Pirtobrutinib

Generic Name: Pirtobrutinib

Brand Names: Jaypirca

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₁F_₄N_₅O_₃

CAS Number: 2101700-15-4

Unique Ingredient Identifier: JNA39I7ZVB

Background: Pirtobrutinib is a small molecule and a highly selective non-covalent inhibitor of Bruton’s tyrosine kinase (BTK). Its high selectivity has been associated with lower discontinuation rates due to adverse events and a lower incidence of atrial fibrillation. Unlike BTK covalent inhibitors, such as ibrutinib, that bind to the cysteine 481 (Cys481) amino acid within the active site of BTK, the inhibitory activity of pirtobrutinib is maintained even in the presence of Cys481 mutations. Although the mechanisms of resistance to covalent BTK inhibitors have not been fully elucidated, it appears that the presence of Cys481 mutations is the most common reason for resistance to covalent BTK inhibitors. However, other mutations may confer resistance to non-covalent BTK inhibitors such as pirtobrutinib.

In January 2023, the use of pirtobrutinib for the treatment of relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy was approved under the FDA's Accelerated Approval pathway.

Indication: Pirtobrutinib is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

Associated Conditions: Refractory Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma

Clinical Trials

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

Phase 3

Not yet recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: BGB-16673
Drug: Pirtobrutinib

First Posted Date: 2025-05-15

Last Posted Date: 2025-05-15

Lead Sponsor: BeiGene

Target Recruit Count: 500

Registration Number: NCT06973187

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

Phase 2

Not yet recruiting

Conditions: Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Recurrent Follicular Lymphoma
Refractory Follicular Lymphoma

Interventions: Drug: Pirtobrutinib
Biological: Mosunetuzumab
Procedure: Biospecimen Collection
Procedure: Biopsy Procedure
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Other: Questionnaire Administration

First Posted Date: 2025-04-29

Last Posted Date: 2025-04-29

Lead Sponsor: University of Washington

Target Recruit Count: 22

Registration Number: NCT06948786

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

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

Phase 4

Not yet recruiting

Conditions: Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma

Interventions: Drug: Pirtobrutinib

First Posted Date: 2025-03-14

Last Posted Date: 2025-04-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 279

Registration Number: NCT06876662

Locations: 🇺🇸
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸
The Emory Clinic, Atlanta, Georgia, United States

and more 32 locations

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

Phase 4

Not yet recruiting

Conditions: Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma

Interventions: Drug: Pirtobrutinib

First Posted Date: 2025-03-14

Last Posted Date: 2025-04-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 279

Registration Number: NCT06876649

Locations: 🇺🇸
Swedish Cancer Institute, Seattle, Washington, United States
🇺🇸
University of California Medical Center, San Francisco, California, United States
🇺🇸
Sylvester Comprehensive Cancer Center, Miami, Florida, United States

and more 33 locations

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

Phase 2

Not yet recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Pirtobrutinib
Drug: Acalabrutinib

First Posted Date: 2025-02-21

Last Posted Date: 2025-02-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 60

Registration Number: NCT06839872

Locations: 🇺🇸
Research Site, Tacoma, Washington, United States

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

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Pirtobrutinib

First Posted Date: 2025-02-06

Last Posted Date: 2025-05-11

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 40

Registration Number: NCT06812715

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
🇦🇺
Alfred Hospital, Melbourne, Victoria, Australia
🇦🇺
Monash Medical Centre, Melbourne, Victoria, Australia

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Phase 1

Not yet recruiting

Conditions: Immune Thrombocytopenia (ITP)

Interventions: Drug: Pirtobrutinib
Drug: Placebo

First Posted Date: 2024-12-06

Last Posted Date: 2025-04-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 58

Registration Number: NCT06721013

Locations: 🇺🇸
Bleeding and Clotting Disorders Institute, Peoria, Illinois, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States

and more 1 locations

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

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Pirtobrutinib

First Posted Date: 2024-09-19

Last Posted Date: 2025-04-18

Lead Sponsor: Loxo Oncology, Inc.

Target Recruit Count: 249

Registration Number: NCT06588478

Locations: 🇺🇸
Ironwood Cancer & Research Centers, Chandler, Arizona, United States
🇺🇸
City of Hope National Medical Center, Irvine, California, United States
🇺🇸
Palo Alto Medical Foundation Research Institute (PAMFRI), Palo Alto, California, United States

and more 133 locations

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

Phase 2

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Pirtobrutinib
Drug: Brexucabtagene Autoleucel

First Posted Date: 2024-08-14

Last Posted Date: 2025-05-13

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 60

Registration Number: NCT06553872

Locations: 🇺🇸
Stanford Cancer Center, Stanford, California, United States
🇺🇸
Univ of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

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

Phase 2

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Pirtobrutinib
Drug: Rituximab
Drug: Venetoclax

First Posted Date: 2024-07-26

Last Posted Date: 2025-02-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT06522386

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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