Last update 24 Aug 2026

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
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Conditional marketing approval (China)
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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
Refractory Small Lymphocytic Lymphoma
Australia
05 Mar 2026
Chronic lymphocytic leukaemia refractory
United States
02 Dec 2025
Recurrent Chronic Lymphoid Leukemia
United States
02 Dec 2025
Lymphoma
Canada
01 Oct 2025
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
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Follicular LymphomaPhase 2
United States
17 Nov 2025
Refractory Follicular LymphomaPhase 2
United States
17 Nov 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
United States
11 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
China
11 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
Denmark
11 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
France
11 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
Italy
11 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
Poland
11 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
South Korea
11 Sep 2025
Purpura, Thrombocytopenic, IdiopathicPhase 2
Spain
11 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
253
nkboarxacw(muibsawhqu) = Any-grade infection occurred in 59.9% of pts; neutropenia in 18.3% and grade ≥3 bleeding in 2.4%. Any-grade hypertension occurred in 10.7% of pts and atrial fibrillation/flutter was reported in 2.8%. yiknhjnvyg (lqhxywmgjz )
Positive
29 May 2026
Phase 3
253
(CLL-313)
natukwmebu(rgjhllmzbl) = mnmdjgablj xenmoqtqaf (xeizbefyvi, 93.3 - 99.3)
Positive
21 May 2026
(CLL-314)
natukwmebu(rgjhllmzbl) = szscuxhehu xenmoqtqaf (xeizbefyvi, 91.5 - 99.1)
Phase 3
306
ijkxridyjh(tcoozgmmpm) = eofwargxte qinllecglj (hiaonmaucx )
Positive
12 May 2026
ijkxridyjh(tcoozgmmpm) = dsakwrdprd qinllecglj (hiaonmaucx )
Phase 3
282
dwlcuoxiql(jzhtzpwjdf) = vsqatwxhxx rpshfzuchd (zjnspqvewl )
Positive
12 May 2026
Bendamustine plus Rituximab
dwlcuoxiql(jzhtzpwjdf) = sgsyqboyyg rpshfzuchd (zjnspqvewl )
Not Applicable
208
kaanaenkpu(uxipgkpxjv) = Infections accounted for 41% and hematologic toxicities for 28% of all grade ≥3 AEs. Four AEs of grade 5 occurred, however deaths were dominantly attributable to disease progression. sdlibijsix (crhxnfnkmk )
Positive
12 May 2026
Current standard of care (SoC)
Not Applicable
50
(Observation)
ituqqnplmk(gocbdgaora) = reported in 11 patients: 3 had an infection, 3 had neutropenia; febrile neutropenia, diarrhea, chest pain, pulmonary toxicity, and increased transaminase levels were recorded in 1 patient each. One patient had fungal pneumonia, and 1 patient had an episode of atrial fibrillation (grade not reported). nqooulwqth (dpudkjruwi )
Positive
12 May 2026
Phase 2
60
zuiutefwsn(veiktwzlva) = nqeuazqpwn dczrhystrf (axhhcvbujk )
Positive
12 May 2026
Phase 1/2
80
hxbuhcvlef(njakxering) = unrelated to treatment lhfsbkalcg (ceruattxil )
Positive
01 May 2026
(previous covalent BTK inhibitors)
Phase 3
282
kevbqqmysd(dscvxepttu) = urdrvxjqaj vwqsycxrol (qotazuqety, 87.6 - 96.5)
Positive
20 Feb 2026
Bendamustine plus rituximab (BendaR)
kevbqqmysd(dscvxepttu) = zgrhmkredr vwqsycxrol (qotazuqety, 61.5 - 78.1)
Phase 3
662
pycgisunob(lxucdewvvl) = yncvnhvbbk bwhdajzlfv (ayfarpjkbl, 82.9 - 90.4)
Non-inferior
20 Feb 2026
pycgisunob(lxucdewvvl) = kkzixvglgs bwhdajzlfv (ayfarpjkbl, 73.7 - 82.9)
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Regulation

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