Data updated: May 26, 2026
JAYPIRCA (pirtobrutinib)
Bruton's Tyrosine Kinase Inhibitors Genetically Validated
Trial Activity: Growth 40 active trials
Orphan Drug Priority Review Accelerated Approval Fast Track
Oncology
Approved 2023-01-27
JAYPIRCA is indicated for the treatment of Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma.
How JAYPIRCA Works
Pirtobrutinib is a noncovalent inhibitor of Bruton’s tyrosine kinase (BTK). Unlike earlier covalent inhibitors, it binds reversibly to both wild-type BTK and BTK harboring C481 mutations. By blocking BTK signaling in the B-cell antigen receptor (BCR) and cytokine receptor pathways, pirtobrutinib inhibits the proliferation, trafficking, chemotaxis, and adhesion of malignant B-cells.
Development Insights
Eli Lilly and Company conducting 16 trials (29%)
53 indications explored (Broad Platform)
→ chronic lymphocytic leukemia (20 trials)
→ small lymphocytic lymphoma (15 trials)
→ healthy (11 trials)
3
Indications
--
Phase 3 Trials
2
Priority Reviews
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-01-27
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
JAYPIRCA Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2023 to 2025 · 2 indication expansions
What JAYPIRCA Treats
3 indicationsJAYPIRCA is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mantle Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Source: FDA Label
JAYPIRCA Target & Pathway
ProTarget
A kinase essential for B-cell development and signaling. BTK inhibitors block B-cell receptor signaling, making them highly effective in B-cell malignancies like chronic lymphocytic leukemia and mantle cell lymphoma.
JAYPIRCA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
2
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
2
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in JAYPIRCA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JAYPIRCA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to JAYPIRCA
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
CALQUENCE
ACALABRUTINIB MALEATE
AstraZeneca
Shared indications:
Chronic lymphocytic leukemiaSmall lymphocytic lymphoma
COPIKTRA
DUVELISIB
SECURA
Shared indications:
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
IMBRUVICA
IBRUTINIB
PHARMACYCLICS LLC
Shared indications:
Mantle Cell LymphomaChronic Lymphocytic Leukemia
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Clinical Trial Registry
55 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06588478 | 18877 2024-515689-15-01, J2N-MC-JZNX | Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT06721013 | 27294 J2N-MC-JZNZ | Ph 1, Ph 2 | recruiting | A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia |
| NCT06973187 | BGB-16673-304 2025-522860-34-00 | Ph 3 | recruiting | A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT04623541 EPCORE™ CLL-1 | GCT3013-03 2020-000848-57, NL74221.056.20 | Ph 1, Ph 2 | active not recruiting | Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome |
| NCT05529069 | 2021-1108 NCI-2022-07498 | Ph 2 | recruiting | Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients |
| NCT05536349 | 2021-0578 NCI-2022-07625 | Ph 2 | recruiting | Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) |
| NCT07342478 | LP-168-US-CLL301 ROCKET-CLL | Ph 3 | recruiting | ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL |
| NCT04666038 BRUIN CLL-321 results posted | 18073 J2N-OX-JZNN, LOXO-BTK-20020 | Ph 3 | active not recruiting | Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT06263491 | 2023-0413 NCI-2024-01325 | Ph 2 | recruiting | Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients |
| NCT07548450 MPOWER | HCI198712 | Ph 2 | not yet recruiting | Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER) |
| NCT06948786 | RG1125134 NCI-2025-02708, 20877 | Ph 2 | recruiting | Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial |
| NCT06252675 | 232516 NCI-2024-00054 | Ph 2 | recruiting | Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma |
| NCT05254743 BRUIN-CLL-314 | 18281 J2N-OX-JZNU, LOXO-BTK-20030 | Ph 3 | recruiting | A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT07218341 | 27296 J2N-MC-JZ03, J2N-MC-JZNY | Ph 4 | recruiting | A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT07162181 | 27295 J2N-MC-JZ02, 2024-517760-29-00 | Ph 2 | active not recruiting | Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers |
| NCT06522386 | 2024-0220 NCI-2024-06175 | Ph 2 | active not recruiting | GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma |
| NCT07516093 | NX-5948-306 2025-524145-27-00 | Ph 3 | not yet recruiting | Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL |
| NCT06553872 | MCC-22557 J2N-US-I010 | Ph 2 | recruiting | Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL |
| NCT05024045 | 18258 2021-000060-30, J3N-OX-JZRA | Ph 1 | active not recruiting | Study of Oral LOXO-338 in Patients With Advanced Blood Cancers |
| NCT06876662 | 27289 2024-517760-29-00, J2N-MC-JZ01 | Ph 4 | recruiting | A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma |
| NCT06876649 | 27202 2024-517760-29-00, J2N-MC-JZNY | Ph 4 | recruiting | A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib |
| NCT05990465 | PRO00050826 | Ph 1 | recruiting | LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies |
