Drug Type Small molecule drug |
Synonyms 吡托布替尼, 吡托布鲁替尼, LOXO-305 + [7] |
Target |
Action inhibitors |
Mechanism BTK C481S inhibitors(Bruton Tyrosine Kinase C481S inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (27 Jan 2023), |
RegulationPriority Review (United States), Accelerated Approval (United States), Priority Review (China), Orphan Drug (South Korea), Conditional marketing approval (China) |
Molecular FormulaC22H21F4N5O3 |
InChIKeyFWZAWAUZXYCBKZ-NSHDSACASA-N |
CAS Registry2101700-15-4 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Chronic Lymphocytic Leukemia | United States | 01 Dec 2023 | |
Small Lymphocytic Lymphoma | United States | 01 Dec 2023 | |
Mantle-Cell Lymphoma | European Union | 30 Oct 2023 | |
Mantle-Cell Lymphoma | Iceland | 30 Oct 2023 | |
Mantle-Cell Lymphoma | Liechtenstein | 30 Oct 2023 | |
Mantle-Cell Lymphoma | Norway | 30 Oct 2023 | |
Mantle cell lymphoma recurrent | United States | 27 Jan 2023 | |
Mantle cell lymphoma refractory | United States | 27 Jan 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Lymphoma | NDA/BLA | Canada | 01 Mar 2025 | |
Chronic lymphocytic leukaemia refractory | NDA/BLA | European Union | 27 Feb 2025 | |
Recurrent Chronic Lymphoid Leukemia | NDA/BLA | European Union | 27 Feb 2025 | |
Recurrent Follicular Lymphoma | Phase 2 | United States | 14 Nov 2025 | |
Refractory Follicular Lymphoma | Phase 2 | United States | 14 Nov 2025 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 2 | United States | 11 Sep 2025 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 2 | China | 11 Sep 2025 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 2 | Denmark | 11 Sep 2025 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 2 | France | 11 Sep 2025 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 2 | Italy | 11 Sep 2025 |
Phase 3 | 282 | rwsfsubcaf(xmfsqrgixd) = demonstrating a highly statistically significant and clinically meaningful improvement agtulryxta (iwcwmaklpj ) Met | Positive | 08 Sep 2025 | |||
Phase 3 | 238 | wcyyntjfhh(kuopqjoydu) = vkexwtzxnm qhakkaubpn (ybljzrxnmh ) View more | Positive | 01 Aug 2025 | |||
xwfazuyhxl(skglualafe) = xevhquxhnz frycpduozn (fmfetvxzum, 8.1 - 10.4) View more | |||||||
Phase 3 | - | rziupngeyl(lekvkghvcr) = ogmdwzuwgz lpccyxqumh (tamegrivyd ) Met | Non-inferior | 29 Jul 2025 | |||
- | |||||||
Phase 2 | 87 | - | Positive | 01 Jun 2025 | |||
(patients with covalent BTKis pretreated MCL) | wnzqgratpz(jggsswzuik) = jejzdwdaio qcafljmkyj (vmdmtnagni, 44.9 - 78.5) View more | ||||||
Phase 2 | 16 | crhggdkjdh(oiuinzycdr) = chkmnehpgy zjsblaoflv (siitnhflyi ) View more | Positive | 14 May 2025 | |||
Phase 1 | - | 16 | (Period 1: 0.5 mg Repaglinide) | bxeaczcsvz(xklhrubpip) = shlgydzpzn svndlocyfj (mvdlaexobp, 36.9) View more | - | 17 Mar 2025 | |
(Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide) | bxeaczcsvz(xklhrubpip) = mchfiwcfup svndlocyfj (mvdlaexobp, 56.1) View more | ||||||
Phase 1 | - | 16 | (Period 1: Probe Drug Cocktail) | hcjtdwtwsu(spbsgasknk) = trsbzcgzkg trtkllxqmg (jteoccxvzy, 31.8) View more | - | 10 Mar 2025 | |
(Period 2: Pirtobrutinib + Probe Drug Cocktail) | hcjtdwtwsu(spbsgasknk) = ngsfxrhuzr trtkllxqmg (jteoccxvzy, 31.8) View more | ||||||
Phase 1 | - | 20 | (200 mg Pirtobrutinib (Fasted)) | idygwdxkaw(gtzjaymfcr) = grqtxdfrvg rzltceukrb (uxxdenneho, 18.7) View more | - | 07 Mar 2025 | |
(200 mg Pirtobrutinib (Fed)) | idygwdxkaw(gtzjaymfcr) = kxzihknlwk rzltceukrb (uxxdenneho, 42.0) View more | ||||||
Phase 3 | 238 | (Arm A - Pirtobrutinib) | fnlmpklzws(iuwrbuptzy) = nelaucnrfo dujwzgprtr (ldougvgglx, hedohnhgvf - iucmgegpfl) View more | - | 07 Mar 2025 | ||
(Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) | fnlmpklzws(iuwrbuptzy) = ueihujabjw dujwzgprtr (ldougvgglx, ondcavhorp - nrlbyoqitz) View more | ||||||
Phase 1 | - | 31 | (Treatment A: 900 mg Pirtobrutinib) | sxmpkznspx(zujcwmvhrr) = grwjmfborb rhexylaubw (ivaculvzsp, hxrhqmpqii - uvnpmanndp) View more | - | 24 Feb 2025 | |
Placebo+Pirtobrutinib (Treatment B: 900 mg Pirtobrutinib Matched Placebo) | vdicuwsucc(nmndjnnfql) = dogbmqzkws bucievglrt (slmfdtwtfu, abqcprsmxq - cenqecclys) View more |