PMDA · MHLW · monthly list
All drugs approved in Japan in September 2024, in English.
Last updated: 2026-10-02 · 34 approvals
Japan approved 34 drugs in September 2024 (approval dates: 2024-09-05, 2024-09-13, 2024-09-24): 15 new indication, 14 new active ingredient, 2 new dosage, 2 other, 1 new combination. Median lag vs FDA for this month: 3.6 years (1,300 days) (n=12).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-09-24 | Yuvanci ユバンシ | Macitentan/Tadalafil マシテンタン/タダラフィル | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of pulmonary arterial hypertension 肺動脈性肺高血圧症 | New combination standard | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Venoglobulin IH 献血ヴェノグロブリンIH | Polyethylene glycol treated human normal immunoglobulin ポリエチレングリコール処理人免疫グロブリン Orphan | Japan Blood Products Organization (一社)日本血液製剤機構 | Treatment of antibody-mediated rejection in the following organ transplantations; kidney transplantation, liver transplantation, heart transplantation, lung transplantation, pancreas transplantation, small intestine transplantation 下記の臓器移植における抗体関連型拒絶反応の治療 腎移植、肝移植、心移植、肺移植、膵移植、小腸移植 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Veltassa ビルタサ | Patiromer sorbitex calcium パチロマーソルビテクスカルシウム | Zeria Pharmaceutical Co., Ltd. ゼリア新薬工業(株) | Treatment of hyperkalaemia 高カリウム血症 | New active ingredient standard | 2015-10-21 | 2017-07-19 | 3,261 d 8.9 y | 2,624 d 7.2 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | 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) | Treatment of hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative unresectable or recurrent breast cancer in patients who have previously been treated with chemotherapy 化学療法歴のある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 active ingredient priority | 2020-04-22 | 2021-11-22 | 1,616 d 4.4 y | 1,037 d 2.8 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | Treprost トレプロスト | Treprostinil トレプロスチニル Orphan | Mochida Pharmaceutical Co., Ltd. 持田製薬(株) | Treatment of pulmonary hypertension associated with interstitial lung disease 間質性肺疾患に伴う肺高血圧症 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Tepezza テッペーザ | Teprotumumab テプロツムマブ(遺伝子組換え) Orphan | Amgen K.K. アムジェン(株) | Treatment of active thyroid eye disease 活動性甲状腺眼症 | New active ingredient orphanpriority | 2020-01-21 | 2025-06-19 | 1,708 d 4.7 y | 268 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2024-09-24 | Tasfygo タスフィゴ | Tasurgratinib succinate タスルグラチニブコハク酸塩 | Eisai Co., Ltd. エーザイ(株) | Treatment of unresectable FGFR2 fusion gene-positive biliary tract cancer that has progressed after cancer chemotherapy がん化学療法後に増悪したFGFR2融合遺伝子陽性の治癒切除不能な胆道癌 | New active ingredient orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Tafinlar タフィンラー小児用分 | Dabrafenib mesilate ダブラフェニブメシル酸塩 Orphan | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of BRAF mutation-positive low-grade glioma. (2) (3) Drugs with a new indication for the treatment of BRAF mutation-positive low-grade glioma (1) BRAF遺伝子変異を有する低悪性度神経膠腫 (2) (3) BRAF遺伝子変異を有する低悪性度神経膠腫 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Septocaine セプトカイン | Articaine hydrochloride/ Adrenaline bitartrate アルチカイン塩酸塩/アドレナリン酒石酸水素塩 | GC Showayakuhin Corporation (株)ジーシー昭和薬品 | Infiltration anesthesia or nerve block in the fields of dentistry and oral surgery 歯科領域及び口腔外科領域における浸潤麻酔又は伝達麻酔 | New active ingredient standard | 2000-04-03 | — | 8,940 d 24.5 y | — | [1] [2] [3] [4] |