| NCT06466122 | OSU-22172 NCI-2024-04627 | Ph 2 | recruiting | Pirtobrutinib (LOXO-305) and Venetoclax for the Treatment of Patients With CLL or SLL Resistant to Covalent BTKi |
| NCT05677919 | MC210806 NCI-2022-09676, 22-004216 | Ph 2 | active not recruiting | Pirtobrutinib and Venetoclax With MRD Detection for Previously Untreated Chronic Lymphocytic Leukemia |
| NCT04965493 BRUIN CLL-322 | 18087 J2N-OX-JZNO, LOXO-BTK-20022 | Ph 3 | active not recruiting | A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) |
| NCT03740529 | 17539 2018-003340-24, J2N-OX-JZNA | Ph 1, Ph 2 | completed | A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL |
| NCT05023980 BRUIN CLL-313 | 18088 J2N-OX-JZNP, LOXO-BTK-20023 | Ph 3 | active not recruiting | A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT06333262 | 24-017 | Ph 2 | recruiting | Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia |
| NCT06043674 | 23-429 | Ph 2 | recruiting | Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation |
| NCT05317936 | 2021-0953 NCI-2022-02427 | Ph 1, Ph 2 | terminated | Pirtobrutinib (LOXO-305) Consolidation for MRD Eradication in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) Treated With Venetoclax |
| NCT07052695 | 25-277 | Ph 1, Ph 2 | recruiting | Mosunetuzumab for CLL MRD Clearance |
| NCT06390956 | HCI181739 | Ph 2 | recruiting | Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL) |
| NCT07255963 | 2025807 | Ph 2 | recruiting | Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL |
| NCT07231952 | 25-149 | Ph 2 | recruiting | A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) |
| NCT06967610 | 2025-0271 NCI-2025-03338 | Ph 2 | recruiting | Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). |
| NCT07220187 | S2504 NCI-2025-06717, S2504 | Ph 3 | not yet recruiting | Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial |
| NCT07207785 FIL_PUMA | FIL_PUMA | Ph 2 | not yet recruiting | PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma |
| NCT07122609 | pirto-R-Gemox | Ph 2 | not yet recruiting | Pirtobrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin With or Without Polatuzumab Vedotin in Covalent BTK Inhibitor-Pretreated Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT06812715 PIPOZA | 23/028 | Ph 2 | recruiting | Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib |
| NCT06839872 BOSS | D8220R00065 | Ph 2 | withdrawn | A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT04662255 BRUIN-MCL-321 | 18072 J2N-OX-JZNM, LOXO-BTK-20019 | Ph 3 | active not recruiting | Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) |
| NCT05734495 | 22-611 | Ph 2 | recruiting | Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia |
| NCT06165146 results posted | LOXO-BTK-20016 J2N-OX-JZNL | Ph 1 | completed | A Study of the Effects of Pirtobrutinib (LOXO-305) on Repaglinide (CYP2C8 Substrate) in Healthy Participants |
| NCT06215430 results posted | LOXO-BTK-20010 J2N-OX-JZNE | Ph 1 | completed | A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants |
| NCT06180980 results posted | LOXO-BTK-20009 J2N-MC-JZNK | Ph 1 | completed | A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants |
| NCT06215521 results posted | LOXO-BTK-20011 J2N-OX-JZNI | Ph 1 | completed | A Study to Evaluate the Effect of Pirtobrutinib (LOXO-305) on QTc Interval in Healthy Participants |
| NCT06180967 results posted | LOXO-BTK-20008 J2N-OX-JZND | Ph 1 | completed | A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Different Formulations of Midazolam in Healthy Participants |
| NCT06194214 results posted | LOXO-BTK-20021 J2N-OX-JZNT | Ph 1 | completed | A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy Participants |
| NCT06181006 results posted | LOXO-BTK-20017 J2N-OX-JZNS | Ph 1 | completed | A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants |
| NCT06190678 results posted | LOXO-BTK-20013 J2N-OX-JZNG | Ph 1 | completed | Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Kidney Function and Healthy Participants |
Showing 50 of 55 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JAYPIRCA FDA Label Details
Indications & Usage
FDA Label (PDF)JAYPIRCA is indicated for the treatment of Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma.
View full patent landscape →
7 OB patents · 2 families ·
151 international docs across 40 countries
JAYPIRCA Patents & Exclusivity
Latest Patent: Sep 2041
Exclusivity: Dec 2032
Patents (7 active)
US12109193
Expires Sep 14, 2041
US12268666
Expires Jul 29, 2039
US10918622
Expires Dec 16, 2036
US10695323
Expires Dec 16, 2036
US10464905
Expires Dec 16, 2036
US12220401
Expires Dec 16, 2036
US10342780
Expires Dec 16, 2036
Exclusivity
I-981
Until Dec 2028
NCE
Until Jan 2028
ODE-424
Until Jan 2030
ODE-451
Until Dec 2030
ODE-518
Until Dec 2032
I-981
Until Dec 2028
NCE
Until Jan 2028
ODE-424
Until Jan 2030
ODE-451
Until Dec 2030
ODE-518
Until Dec 2032
I-981
Until Dec 2028
NCE
Until Jan 2028
ODE-424
Until Jan 2030
ODE-451
Until Dec 2030
ODE-518
Until Dec 2032
I-981
Until Dec 2028
NCE
Until Jan 2028
ODE-424
Until Jan 2030
ODE-451
Until Dec 2030
ODE-518
Until Dec 2032
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for JAYPIRCA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 44 active patents
Trial Analysis
- • 55 total trials
- • Stage: Growth
Competitive Landscape
- • 19 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment