PMDA · MHLW · monthly list
All drugs approved in Japan in December 2025, in English.
Last updated: 2026-10-02 · 22 approvals
Japan approved 22 drugs in December 2025 (approval date: 2025-12-22): 12 new active ingredient, 3 new indication, 2 new route, 2 new dosage, 1 biosimilar, 1 new combination, 1 new dosage form. Median lag vs FDA for this month: 2.4 years (871 days) (n=9).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-22 | Zynyz ジニイズ | Retifanlimab レチファンリマブ(遺伝子組換え) Orphan | Incyte Biosciences Japan G.K. インサイト・バイオサイエンシズ・ジャパン(同) | Treatment of unresectable advanced or recurrent squamous cell carcinoma of the anal canal 切除不能な進行・再発の肛門管扁平上皮癌 | New active ingredient orphanpriority | 2023-03-22 | 2024-04-19 | 1,006 d 2.8 y | 612 d 1.7 y | [1] [2] [3] [4] [5] |
| 2025-12-22 | Zurzuvae ザズベイ | Zuranolone ズラノロン | Shionogi & Co., Ltd. 塩野義製薬(株) | Treatment of depression うつ病・うつ状態 | New active ingredient standard | 2023-08-04 | — | 871 d 2.4 y | — | [1] [2] [3] [4] |
| 2025-12-22 | Yselty イセルティ | Linzagolix choline リンザゴリクスコリン | Kissei Pharmaceutical Co., Ltd. キッセイ薬品工業(株) | Alleviation of menorrhagia, lower abdominal pain, backache, and anemia that are associated with uterine fibroids 子宮筋腫に基づく下記諸症状の改善 過多月経、下腹痛、腰痛、貧血 | New active ingredient standard | — | 2022-06-14 | — | 1,287 d 3.5 y | [1] [2] [3] [4] |
| 2025-12-22 | Ustekinumab BS ウステキヌマブBS | Ustekinumab [Ustekinumab biosimilar 4] ウステキヌマブ(遺伝子組換え)[ウステキヌマブ後続4] | Nipro Corporation ニプロ(株) | A biosimilar indicated for the treatment of the following diseases in patients who have not sufficiently responded to conventional therapies: plaque psoriasis and psoriatic arthritis 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 | Biosimilar standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Upneeq Mini アップニークミニ | Oxymetazoline hydrochloride オキシメタゾリン塩酸塩 | Santen Pharmaceutical Co., Ltd. 参天製薬(株) | Treatment of acquired blepharoptosis 後天性眼瞼下垂 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Tecentriq テセントリク | Atezolizumab アテゾリズマブ(遺伝子組換え) Orphan | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of unresectable thymic carcinoma 切除不能な胸腺癌 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Sephience セピエンス | Sepiapterin セピアプテリン | PTC Therapeutics K.K. PTC セラピューティクス(株) | Treatment of phenylketonuria フェニルケトン尿症 | New active ingredient orphanpriority | 2025-07-28 | 2025-06-19 | 147 d 0.4 y | 186 d 0.5 y | [1] [2] [3] [4] [5] |
| 2025-12-22 | Rybrofaz リブロファズ | Amivantamab/ Vorhyaluronidase alfa 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) | Treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) gene exon 20 insertion mutation-positive non-small cell lung cancer and unresectable advanced or recurrent epidermal growth factor receptor (EGFR) gene 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および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 combination standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Ravicti ラヴィクティ | Glycerol phenylbutyrate フェニル酪酸グリセロール Orphan | OrphanPacific, Inc. (株)オーファンパシフィック | Treatment of urea cycle disorders 尿素サイクル異常症 | New active ingredient orphanpriority | 2013-02-01 | 2015-11-26 | 4,707 d 12.9 y | 3,679 d 10.1 y | [1] [2] [3] [4] [5] |
| 2025-12-22 | PreemieFort Enteral プリミーフォート経腸用 | (1) (2) Human milk/ Calcium glycerophosphate/ Calcium gluconate hydrate/Calcium chloride hydrate/Anhydrous Sodium Citrate/Potassium citrate/Magnesium monohydrogen phosphate/Zinc sulfate hydrate/Sodium chloride/Copper sulfate (3) Human milk 12人乳/グリセロリン酸カルシウム/グルコン酸カルシウム水和物/塩化カルシウム水和物/無水クエン酸ナトリウム/クエン酸カリウム/リン酸一水素マグネシウム/硫酸亜鉛水和物/塩化ナトリウム/硫酸銅 3人乳 | Clinigen K.K. クリニジェン(株) | Nutritional management of neonates and infants with failure to thrive, such as very low birth weight infants. (3) A drug with a new active ingredient indicated for the nutritional management of neonates and infants with failure to thrive, such as very low birth weight infants (1) (2) 極低出生体重児等の体重増加不全を呈する新生児及び乳児の栄養管理 (3) 極低出生体重児等の体重増加不全を呈する新生児及び乳児の栄養管理 