic diseases) 慢性便秘症(器質的疾患による便秘を除く) | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | モデーソ JP | dordaviprone hydrochloride ドルダビプロン塩酸塩 Orphan | Ohara Pharmaceutical Co.,Ltd. 大原薬品工業(株) | Diffuse midline glioma びまん性正中膠腫 | New active ingredient orphanpriority | 2025-08-06 | — | 406 d 1.1 y | — | [1] [2] [3] [4] |
| 2026-09-16 | ビエプチ JP | eptinezumab エプチネズマブ(遺伝子組換え) | ルンドベック・ジャパン(株) JP | Prevention of migraine attacks 片頭痛発作の発症抑制 | New active ingredient standard | 2020-02-21 | 2022-01-24 | 2,399 d 6.6 y | 1,696 d 4.6 y | [1] [2] [3] [4] [5] |
| 2026-09-16 | シービーパック持続的血 JP | 医療用配合剤のため該当しない JP | Nipro Corporation ニプロ(株) | Replacement fluid and dialysate for continuous blood purification therapy 持続的血液浄化療法施行時の補充液及び透析液として用いる | New combination standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | サブパック血 JP | 医療用配合剤のため該当しない JP | Nipro Corporation ニプロ(株) | Replacement fluid and dialysate for continuous blood purification therapy 持続的血液浄化療法施行時の補充液及び透析液として用いる | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | クライジェファ JP | gefurulimab (genetically recombinant) ゲフルリマブ(遺伝子組換え) | Alexion Pharma GK アレクシオンファーマ(同) | Generalized myasthenia gravis (only when corticosteroids or other immunosuppressive agents are inadequately effective) 全身型重症筋無力症(ステロイド剤又はステロイド剤以外の免疫抑制剤が十分に奏効しない場合に限る) | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | キイジェクト JP | pembrolizumab (genetically recombinant), verahydaluronidase alfa (genetically recombinant) ペムブロリズマブ(遺伝子組換え)、ベラヒアルロニダーゼ アルファ(遺伝子組換え) | MSD K.K. MSD(株) | Malignant melanoma; unresectable advanced or recurrent non-small cell lung cancer; adjuvant therapy for non-small cell lung cancer; recurrent or refractory classical Hodgkin lymphoma; unresectable urothelial cancer; advanced or recurrent solid tumors with high microsatellite instability (MSI-High) that have progressed after cancer chemotherapy (only when standard treatment is difficult); unresectable or metastatic renal cell carcinoma; adjuvant therapy for renal cell carcinoma; head and neck cancer with recurrence or distant metastasis; adjuvant therapy for locally advanced head and neck cancer; unresectable advanced or recurrent esophageal cancer; incurable advanced or recurrent colorectal cancer with high microsatellite instability (MSI-High); PD-L1-positive hormone receptor-negative and HER2-negative unresectable or recurrent breast cancer; neoadjuvant and adjuvant therapy for hormone receptor-negative and HER2-negative breast cancer at high risk of recurrence; advanced or recurrent endometrial cancer; advanced or recurrent solid tumors with high tumor mutational burden (TMB-High) that have progressed after cancer chemotherapy (only when standard treatment is difficult); advanced or recurrent cervical cancer; locally advanced cervical cancer; recurrent or refractory primary mediastinal large B-cell lymphoma; incurable advanced or recurrent gastric cancer; incurable cholangiocarcinoma; unresectable advanced or recurrent malignant pleural mesothelioma; platinum-resistant recurrent ovarian cancer 悪性黒色腫 切除不能な進行・再発の非小細胞肺癌 非小細胞肺癌における術前・術後補助療法 再発又は難治性の古典的ホジキンリンパ腫 根治切除不能な尿路上皮癌 がん化学療法後に増悪した進行・再発の高頻度マイクロサテライト不安定性(MSI-High)を有する固形癌(標準的な治療が困難な場合に限る) 根治切除不能又は転移性の腎細胞癌 腎細胞癌における術後補助療法 再発又は遠隔転移を有する頭頸部癌 局所進行頭頸部癌における術前・術後補助療法 根治切除不能な進行・再発の食道癌 治癒切除不能な進行・再発の高頻度マイクロサテライト不安定性(MSI-High)を有する結腸・直腸癌 PD-L1陽性のホルモン受容体陰性かつHER2陰性の手術不能又は再発乳癌 ホルモン受容体陰性かつHER2陰性で再発高リスクの乳癌における術前・術後薬物療法 進行・再発の子宮体癌 がん化学療法後に増悪した高い腫瘍遺伝子変異量(TMB-High)を有する進行・再発の固形癌(標準的な治療が困難な場合に限る) 進行又は再発の子宮頸癌 局所進行子宮頸癌 再発又は難治性の原発性縦隔大細胞型B細胞リンパ腫 治癒切除不能な進行・再発の胃癌 治癒切除不能な胆道癌 切除不能な進行・再発の悪性胸膜中皮腫 白金系抗悪性腫瘍剤抵抗性の再発卵巣癌 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | ガミファント JP | emapalumab (genetically recombinant) エマパルマブ(遺伝子組換え) Orphan | Swedish Orphan Biovitrum Japan Co., Ltd. Swedish Orphan Biovitrum Japan(株) | Macrophage activation syndrome associated with systemic-onset juvenile idiopathic arthritis or adult-onset Still's disease 全身型若年性特発性関節炎又は成人発症スチル病に伴うマクロファージ活性化症候群 | New active ingredient orphanpriority | 2018-11-20 | — | 2,857 d 7.8 y | — | [1] [2] [3] [4] |
