PMDA · MHLW · monthly list
All drugs approved in Japan in March 2025, in English.
Last updated: 2026-10-02 · 22 approvals
Japan approved 22 drugs in March 2025 (approval date: 2025-03-27): 8 new indication, 7 new active ingredient, 3 new dosage form, 1 biosimilar, 1 new route, 1 new dosage, 1 other. Median lag vs FDA for this month: 2.9 years (1,064 days) (n=7).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-03-27 | Venclexta ベネクレクスタ | Venetoclax ベネトクラクス Orphan | AbbVie GK アッヴィ(同) | Treatment of relapsed or refractory mantle cell lymphoma 再発又は難治性のマントル細胞リンパ腫 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Ustekinumab BS ウステキヌマブBS | Ustekinumab [ustekinumab biosimilar 3] ウステキヌマブ(遺伝子組換え)[ウステキヌマブ後続3] | Celltrion Healthcare Japan K.K. セルトリオン・ヘルスケア・ジャパン(株) | A biosimilar indicated for the treatment of the following disease 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] |
| 2025-03-27 | 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). (2)(3) Drugs with a new indication and a new dosage in an additional dosage form for the maintenance therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). (4) A drug with a new indication and a new dosage for the maintenance therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments) (1) 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) (2) (3) 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) (4) 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) | New route standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Tivdak テブダック | Tisotumab vedotin チソツマブ ベドチン(遺伝子組換え) | Genmab K.K. ジェンマブ(株) | Treatment of advanced or recurrent cervical cancer that has progressed after cancer chemotherapy がん化学療法後に増悪した進行又は再発の子宮頸癌 | New active ingredient standard | 2021-09-20 | 2025-03-28 | 1,284 d 3.5 y | 1 d earlier Japan first | [1] [2] [3] [4] [5] |
| 2025-03-27 | Tibsovo ティブソボ | Ivosidenib イボシデニブ Orphan | Nihon Servier Co., Ltd. 日本セルヴィエ(株) | Treatment of IDH1 mutation-positive acute myeloid leukemia IDH1遺伝子変異陽性の急性骨髄性白血病 | New active ingredient orphanpriority | 2018-07-20 | 2023-05-04 | 2,442 d 6.7 y | 693 d 1.9 y | [1] [2] [3] [4] [5] |
| 2025-03-27 | Tevimbra I.V. テビムブラ | Tislelizumab チスレリズマブ(遺伝子組換え) | BeiGene Japan GK BeiGene Japan(同) | Treatment of unresectable advanced or recurrent esophageal cancer 根治切除不能な進行・再発の食道癌 | New active ingredient standard | 2024-03-13 | 2023-09-15 | 379 d 1.0 y | 559 d 1.5 y | [1] [2] [3] [4] [5] |
| 2025-03-27 | 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) mutation-positive non-small cell lung cancer 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 indication standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Rivaluen LA リバルエンLA | Rivastigmine リバスチグミン | Towa Pharmaceutical Co., Ltd. 東和薬品(株) | Indicated for inhibiting progression of symptoms of dementia in patients with mild and moderate Alzheimer's disease 軽度及び中等度のアルツハイマー型認知症における認知症症状の進行抑制 | New dosage form standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | 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 nephrotic syndrome (frequently relapsing or steroid-dependent nephrotic syndrome) ネフローゼ症候群(頻回再発型あるいはステロイド依存性) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Prevymis プレバイミス | Letermovir レテルモビル | MSD K.K. MSD(株) | Prophylaxis of cytomegalovirus disease in organ transplantation. (2) Drugs with a new pediatric dosage in an additional dosage form indicated for the prophylaxis of cytomegalovirus disease in allogeneic hematopoietic stem cell transplantation. )] (1) 臓器移植におけるサイトメガロウイルス感染症の発症抑制 (2) 同種造血幹細胞移植におけるサイトメガロウイルス感染症の発症抑制 | New dosage form orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Otezla オテズラ | Apremilast アプレミラスト | Amgen K.K. アムジェン(株) | Treatment of palmoplantar pustulosis in patients who have not responded sufficiently to local treatment 局所療法で効果不十分な掌蹠膿疱症 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Omvoh オンボー | Mirikizumab ミリキズマブ(遺伝子組換え) | Eli Lilly Japan K.K. 