| 2024-09-24 | Rybrevant ライブリバント | Amivantamab アミバンタマブ(遺伝子組換え) | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) gene exon 20 insertion mutation-positive non-small cell lung cancer 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 | New active ingredient standard | 2021-05-21 | 2021-12-09 | 1,222 d 3.3 y | 1,020 d 2.8 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | Rozebalamin ロゼバラミン | Mecobalamin メコバラミン Orphan | Eisai Co., Ltd. エーザイ(株) | Slowing the progression of functional impairment in patients with amyotrophic lateral sclerosis (ALS) 筋萎縮性側索硬化症(ALS)における機能障害の進行抑制 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Rituxan リツキサン | Rituximab リツキシマブ(遺伝子組換え) Orphan | Zenyaku Kogyo Co., Ltd. 全薬工業(株) | Treatment of refractory nephrotic syndrome (for use steroid-resistant nephrotic syndrome) 難治性のネフローゼ症候群(ステロイド抵抗性を示す場合) | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | 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) | Treatment of atopic dermatitis in patients who have not responded sufficiently to conventional treatments 既存治療で効果不十分なアトピー性皮膚炎 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Rexulti レキサルティ | Brexpiprazole ブレクスピプラゾール | Otsuka Pharmaceutical Co., Ltd. 大塚製薬(株) | Treatment of excessive motor activity or verbal/physical aggression attributable to rapid changes in mood and/or irritability, outburst associated with Alzheimer's dementia アルツハイマー型認知症に伴う焦燥感、易刺激性、興奮に起因する、過活動又は攻撃的言動 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Quviviq クービビック | Daridorexant hydrochloride ダリドレキサント塩酸塩 | Nexera Pharma Co., Ltd. ネクセラファーマジャパン(株) | Treatment of insomnia 不眠症 | New active ingredient standard | 2022-01-07 | 2022-04-29 | 991 d 2.7 y | 879 d 2.4 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | Padcev パドセブ | Enfortumab vedotin エンホルツマブ ベドチン(遺伝子組換え) | Astellas Pharma Inc. アステラス製薬(株) | Treatment of unresectable urothelial carcinoma 根治切除不能な尿路上皮癌 | New indication priority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | NovoSeven HI ノボセブンHI | Eptacog alfa (activated) エプタコグ アルファ(活性型)(遺伝子組換え) | Novo Nordisk Pharma Ltd. ノボ ノルディスク ファーマ(株) | Control of bleeding tendency in patients with Glantzmann thrombasthenia グランツマン血小板無力症患者の出血傾向の抑制 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Mekinist メキニスト小児用ドライ | Trametinib dimethyl sulfoxide トラメチニブ ジメチルスルホキシド付加物 Orphan | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of BRAF mutation-positive low-grade glioma. (2) (3) Drugs with a new indication for the treatment of BRAF mutation-positive low-grade glioma (1) BRAF遺伝子変異を有する低悪性度神経膠腫 (2) (3) BRAF遺伝子変異を有する低悪性度神経膠腫 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Mearubik II ミールビックII | Live attenuated measles virus (Tanabe strain) and live attenuated rubella virus (Matsuura/J16 strain) 弱毒生麻しんウイルス田辺株及び弱毒生風しんウイルス松浦/J16株 | The Research Foundation for Microbial Diseases of Osaka University (一財)阪大微生物病研究会 | Prevention of measles and rubella 麻しん及び風しんの予防 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Lupkynis ルプキネス | Voclosporin ボクロスポリン | Otsuka Pharmaceutical Co., Ltd. 大塚製薬(株) | Treatment of lupus nephritis ループス腎炎 | New active ingredient standard | 2021-01-22 | 2022-09-15 | 1,341 d 3.7 y | 740 d 2.0 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | Kisunla ケサンラ | Donanemab ドナネマブ(遺伝子組換え) | Eli Lilly Japan K.K. 日本イーライリリー(株) | Slowing the 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 active ingredient standard | 2024-07-02 | 2025-09-24 | 84 d 0.2 y | 365 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2024-09-24 | Kidparen キドパレン輸 | 医療用配合剤のため該当しない JP | Otsuka Pharmaceutical Factory, Inc. (株)大塚製薬工場 | Supplementation of water, electrolytes, calories, amino acids, and vitamins in patients with chronic renal failure (for use only in patients with or at a risk of hyperkalemia or hyperphosphatemia) for whom receiving oral or enteral nutrition is impossible or insufficient and the total parenteral nutrition is the only choice 経口・経腸管栄養補給が不能又は不十分で、経中心静脈栄養に頼らざるを得ない慢性腎不全患者(高カリウム血症、高リン血症の患者又はそのおそれのある患者に限る)に対する水分、電解質、カロリー、アミノ酸、ビタミン補給 | Other standard | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | 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) | Treatment of unresectable urothelial carcinoma 根治切除不能な尿路上皮癌 | New indication priority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Jakavi ジャカビ | Ruxolitinib phosphate ルキソリチニブリン酸塩 Orphan | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of graft-versus-host disease after hematopoietic stem cell transplantation (for use when steroid drugs are not sufficiently effective) 造血幹細胞移植後の移植片対宿主病(ステロイド剤の投与で効果不十分な場合) | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Fruzaqla フリュザクラ | Fruquintinib フルキンチニブ | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Treatment of unresectable advanced or recurrent colon or rectal cancer that has progressed after cancer chemotherapy がん化学療法後に増悪した治癒切除不能な進行・再発の結腸・直腸癌 | New active ingredient standard | 2023-11-08 | 2024-06-20 | 321 d 0.9 y | 96 d 0.3 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | Firdapse ファダプス | Amifampridine phosphate アミファンプリジンリン酸塩 | DyDo Pharma, Inc. ダイドーファーマ(株) | Improvement of muscle weakness in patients with Lambert-Eaton myasthenic syndrome ランバート・イートン筋無力症候群の筋力低下の改善 | New active ingredient orphanpriority | 2018-11-28 | 2009-12-23 | 2,127 d 5.8 y | 5,389 d 14.8 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | Evrysdi エブリスディドライ | Risdiplam リスジプラム Orphan | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of spinal muscular atrophy 脊髄性筋萎縮症 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Enosolid Semi Solid イノソリッド | 医療用配合剤のため該当しない JP | EN Otsuka Pharmaceutical Co., Ltd. イーエヌ大塚製薬(株) | Tube feeding, especially for patients with long-term oral feeding difficulties. It also generally can be used for nutrient retention for postoperative patients 一般に、手術後患者の栄養保持に用いることができるが、特に長期にわたり、経口的食事摂取が困難な場合の経管栄養補給に使用すること | Other standard | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Bimzelx ビンゼレックス | Bimekizumab ビメキズマブ(遺伝子組換え) | UCB Japan Co., Ltd. ユーシービージャパン(株) | Treatment of hidradenitis suppurativa 化膿性汗腺炎 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-09-24 | Augtyro オータイロ | Repotrectinib レポトレクチニブ | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Treatment of ROS1 fusion gene-positive unresectable advanced or recurrent non-small-cell lung cancer ROS1融合遺伝子陽性の切除不能な進行・再発の非小細胞肺癌 | New active ingredient standard | 2023-11-15 | 2025-01-13 | 314 d 0.9 y | 111 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2024-09-24 | Alyssa アリッサ | Estetrol hydrate/Drospirenone エステトロール水和物/ドロスピレノン | Fuji Pharma Co., Ltd. 富士製薬工業(株) | Treatment of dysmenorrhea 月経困難症 | New active ingredient standard | 2021-04-15 | 2021-05-19 | 1,258 d 3.4 y | 1,224 d 3.4 y | [1] [2] [3] [4] [5] |
| 2024-09-24 | Alaglio アラグリオ | Aminolevulinic acid hydrochloride アミノレブリン酸塩酸塩 Orphan | SBI Pharmaceuticals Co., Ltd. SBIファーマ(株) | Visualization of tumor tissues of the non-muscle invasive bladder cancer in transurethral resection of bladder tumor 経尿道的膀胱腫瘍切除術時における筋層非浸潤性膀胱癌の可視化 | New dosage orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-09-13 | Kostaive コスタイベ | mRNA encoding the spike protein of SARS-CoV-2 (Omicron JN.1 variant) SARS-CoV-2(オミクロン株JN.1)のスパイクタンパク質をコードするmRNA | Meiji Seika Pharma Co., Ltd. Meiji Seikaファルマ(株) | Prevention of disease caused by SARS-CoV-2 infection (COVID-19) SARS-CoV-2による感染症の予防 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-09-05 | Nuvaxovid ヌバキソビッド | SARS-CoV-2 rS (Omicron JN.1 variant) SARS-CoV-2 rS(オミクロン株JN.1) | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Prevention of disease caused by SARS-CoV-2 infection (COVID-19) SARS-CoV-2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.
Download: CSV (UTF-8). Other free lists: Japan new medical device approvals · PMDA consultation fees & timelines.
Content under the Public Data License 1.0 (PDL1.0) is used under PDL1.0 (compatible with CC BY 4.0). This site edits, reorganizes and translates the original materials. The English text is an unofficial translation; the Japanese originals prevail.
This site is independent. It is not affiliated with, endorsed by, or produced by PMDA, MHLW, the Digital Agency, the U.S. FDA or the European Medicines Agency. Information is provided "as is" for general information only and may be incomplete or out of date. It is not legal, regulatory or medical advice. Always check the official source before making decisions.
Last checked against official sources: .