| 2026-09-16 | オンスイク JP | insulin efsitora alfa (genetically recombinant) インスリン エフシトラ アルファ(遺伝子組換え) | Eli Lilly Japan K.K. 日本イーライリリー(株) | Type 2 diabetes mellitus for which insulin therapy is indicated インスリン療法が適応となる2型糖尿病 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | オジェンダドライ JP | tovorafenib トボラフェニブ Conditional | Ipsen Co., Ltd. IPSEN(株) | Low-grade glioma with BRAF gene mutation or fusion gene BRAF遺伝子変異又は融合遺伝子を有する低悪性度神経膠腫 | New active ingredient orphanconditionalpriority | 2024-04-23 | 2026-04-20 | 876 d 2.4 y | 149 d 0.4 y | [1] [2] [3] [4] [5] |
| 2026-09-16 | エラヒア JP | mirvetuximab soravtansine ミルベツキシマブ ソラブタンシン(遺伝子組換え) | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Folate receptor alpha-positive platinum-resistant recurrent ovarian cancer 葉酸受容体α陽性の白金系抗悪性腫瘍剤抵抗性の再発卵巣癌 | New active ingredient orphanpriority | 2022-11-14 | 2024-11-14 | 1,402 d 3.8 y | 671 d 1.8 y | [1] [2] [3] [4] [5] |
| 2026-09-16 | エキスコプリ JP | cenobamate セノバメート | Ono Pharmaceutical Co., Ltd. 小野薬品工業(株) | Partial seizures in epilepsy patients (including secondarily generalized seizures) てんかん患者の部分発作(二次性全般化発作を含む) | New active ingredient standard | 2019-11-21 | 2021-03-26 | 2,491 d 6.8 y | 2,000 d 5.5 y | [1] [2] [3] [4] [5] |
| 2026-09-16 | ウエキクス JP | pitolisant hydrochloride ピトリサント塩酸塩 | ヴィアトリス製薬(同) JP | (1) Excessive daytime sleepiness associated with obstructive sleep apnea syndrome in patients undergoing treatment for airway obstruction (such as continuous positive airway pressure (CPAP) therapy) (2) Narcolepsy (1) 持続陽圧呼吸(CPAP)療法等による気道閉塞に対する治療を実施中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気 (2) ナルコレプシー | New active ingredient orphanpriority | 2019-08-14 | 2016-03-31 | 2,590 d 7.1 y | 3,821 d 10.5 y | [1] [2] [3] [4] [5] |
| 2026-09-16 | イコタイド JP | icotrokinra hydrochloride イコトロキンラ塩酸塩 | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Plaque psoriasis, pustular psoriasis, and erythrodermic psoriasis where existing treatment is inadequately effective 既存治療で効果不十分な尋常性乾癬、膿疱性乾癬、乾癬性紅皮症 | New active ingredient standard | 2026-03-17 | 2026-09-18 | 183 d 0.5 y | 2 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2026-09-16 | アミロペイブ JP | anselamimab (genetically recombinant) アンセラミマブ(遺伝子組換え) Orphan | Alexion Pharma GK アレクシオンファーマ(合) | AL amyloidosis (only when immunoglobulin light chain is predominantly kappa type) 全身性ALアミロイドーシス(免疫グロブリン軽鎖がκ型優位の場合に限る) | New active ingredient orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Vtama ブイタマー | Tapinarof タピナロフ | Shionogi & Co., Ltd. 塩野義製薬(株) | Atopic dermatitis アトピー性皮膚炎 | New dosage form standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Ustekinumab BS ウステキヌマブBS | ustekinumab [ustekinumab biosimilar 5] ウステキヌマブ(遺伝子組換え)[ウステキヌマブ後続5] | (株)Meiji Seika ファルマ JP | (1) Treatment of the following diseases for which existing treatments are inadequate: plaque psoriasis, psoriatic arthritis; maintenance therapy for moderate to severe active Crohn's disease (limited to cases where existing treatments are inadequate); maintenance therapy for moderate to severe active ulcerative colitis (limited to cases where existing treatments are inadequate) (2) Induction therapy for moderate to severe active Crohn's disease (limited to cases where existing treatments are inadequate); remission induction therapy for moderate to severe active ulcerative colitis (limited to cases where existing treatments are inadequate) (1) ・既存治療で効果不十分な下記疾患 尋常性乾癬、乾癬性関節炎 ・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) ・中等症から重症の潰瘍性大腸炎の維持療法(既存治療で効果不十分な場合に限る) (2) ・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) ・中等症から重症の潰瘍性大腸炎の寛解導入療法(既存治療で効果不十分な場合に限る) | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Uplizna