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Opsumit オプスミット小児用分 | Macitentan マシテンタン Orphan | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of pulmonary arterial hypertension. (3) A drug with a new additional pediatric dosage indicated for the treatment of pulmonary arterial hypertension 肺動脈性肺高血圧症 | New dosage form orphanspecific-usepriority | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Minjuvi ミンジュビ | Tafasitamab タファシタマブ(遺伝子組換え) Orphan | Incyte Biosciences Japan G.K. インサイト・バイオサイエンシズ・ジャパン(同) | Treatment of relapsed or refractory follicular lymphoma 再発又は難治性の濾胞性リンパ腫 | New active ingredient orphanpriority | 2020-07-31 | 2021-08-26 | 1,970 d 5.4 y | 1,579 d 4.3 y | [1] [2] [3] [4] [5] |
| 2025-12-22 | 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) | Treatment of relapsed or refractory follicular lymphoma 再発又は難治性の濾胞性リンパ腫 | New route standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Kerendia ケレンディア | Finerenone フィネレノン | Bayer Yakuhin, Ltd. バイエル薬品(株) | Treatment of chronic heart failure (for use only in patients receiving standard treatment of chronic heart failure) 慢性心不全 ただし、慢性心不全の標準的な治療を受けている患者に限る。 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Inluriyo イムルリオ | Imlunestrant tosilate イムルネストラントトシル酸塩 | Eli Lilly Japan K.K. 日本イーライリリー(株) | Treatment of hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative inoperable or recurrent breast cancer with ESR1 mutation that has progressed after endocrine therapy 内分泌療法後に増悪したESR1遺伝子変異を有す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 active ingredient standard | 2025-09-25 | 2026-01-09 | 88 d 0.2 y | 18 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2025-12-22 | Exdensur エキシデンサー | Depemokimab デペモキマブ(遺伝子組換え) | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Treatment of bronchial asthma (for use only in patients with severe or intractable bronchial asthma whose asthmatic responses are uncontrollable with conventional therapies) and chronic rhinosinusitis with nasal polyps (for use only in patients who have not responded sufficiently to conventional treatments) ○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重症又は難治の患者に限る) ○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 active ingredient standard | 2025-12-16 | 2026-02-12 | 6 d 0.0 y | 52 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2025-12-22 | Elzonris I.V. エルゾンリス | Tagraxofusp タグラキソフスプ(遺伝子組換え) | Nippon Shinyaku Co., Ltd. 日本新薬(株) | Treatment of blastic plasmacytoid dendritic cell neoplasm 芽球性形質細胞様樹状細胞腫瘍 | New active ingredient orphanpriority | 2018-12-21 | 2021-01-07 | 2,558 d 7.0 y | 1,810 d 5.0 y | [1] [2] [3] [4] [5] |
| 2025-12-22 | Ekterly エクテリー | Sebetralstat セベトラルスタット Orphan | KalVista Pharmaceuticals Ltd. | Treatment of acute attacks of hereditary angioedema 遺伝性血管性浮腫の急性発作 | New active ingredient orphanpriority | 2025-07-03 | 2025-09-17 | 172 d 0.5 y | 96 d 0.3 y | [1] [2] [3] [4] [5] |
| 2025-12-22 | Dupixent デュピクセント | Dupilumab デュピルマブ(遺伝子組換え) | Sanofi K.K. サノフィ(株) | Treatment of bronchial asthma (for use only in patients with severe or intractable bronchial asthma whose asthmatic responses are uncontrollable with conventional therapies) 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重症又は難治の患者に限る) | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Carboplatin カルボプラチン | Carboplatin カルボプラチン | Viatris Healthcare G.K. ヴィアトリス・ヘルスケア(同) | Treatment of ovarian cancer 卵巣癌 | New route standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Avarept アバレプト | Motugivatrep モツギバトレプ | Senju Pharmaceutical Co., Ltd. 千寿製薬(株) | Treatment of dry eye ドライアイ | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2025-12-22 | Adzynma アジンマ | Apadamtase alfa/ Cinaxadamtase alfa アパダムターゼ アルファ(遺伝子組換え)/シナキサダムターゼ アルファ(遺伝子組換え) | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Treatment of congenital thrombotic thrombocytopenic purpura 先天性血栓性血小板減少性紫斑病 | New dosage 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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