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Drug

Pirtobrutinib

Approved medicine
ResearchActive indication expansion

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.

RxNorm2629338ChEMBLCHEMBL4650485ATCL01EL05UNIIJNA39I7ZVB
44
Active clinical trials
6
Regulatory events
Latest activity
beta

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

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Clinical trial2026-11-01Primary completion · ClinicalTrials.gov

A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

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

Clinical trial2026-10-22Results expected Q1 2030 · ClinicalTrials.gov

Lilly's BTK drug Jaypirca joins first-line options in US

Industry2026-10-05pharmaphorum

Genmab details ovarian cancer data; Lilly's Jaypirca gets a label expansion

Industry2026-10-05Manufacturing · Endpoints News

STAT+: Lilly’s Jaypirca approved as first-line CLL therapy

Regulatory2026-10-05Regulatory news · STAT News

FDA approves expanded indication for Lilly’s Jaypirca

Regulatory2026-10-05Regulatory news · Pharmaceutical Technology

Indication expansion: PIRTOBRUTINIB (NDA216059)

Regulatory2026-10-02FDA

A Multicenter Phase 2 Study of Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Clinical trial2026-10-01Results expected Q3 2028 · ClinicalTrials.gov

Indication expansion: PIRTOBRUTINIB (NDA216059)

Regulatory2025-12-02FDA

Label change: PIRTOBRUTINIB (NDA216059)

Regulatory2024-06-04FDA

Indication expansion: PIRTOBRUTINIB (NDA216059)

Regulatory2023-12-01FDA

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
ATC codes
L01EL05
UNII
JNA39I7ZVB
Regulatory jurisdictions
fdaema

Regulatory timeline

6 events

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.

Approval / market entry confirmed across FDA and EMA (2023-01-27 → 2023-12-01)
Earliest approval
2023-01-27
Latest approval
2026-10-02
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 5 events
2026-10-02Indication expansion
Indication expansion: PIRTOBRUTINIB (NDA216059)
Evidence ↗
2025-12-02Indication expansion
Indication expansion: PIRTOBRUTINIB (NDA216059)
Evidence ↗
2024-06-04Label change
Label change: PIRTOBRUTINIB (NDA216059)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-10-30Conditional marketing authorisationMulti-authority
Conditional marketing authorisation: 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 ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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 2026
44
Active studies
35
Recruiting
12
Late-stage (III+)
13
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 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies

CompletedPH IEli Lilly and Companyn=272026

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
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.