ユプリズナ | Inebilizumab イネビリズマブ(遺伝子組換え) Orphan | 田辺ファーマ(株) JP | Generalized myasthenia gravis (only when corticosteroids or other immunosuppressive agents are inadequately effective) 全身型重症筋無力症(ステロイド剤又はステロイド剤以外の免疫抑制剤が十分に奏効しない場合に限る) | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Tevimbra I.V. テビムブラ | Tislelizumab チスレリズマブ(遺伝子組換え) OrphanConditional | ビーワン・メディシンズ(同) JP | Nasopharyngeal cancer with recurrence or distant metastasis 再発又は遠隔転移を有する上咽頭癌 | New indication orphanconditionalpriority | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Tecvayli テクベイリ | Teclistamab テクリスタマブ(遺伝子組換え) | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Recurrent or refractory multiple myeloma 再発又は難治性の多発性骨髄腫腫 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Skyrizi スキリージ | Risankizumab リサンキズマブ(遺伝子組換え) Orphan | AbbVie GK アッヴィ(同) | Plaque psoriasis, pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis where existing treatment is inadequately effective 既存治療で効果不十分な尋常性乾癬、膿疱性乾癬、乾癬性紅皮症、乾癬性関節炎 | New dosage form orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Rybrofaz リブロファズ | amivantamab, vorbihyaluronidase alpha アミバンタマブ(遺伝子組換え)、ボルヒアルロニダーゼ アルファ(遺伝子組換え) | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Unresectable advanced or recurrent non-small cell lung cancer with EGFR gene exon 20 insertion mutation; unresectable advanced or recurrent non-small cell lung cancer with EGFR gene mutation EGFR遺伝子エクソン20挿入変異陽性の切除不能な進行・再発の非小細胞肺癌 EGFR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 dosage form standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Leqembi レケンビ | Lecanemab レカネマブ(遺伝子組換え) | Eisai Co., Ltd. エーザイ(株) | Slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease アルツハイマー病による軽度認知障害及び軽度の認知症の進行抑制 | New route standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | 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) | Platinum-resistant recurrent ovarian cancer 白金系抗悪性腫瘍剤抵抗性の再発卵巣癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Ibrance イブランス | Palbociclib パルボシクリブ | Pfizer Japan Inc. ファイザー(株) | Maintenance therapy after chemotherapy for hormone receptor-positive and HER2-positive unresectable or recurrent breast cancer ホルモン受容体陽性かつHER2陽性の手術不能又は再発乳癌における化学療法後の維持療法 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Fabhalta ファビハルタ | Iptacopan hydrochloride hydrate イプタコパン塩酸塩水和物 Orphan | Novartis Pharma K.K. ノバルティスファーマ(株) | IgA nephropathy IgA腎症 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Epkinly エプキンリ | Epcoritamab エプコリタマブ(遺伝子組換え) | Genmab K.K. ジェンマブ(株) | Recurrent or refractory follicular lymphoma 再発又は難治性の濾胞性リンパ腫 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | 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 unresectable or recurrent breast cancer HER2 陽性の手術不能又は再発乳癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Datroway ダトロウェイ | Datopotamab deruxtecan ダトポタマブ デルクステカン(遺伝子組換え) | Daiichi Sankyo Company, Limited 第一三共(株) | Hormone receptor-negative and HER2-negative unresectable or recurrent breast cancer ホルモン受容体陰性かつHER2陰性の手術不能又は再発乳癌 | New indication priority | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Covgoze コブゴーズ | Recombinant coronavirus (SARS-CoV-2) vaccine 組換えコロナウイルス(SARS-CoV-2)ワクチン | 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 dosage standard | — | — | — | — | [1] [2] [3] |
| 2026-09-16 | Capvaxive キャップバックス | Pneumococcal polysaccharide conjugated to CRM197 carrier protein 肺炎球菌莢膜ポリサッカライド-CRM197結合体 | MSD K.K. MSD(株) | Prevention of pneumococcal infections in elderly persons or those 2 years of age or older at high risk of pneumococcal disease 高齢者又は2歳以上の肺炎球菌による疾患に罹患するリスクが高いと考えられる者における肺炎球菌による感染症の予防 | New indication standard | — | — | — | — | [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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