Jaypirca

(Pirtobrutinib)

ApprovedSmall molecule

Pirtobrutinib is used to treat certain types of blood cancers, specifically chronic lymphocytic leukemia and small lymphocytic lymphoma. It works by blocking a protein that helps cancer cells survive and grow.[2] Jaypirca is currently approved and in use across 18 indications[4].[1]

Jaypirca is one of 369 small molecule programs targeting Hepatic failure. It is currently in Approved.

Indications

Total Trials

Active Trials

368

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Hepatic FailureApproved

Non-Hodgkins LymphomaActive, not recruiting

Lymphoplasmacytic LymphomaActive, not recruiting

MacroglobulinemiaActive, not recruiting

LymphomaActive, not recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaActive, not recruiting

Non-Small Cell Lung CancerApproved

Mantle Cell LymphomaActive, not recruiting

Diffuse Large B-Cell LymphomaActive, not recruiting

Chronic Lymphocytic LeukemiaRecruiting

Hepatic FailureApproved

Approved

Non-Hodgkins LymphomaApproved

Active, not recruiting

Lymphoplasmacytic LymphomaPhase 2

Active, not recruiting

MacroglobulinemiaPhase 2

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerApproved

Approved

Mantle Cell LymphomaPhase 3

Active, not recruiting

Diffuse Large B-Cell LymphomaPhase 2

Active, not recruiting

Chronic Lymphocytic LeukemiaApproved

Recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Jaypirca

Eli Lilly

Approved

1 2

Velban

EEastern Cooperative Oncology Group

Preclinical

15 3

Oncaspar

SServier

Preclinical

15 4

Zofran

Novartis

Preclinical

2 5

Tafasitamab

Incyte

Preclinical

7 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

PEG-Intron

Merck & Co.

Preclinical

1 8

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—9

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

3 10

VP-16

FFundamenta Therapeutics, Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Treatment

NCT06466122

Q1 2027

Phase 2Recruiting

Mantle Cell Lymphoma

NCT06263491

Q2 2027

Phase 2Recruiting

Mantle Cell Lymphoma

NCT05529069

Phase 3Active, not recruiting

Chronic Lymphocytic Leukemia

NCT04666038

Q3 2027

Phase 1Recruiting

B-Cell Malignancies

NCT05990465

Phase 2Not yet recruiting

Diffuse Large B-Cell Lymphoma

NCT07122609

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia9 trials

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

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT06839872

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)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04666038·238 enrolled

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05023980·309 enrolled

Show 6 more trials

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05254743·662 enrolled

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

Recruiting·IInhye Ahn·Phase 2·NCT06333262·60 enrolled

Pirtobrutinib and Venetoclax With MRD Detection for Previously Untreated Chronic Lymphocytic Leukemia

Active, not recruiting·MMayo Clinic·Phase 2·NCT05677919·72 enrolled

Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05536349·60 enrolled

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

Recruiting·BBeOne Medicines·Phase 3·NCT06973187·500 enrolled

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

Recruiting· Eli Lilly logo

Eli Lilly·Approved·NCT07218341·150 enrolled

Mantle Cell Lymphoma8 trials

PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma

Not yet recruiting·FFondazione Italiana Linfomi - ETS·Phase 2·NCT07207785·56 enrolled

Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma

Recruiting·GGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea·Phase 2·NCT07285590·50 enrolled

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04662255·500 enrolled

Show 5 more trials

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06263491·50 enrolled

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05529069·30 enrolled

Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT06252675·30 enrolled

A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.

Recruiting·AAustralasian Leukaemia and Lymphoma Group·Phase 2·NCT05833763·42 enrolled

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

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06522386·50 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma6 trials

Pirtobrutinib (LOXO-305) Consolidation for MRD Eradication in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) Treated With Venetoclax

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT05317936·3 enrolled

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT06588478·249 enrolled

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)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04965493·600 enrolled

Show 3 more trials

A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Recruiting· Eli Lilly logo

Eli Lilly·Phase 4·NCT06876662·279 enrolled

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).

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06967610·40 enrolled

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

Recruiting·JJennifer Woyach·Phase 2·NCT07685717·50 enrolled

ART4 trials

A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06180980·20 enrolled

A Study to Evaluate the Effect of Pirtobrutinib (LOXO-305) on QTc Interval in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06215521·31 enrolled

A Study of the Effects of Pirtobrutinib (LOXO-305) on Repaglinide (CYP2C8 Substrate) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06165146·16 enrolled

Show 1 more trial

A Study of Two Different Formulations of Pirtobrutinib (LOXO-305) In Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06258174·28 enrolled

Interaction3 trials

A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06194214·16 enrolled

A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05176314·32 enrolled

A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Different Formulations of Midazolam in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06180967·15 enrolled

25 more indications

Function2 trials

Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Kidney Function and Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06190678·16 enrolled

Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06190691·36 enrolled

CLL/SLL2 trials

ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL

Not yet recruiting·NNewave Pharmaceutical Inc·Phase 3·NCT07342478·306 enrolled

A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL

Completed· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT03740529·803 enrolled

