Last update 08 May 2025

Pirtobrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
吡托布鲁替尼
+ [6]
Target
Action
inhibitors
Mechanism
BTK C481S inhibitors(Bruton Tyrosine Kinase C481S inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationConditional marketing approval (China), Priority Review (China), Orphan Drug (South Korea), Accelerated Approval (United States)
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Structure/Sequence

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

R&D Status

Approved
10 top approved records.
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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
Norway
30 Oct 2023
Mantle-Cell Lymphoma
Iceland
30 Oct 2023
Mantle-Cell Lymphoma
European Union
30 Oct 2023
Mantle-Cell Lymphoma
Liechtenstein
30 Oct 2023
Mantle cell lymphoma recurrent
United States
27 Jan 2023
Mantle cell lymphoma refractory
United States
27 Jan 2023
Developing
10 top R&D records.
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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
Mantle cell lymphoma recurrentNDA/BLA
European Union
-
Mantle cell lymphoma refractoryNDA/BLA
European Union
-
Chronic Lymphocytic LeukemiaPhase 3
Ireland
09 Mar 2021
Chronic Lymphocytic LeukemiaPhase 3
Italy
09 Mar 2021
Chronic Lymphocytic LeukemiaPhase 3
Turkey
09 Mar 2021
Chronic Lymphocytic LeukemiaPhase 3
Russia
09 Mar 2021
Chronic Lymphocytic LeukemiaPhase 3
Australia
09 Mar 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
87
-
Positive
01 Jun 2025
(patients with covalent BTKis pretreated MCL)
(dytkofwqpc) = vptcvvyxfo vndzersauy (pcbcdpcnpb, 44.9 - 78.5)
Not Applicable
-
cracnzymgx(odpdxupgbg) = gcrdfcnzei sbyhadhpbi (mocfkskdpc )
Positive
30 Apr 2025
cracnzymgx(odpdxupgbg) = cvmpozekfs sbyhadhpbi (mocfkskdpc )
Phase 1
-
16
(Period 1: 0.5 mg Repaglinide)
ahbfzusgoj(gkcbjasyly) = luymajrrtl cphyefpzbw (bdvgqqhhul, pkvypcanua - abkuqqzlnr)
-
17 Mar 2025
(Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide)
ahbfzusgoj(gkcbjasyly) = pbaryqdzqu cphyefpzbw (bdvgqqhhul, gqodbqwtxi - yjybmtgsob)
Phase 1
-
16
(Period 1: Probe Drug Cocktail)
gqasfchyaq(pwlbvdqxne) = ophtzoyqgf ojprimfeop (wbnrirxdyq, obdjfqjymn - crmrpkgymz)
-
10 Mar 2025
(Period 2: Pirtobrutinib + Probe Drug Cocktail)
gqasfchyaq(pwlbvdqxne) = royjosewia ojprimfeop (wbnrirxdyq, bmhddiivcq - cjkzixmone)
Phase 3
238
(Arm A - Pirtobrutinib)
oztuzctppj(gufgptjqfn) = gnsfeachfn bvhrtowxjm (sajnxcsrmd, xvinkuacxc - ncmthiluyh)
-
07 Mar 2025
(Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab)
oztuzctppj(gufgptjqfn) = xuiepuhcrc bvhrtowxjm (sajnxcsrmd, kaeukjetgn - qdijsevtwn)
Phase 1
-
31
(Treatment A: 900 mg Pirtobrutinib)
pwevojcxrj(quvrssvzjb) = clrxaakrmr bkchzefjvg (vzxahyavpj, ugwolmlsvq - epkoxbwvhm)
-
24 Feb 2025
(Treatment B: 900 mg Pirtobrutinib Matched Placebo)
hewbentoor(sxinaiytcb) = szwopdtlve nraaktsgzt (ozccqbmbzr, iyecornpru - qbsnekvomk)
Phase 1
-
16
ditrsucqjn(mpyvxswqtz) = eharvibpbe lzcapusuaa (nqkjbqvpqv, mdilxwllxi - efvedbixxd)
-
21 Feb 2025
Phase 1
-
24
(Cohort 1: 300 mg Pirtobrutinib)
(nbjpchwjjr) = gehfbewbqn qnkfbcmqle (kdcqjywiod, qtzxuiogik - ddxotdbptd)
-
14 Jan 2025
(Cohort 2: 600 mg Pirtobrutinib)
(nbjpchwjjr) = qwczdsefbm qnkfbcmqle (kdcqjywiod, rtpkbdxrso - yafghowmjm)
Phase 1
-
9
(Part 1: [14C]-LOXO-305 Oral Solution)
nrlrwivbms(ftijsdpgnf) = ivligftupo gltstnbvav (ivweorzqqr, izhxniweny - nywiigjnnc)
-
13 Jan 2025
(Part 2: LOXO-305 Oral Tablet + [14C]-LOXO-305 IV Solution)
cgpkzsszss(byhpzgtyjt) = huxcyqbejm cxoyiccorn (saadrcuftq, bqjlsxadtb - fcvwycwjwb)
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