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Drug

Pirtobrutinib

Approved · EMA
Late-stage development

Also known as Jaypirca, (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, 1h-pyrazole-4-carboxamide, 5-amino-3-(4-(((5-fluoro-2-methoxybenzoyl)amino)methyl)phenyl)-1-((1s)-2,2,2-trifluoro-1-methylethyl)-, 5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2s)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide.

RxNorm2629338ChEMBLCHEMBL4650485UNIIJNA39I7ZVB
45
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib

Clinical trial2026-07-21Results expected Q1 2030 · ClinicalTrials.gov

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Clinical trial2026-07-17Results expected Q4 2027 · ClinicalTrials.gov

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Clinical trial2026-07-10Results expected Q2 2028 · ClinicalTrials.gov

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Clinical trial2026-07-07Results expected Q4 2027 · ClinicalTrials.gov

A Phase 2 Trial of Single-Agent Pirtobrutinib for Elderly Patients With CLL

Clinical trial2026-07-06Results expected Q4 2027 · ClinicalTrials.gov

A Prospective Phase 2 Study of Lisaftoclax Plus Pirtobrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma After Failure of BTK-Targeted Therapy

Clinical trial2026-07-06Results expected Q4 2028 · ClinicalTrials.gov

Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia

Clinical trial2026-06-25Results expected Q2 2028 · ClinicalTrials.gov

GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma

Clinical trial2026-06-24Results expected Q1 2027 · ClinicalTrials.gov

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Clinical trial2026-06-23Results expected Q2 2030 · ClinicalTrials.gov

Lilly oncology chief went from ‘extremely nervous’ to ‘blown away’ by new Jaypirca CLL data

Industry2026-06-13Fierce Pharma

Approval: Jaypirca (EMA)

Regulatory2023-10-30EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pirtobrutinib
Aliases & brands
Jaypirca(s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide1h-pyrazole-4-carboxamide, 5-amino-3-(4-(((5-fluoro-2-methoxybenzoyl)amino)methyl)phenyl)-1-((1s)-2,2,2-trifluoro-1-methylethyl)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2s)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide
RxNorm CUI
2629338
ChEMBL ID
CHEMBL4650485
UNII
JNA39I7ZVB
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-10-30
Latest approval
2023-10-30
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-10-30Approval
Approval: Jaypirca (EMA)
Indication: Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s… Show full indication

Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have been previously treated with a BTK inhibitor.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

60 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
60
registered trials across all phases
LATEST COMPLETION 2025
45
Active studies
35
Recruiting
12
Late-stage (III+)
12
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 60
Early Phase 11Phase 113Phase 1 / 25Phase 229Phase 39Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib

RecruitingPH IVEli Lilly and Companyn=7872032

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

RecruitingPH IVEli Lilly and Companyn=1502032

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-18001 With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

RecruitingPH IVEli Lilly and Companyn=2792032

A Randomized Phase III Study of Pirtobrutinib Plus R-CHOP vs. R-CHOP for Participants With Previously Untreated Richter Transformation (PIRAMID)

Not yet recruitingPH IIISWOG Cancer Research Networkn=1022036

A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Not yet recruitingPH IIINurix Therapeutics, Inc.n=6202032

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

CompletedPH I/IILoxo Oncology, Inc.n=8032025

A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single and Multiple Doses of Pirtobrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

CompletedPH ILoxo Oncology, Inc.n=322022

An Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-305 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects

CompletedPH IEli Lilly and Companyn=362021

A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Compare the PK of Pirtobrutinib (LOXO-305) Tablets

CompletedPH IEli Lilly and Companyn=282021

A Phase I, Open-label, Fixed-sequence, Drug Interaction Study to Investigate the Effect of Single and Multiple Oral Doses of LOXO-305 on the Pharmacokinetics of Multiple Oral Doses of Digoxin (P-Glycoprotein Substrate) in Healthy Subjects

CompletedPH IEli Lilly and Companyn=162021

An Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-305 Administered to Fasted Renally Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects

CompletedPH IEli Lilly and Companyn=162021
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.