Treatment2 trials

Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT07255963·29 enrolled

Pirtobrutinib (LOXO-305) and Venetoclax for the Treatment of Patients With CLL or SLL Resistant to Covalent BTKi

Recruiting·KKerry Rogers·Phase 2·NCT06466122·30 enrolled

Blood Cancer2 trials

Study of Oral LOXO-338 in Patients With Advanced Blood Cancers

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT05024045·316 enrolled

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07162181·13 enrolled

Methotrexate1 trial

A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort)

Recruiting·TTongji Hospital·Phase 2·NCT07350850·110 enrolled

Lymphoma1 trial

Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL)

Recruiting·UUniversity of Utah·Phase 2·NCT06390956·23 enrolled

B-cell Malignancies1 trial

LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

Recruiting·MMedical College of Wisconsin·Phase 1·NCT05990465·12 enrolled

Adult1 trial

A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06181006·24 enrolled

Lymphoplasmacytic Lymphoma1 trial

A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07231952·40 enrolled

Multiple Sclerosis1 trial

A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis

Withdrawn· Eli Lilly logo

Eli Lilly·Phase 2·NCT06104683

Oral1 trial

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

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06215430·16 enrolled

Richter Transformation1 trial

Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial

Not yet recruiting·SSWOG Cancer Research Network·Phase 3·NCT07220187·102 enrolled

First-line1 trial

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

Recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT07428707·30 enrolled

Macroglobulinemia1 trial

Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia

Recruiting·—·Phase 2·NCT05734495·42 enrolled

Randomized1 trial

Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06553872·60 enrolled

Richter's Transformation1 trial

Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation

Recruiting·CChristine Ryan·Phase 2·NCT06043674·70 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Pirtobrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin With or Without Polatuzumab Vedotin in Covalent BTK Inhibitor-Pretreated Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Not yet recruiting·RRuijin Hospital·Phase 2·NCT07122609·22 enrolled

MRD1 trial

Mosunetuzumab for CLL MRD Clearance

Recruiting·IInhye Ahn·Phase 1/2·NCT07052695·40 enrolled

Follicular Lymphoma1 trial

Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial

Recruiting·UUniversity of Washington·Phase 2·NCT06948786·22 enrolled

Chronic Lymphocytic Leukaemia1 trial

Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib

Recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT06812715·40 enrolled

Cancer1 trial

Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

Approved for marketing· Eli Lilly logo

Eli Lilly··NCT05172700

Relapsed/Refractory Chronic Lymphocytic Leukemia1 trial

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

Active, not recruiting· Genmab logo

Genmab·Preclinical·NCT04623541·194 enrolled

Mantle Cell Lymphoma (MCL)1 trial

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

Not yet recruiting·HHenan Cancer Hospital·Phase 2·NCT07684950·45 enrolled

Immune Thrombocytopenia (ITP)1 trial

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

Recruiting· Eli Lilly logo

Eli Lilly·Preclinical·NCT06721013·68 enrolled

Unspecified1 trial

A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

Recruiting· Eli Lilly logo

Eli Lilly·Phase 4·NCT06876649·787 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 27, 2023

JAYPIRCA

NDA NDA216059

Sources

References

[1]
ClinicalTrials.gov — 59 trial records for Pirtobrutinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Jaypirca drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pirtobrutinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pirtobrutinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216059). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Jaypirca. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Pirtobrutinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: BTK Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eli Lilly

Patent Landscape[6]

Patent Cliff

Dec 16, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12220401Dec 16, 2036

10695323Dec 16, 2036

10464905Dec 16, 2036

10918622Dec 16, 2036

10342780Dec 16, 2036

2 more patents

12268666Jul 29, 2039

12109193Sep 14, 2041

Key Publications[7]

Pirtobrutinib in Relapsed/Refractory Mantle Cell Lymphoma: BRUIN

N Engl J MedNov 16, 2023DOI: 10.1056/NEJMoa2311400

Jaypirca

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Chronic Lymphocytic Leukemia9 trials

Mantle Cell Lymphoma8 trials

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma6 trials

ART4 trials

Interaction3 trials

Function2 trials

CLL/SLL2 trials

Treatment2 trials

Blood Cancer2 trials

Methotrexate1 trial

Lymphoma1 trial

B-cell Malignancies1 trial

Adult1 trial

Lymphoplasmacytic Lymphoma1 trial

Multiple Sclerosis1 trial

Oral1 trial

Richter Transformation1 trial

First-line1 trial

Macroglobulinemia1 trial

Randomized1 trial

Richter's Transformation1 trial

Diffuse Large B-Cell Lymphoma1 trial

MRD1 trial

Follicular Lymphoma1 trial

Chronic Lymphocytic Leukaemia1 trial

Cancer1 trial

Relapsed/Refractory Chronic Lymphocytic Leukemia1 trial

Mantle Cell Lymphoma (MCL)1 trial

Immune Thrombocytopenia (ITP)1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

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