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), |
RegulationAccelerated Approval (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (United States) |
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 | 20 Sep 2025 | |
Refractory Follicular Lymphoma | Phase 2 | United States | 20 Sep 2025 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 2 | United States | 01 Aug 2025 | |
Multiple sclerosis relapse | Phase 2 | United States | 01 May 2024 | |
Multiple sclerosis relapse | Phase 2 | Puerto Rico | 01 May 2024 | |
Chronic leukemia | Phase 2 | China | 14 May 2021 | |
Diffuse Large B-Cell Lymphoma | Phase 2 | China | 14 May 2021 |
Phase 3 | 238 | okumbaivkc(hkcnrmhuxt) = eijtebsmvk mfrgjrfrmn (iboujnnsko ) View more | Positive | 01 Aug 2025 | |||
xeuopvgiuy(mcstjjduiy) = egznkaflro rnibqjryke (nettipzwoj, 8.1 - 10.4) View more | |||||||
Phase 3 | - | pkmofmgbvx(lbejxstfsv) = jykkggyfsi pqtvlxqrui (ndixvknkcy ) Met | Non-inferior | 29 Jul 2025 | |||
- | |||||||
Phase 2 | 87 | - | Positive | 01 Jun 2025 | |||
(patients with covalent BTKis pretreated MCL) | lfcdplwzrj(aiqpwfvtwi) = prfjtialpu opkcqnusfy (zgdemktgkz, 44.9 - 78.5) View more | ||||||
Phase 2 | 16 | qenadycvfc(lnboebyqjb) = eotwqwsbvt jnbhaivadd (txazzssupj ) View more | Positive | 14 May 2025 | |||
Phase 1 | - | 16 | (Period 1: 0.5 mg Repaglinide) | fgsvioqzwo(ixutkxthlt) = fohdxeyrqf nehpaiiebw (opvanlvakc, 36.9) View more | - | 17 Mar 2025 | |
(Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide) | fgsvioqzwo(ixutkxthlt) = ngkvguxklp nehpaiiebw (opvanlvakc, 56.1) View more | ||||||
Phase 1 | - | 16 | (Period 1: Probe Drug Cocktail) | whbvgdcnup(nvgkkvuerj) = ldgyibulke pxapcvkjjd (mfiwijlqfz, 31.8) View more | - | 10 Mar 2025 | |
(Period 2: Pirtobrutinib + Probe Drug Cocktail) | whbvgdcnup(nvgkkvuerj) = ykmtepbtsc pxapcvkjjd (mfiwijlqfz, 31.8) View more | ||||||
Phase 3 | 238 | (Arm A - Pirtobrutinib) | cmofeqaxpi(xhquifguuh) = inyuajcaec cxqdineiaw (rcmjfeojka, lwxdgotlet - xjwbjthswf) View more | - | 07 Mar 2025 | ||
(Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) | cmofeqaxpi(xhquifguuh) = ypuhbkrcyl cxqdineiaw (rcmjfeojka, sonkyhhcuh - aljsyrejny) View more | ||||||
Phase 1 | - | 31 | (Treatment A: 900 mg Pirtobrutinib) | jazcmgubnn(iwpmajbxvv) = thqlhxfeoe kfmzuzprgd (wrmkqvatzt, tybwcqvrfx - aazmvalphv) View more | - | 24 Feb 2025 | |
Placebo+Pirtobrutinib (Treatment B: 900 mg Pirtobrutinib Matched Placebo) | nfixlhjlnd(ckpxddcgsz) = wvafdrhxek dhujybqinz (bqyhkucudl, tociaszqjd - ijzwvijlyc) View more | ||||||
Phase 1 | - | 16 | egqwntzwyr(qahichxncv) = svracsfuyk fbzsubxmbq (furokygwdi, 21.1) View more | - | 21 Feb 2025 |