日本イーライリリー(株) | Treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments). (2)(3) Drugs with a new indication, a new dosage, and other characteristics for the treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments). (4)(5) Drugs with a new indication and a new dosage in an additional dosage form for the treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments) (1) 中等症から重症の活動期クローン病の治療(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治療(既存治療で効 果不十分な場合に限る) (4) (5) 中等症から重症の活動期クローン病の治療(既存治療で効 果不十分な場合に限る) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Livmarli リブマーリ | Maralixibat chloride マラリキシバット塩化物 | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis アラジール症候群及び進行性家族性肝内胆汁うっ滞症における胆汁うっ滞に伴うそう痒 | New active ingredient orphanpriority | 2021-09-29 | 2022-12-09 | 1,275 d 3.5 y | 839 d 2.3 y | [1] [2] [3] [4] [5] |
| 2025-03-27 | Lazcluze ラズクルーズ | Lazertinib mesilate hydrate ラゼルチニブメシル酸塩水和物 | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer 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 active ingredient standard | 2024-08-19 | 2025-01-20 | 220 d 0.6 y | 66 d 0.2 y | [1] [2] [3] [4] [5] |
| 2025-03-27 | Imfinzi イミフィンジ | Durvalumab デュルバルマブ(遺伝子組換え) Orphan | AstraZeneca K.K. アストラゼネカ(株) | Maintenance treatment of limited-stage small cell lung cancer following definitive chemoradiation therapy 限局型小細胞肺癌における根治的化学放射線療法後の維持療法 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | 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 adult-onset Still's disease in patients who have not responded sufficiently to conventional treatments 既存治療で効果不十分な成人発症スチル病 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | 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 chronic obstructive pulmonary disease (for use only in patients who have not responded sufficiently to conventional treatments) 慢性閉塞性肺疾患(既存治療で効果不十分な患者に限る) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Daichirona ダイチロナ | mRNA encoding the spike protein of SARS-CoV-2 SARS-CoV-2のスパイクタンパク質をコードするmRNA | Daiichi Sankyo Company, Limited 第一三共(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 dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Carbostar カーボスター透析剤 | 医療用配合剤のため該当しない JP | Yoshindo Inc. (株)陽進堂 | Hemodialysis in patients with chronic renal failure (use in any of the following cases: • When the patient’s blood sugar level is not controlled well with sugarless dialysate. • When dialysate with a high calcium concentration may cause hypercalcemia) 慢性腎不全における透析型人工腎臓の灌流液として、以下の要因を持つものに用いる。 ・無糖の透析液では、血糖値管理の困難な場合 ・カルシウム濃度の高い透析液では、高カルシウム血症を起こすおそれのある場合 | Other standard | — | — | — | — | [1] [2] [3] |
| 2025-03-27 | Camzyos カムザイオス | Mavacamten マバカムテン | Bristol-Myers Squibb K.K. ブリストル・マイヤーズスクイブ(株) | Treatment of symptomatic obstructive hypertrophic cardiomyopathy 閉塞性肥大型心筋症 | New active ingredient orphanpriority | 2022-04-28 | 2023-06-26 | 1,064 d 2.9 y | 640 d 1.8 y | [1] [2] [3] [4] [5] |
| 2025-03-27 | Beyonttra ビヨントラ | Acoramidis hydrochloride アコラミジス塩酸塩 | Alexion Pharma GK アレクシオンファーマ(同) | Treatment of transthyretin cardiac amyloidosis (wild-type and hereditary) トランスサイレチン型心アミロイドーシス(野生型及び変異型) | New active ingredient standard | 2024-11-22 | 2025-02-10 | 125 d 0.3 y | 45 d 0.1 y | [1] [2] [3] [4] [5] |
| 2025-03-27 | Bepio Wash ベピオウォッシュ | Benzoyl peroxide 過酸化ベンゾイル | Maruho Co., Ltd. マルホ(株) | Treatment of acne vulgaris 尋常性ざ瘡 | New dosage form 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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