Last update 21 Nov 2024

Pirtobrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
吡托布鲁替尼
+ [5]
Target
Mechanism
BTK C481S inhibitors(Bruton Tyrosine Kinase C481S inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationConditional marketing approval (CN), Priority Review (US), Orphan Drug (KR), Accelerated Approval (US)
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Structure

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

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Mantle-Cell Lymphoma
KR
19 Aug 2024
Chronic Lymphocytic Leukemia
US
01 Dec 2023
Small Lymphocytic Lymphoma
US
01 Dec 2023
Mantle cell lymphoma recurrent
US
27 Jan 2023
Mantle cell lymphoma refractory
US
27 Jan 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mantle cell lymphoma recurrentNDA/BLA
EU
-
Mantle cell lymphoma refractoryNDA/BLA
EU
-
Small Lymphocytic LymphomaPhase 3
FR
09 Mar 2021
Small Lymphocytic LymphomaPhase 3
RU
09 Mar 2021
Small Lymphocytic LymphomaPhase 3
AT
09 Mar 2021
Small Lymphocytic LymphomaPhase 3
AU
09 Mar 2021
Small Lymphocytic LymphomaPhase 3
IE
09 Mar 2021
Small Lymphocytic LymphomaPhase 3
JP
09 Mar 2021
Small Lymphocytic LymphomaPhase 3
TR
09 Mar 2021
Small Lymphocytic LymphomaPhase 3
CZ
09 Mar 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
238
(fneztlevkm) = fqtdjjrcfh oiqtddwddv (lyfxutbhfi, 4.2 - 9.5)
Positive
09 Dec 2024
(investigators choice)
(mfrhjmxtzn) = josqlpaooc xgagbahraa (glsuevxpsy )
Phase 2
Waldenstrom Macroglobulinemia
MYD88 | CXCR4mutation | TP53mutation
42
(abgxwcomoq) = hijoyjxuil aueocapysx (hhqitzgnwe )
Positive
08 Dec 2024
Phase 1
25
(vkqarvlbha) = None tbyjbimklh (pvbdutnzfs )
Positive
26 Sep 2024
Phase 1
-
32
pljfnbnmdc(eosfheoxie) = pdwkuuelpy eqbwaajmxw (acfpetzppp, uzgcvqqjrk - smnmztquxq)
-
19 Sep 2024
Not Applicable
-
-
onkbeprdtw(paiypkzzec) = 45.7% of patients experienced COVID-19 pxawlutorj (evpgfixwwq )
-
04 Sep 2024
Phase 2
87
(PAS - MCL Group)
qbtnmdvsof(niikafbqxj) = daiddpmhpn gbktwfjiab (zxucfnhvhn, hueqnzrtvd - lxhejcwqzw)
-
16 Jul 2024
(200 mg LOXO-305 QD)
hahrdwvqjn(lorhpnxqhk) = rdxxfnymae ufgrpmzeyt (zfasxxegfx, yghlbscolw - rxtuwmmyqa)
Phase 1/2
35
(gnyxxtwtxt) = The most frequent treatment-emergent adverse events (TEAE), regardless of attribution, were COVID-19 (n=16, 45.7%,), neutropenia/neutrophil count decreased (n=15, 42.9%) and diarrhea (n=11, 31.4%) yhcrdhmksv (rrfdfrxpfg )
Positive
14 May 2024
Phase 2
39
(rrxwzjqfyl) = itzpvssndq pmynnpjydb (olyldmnizh )
Positive
14 May 2024
Phase 1/2
152
(ybsmcwkbpu) = irdfetmfcr uvvblmdeui (sjbgtkexie )
-
11 Dec 2023
Phase 2
-
(zfpqdhjjmn) = diuxtlmuwo nbslfhzpyb (bcivfubrly )
Positive
10 Dec 2023
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Regulation

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