Last update 27 Aug 2025

Pirtobrutinib

Overview

Basic Info

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)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC22H21F4N5O3
InChIKeyFWZAWAUZXYCBKZ-NSHDSACASA-N
CAS Registry2101700-15-4

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
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
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
LymphomaNDA/BLA
Canada
01 Mar 2025
Chronic lymphocytic leukaemia refractoryNDA/BLA
European Union
27 Feb 2025
Recurrent Chronic Lymphoid LeukemiaNDA/BLA
European Union
27 Feb 2025
Recurrent Follicular LymphomaPhase 2
United States
20 Sep 2025
Refractory Follicular LymphomaPhase 2
United States
20 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
United States
01 Aug 2025
Multiple sclerosis relapsePhase 2
United States
01 May 2024
Multiple sclerosis relapsePhase 2
Puerto Rico
01 May 2024
Chronic leukemiaPhase 2
China
14 May 2021
Diffuse Large B-Cell LymphomaPhase 2
China
14 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
238
okumbaivkc(hkcnrmhuxt) = eijtebsmvk mfrgjrfrmn (iboujnnsko )
Positive
01 Aug 2025
xeuopvgiuy(mcstjjduiy) = egznkaflro rnibqjryke (nettipzwoj, 8.1 - 10.4)
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)
Phase 2
16
qenadycvfc(lnboebyqjb) = eotwqwsbvt jnbhaivadd (txazzssupj )
Positive
14 May 2025
Phase 1
-
16
(Period 1: 0.5 mg Repaglinide)
fgsvioqzwo(ixutkxthlt) = fohdxeyrqf nehpaiiebw (opvanlvakc, 36.9)
-
17 Mar 2025
(Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide)
fgsvioqzwo(ixutkxthlt) = ngkvguxklp nehpaiiebw (opvanlvakc, 56.1)
Phase 1
-
16
(Period 1: Probe Drug Cocktail)
whbvgdcnup(nvgkkvuerj) = ldgyibulke pxapcvkjjd (mfiwijlqfz, 31.8)
-
10 Mar 2025
(Period 2: Pirtobrutinib + Probe Drug Cocktail)
whbvgdcnup(nvgkkvuerj) = ykmtepbtsc pxapcvkjjd (mfiwijlqfz, 31.8)
Phase 3
238
(Arm A - Pirtobrutinib)
cmofeqaxpi(xhquifguuh) = inyuajcaec cxqdineiaw (rcmjfeojka, lwxdgotlet - xjwbjthswf)
-
07 Mar 2025
(Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab)
cmofeqaxpi(xhquifguuh) = ypuhbkrcyl cxqdineiaw (rcmjfeojka, sonkyhhcuh - aljsyrejny)
Phase 1
-
31
(Treatment A: 900 mg Pirtobrutinib)
jazcmgubnn(iwpmajbxvv) = thqlhxfeoe kfmzuzprgd (wrmkqvatzt, tybwcqvrfx - aazmvalphv)
-
24 Feb 2025
(Treatment B: 900 mg Pirtobrutinib Matched Placebo)
nfixlhjlnd(ckpxddcgsz) = wvafdrhxek dhujybqinz (bqyhkucudl, tociaszqjd - ijzwvijlyc)
Phase 1
-
16
egqwntzwyr(qahichxncv) = svracsfuyk fbzsubxmbq (furokygwdi, 21.1)
-
21 Feb 2025
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