pirtobrutinib
Trade name: Jaypirca
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Jan 27, 2023
Clinical trial activity
56 trials · 29 clinical orgs · 2 marketing orgs
Phase 1
19
Phase 2
36
Phase 3
7
Phase 4
3
Earliest trial started Nov 16, 2018 (NCT03740529)
Timeline
2010s
- Jan 1, 2018
Loxo Oncology — Earliest Phase 1 Sponsor(trial)
2020s
- Aug 28, 2020
Orphan Drug Designation
- Jan 1, 2021
- Jan 1, 2021
Loxo Oncology — Earliest Phase 3 Sponsor(trial)
- Jan 27, 2023
Eli Lilly — Earliest FDA Approval
- Jan 27, 2023
Loxo Oncology — Marketing Organization
- Jan 27, 2023
Eli Lilly — NDA Secondary Org
- Jan 27, 2023
Eli Lilly — NDA Organization
Indications
Approved for
Studied for
- Burkitt Lymphoma · Phase 1
- Healthy Volunteers · Phase 1
- Hematologic Neoplasms · Phase 2
- Hepatic Insufficiency · Phase 1
- Leukemia · Phase 2
- Leukemia, B-Cell · Phase 3
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 4
- Leukemia, Lymphoid · Phase 3
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Mantle-Cell · Phase 3
- Lymphoma, Non-Hodgkin · Phase 4
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 3
- Multiple Myeloma · Phase 1
- Multiple Sclerosis · Phase 2
- Renal Insufficiency · Phase 1
- Thrombocytopenia · Phase 1/Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
- Tyrosine-protein kinase BTKANTAGONIST
BTK antagonist
- Tyrosine-protein kinase BTKINHIBITOR
Tyrosine-protein kinase BTK inhibitor
Approval history
- approvedPriority reviewAcceleratedFast trackJan 27, 2023
Chemistry & pharmacology
Loading structure…
SMILES
COc1ccc(F)cc1C(=O)NCc1ccc(-c2nn([C@@H](C)C(F)(F)F)c(N)c2C(N)=O)cc1- Mol. weight
- 479.43 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4650485 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07220187 | Phase 3 | May 2, 2026 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07218341 | Phase 4 | Mar 31, 2026 | Eli Lilly |
| NCT07207785 | Phase 2 | Feb 1, 2026 | Gruppo Italiano Studio Linfomi |
| NCT06522386 | Phase 2 | Dec 1, 2025 | University of Texas at Houston |
| NCT07052695 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2025 | Genentech, Harvard University |
| NCT07255963 | Phase 2 | Nov 30, 2025 | Soochow University |
| NCT06948786 | Phase 2 | Nov 17, 2025 | Eli Lilly, University of Washington |
| NCT07231952 | Phase 2 | Nov 11, 2025 | AbbVie, Eli Lilly, Memorial Sloan-Kettering Cancer Center |
| NCT07285590 | Phase 2 | Sep 30, 2025 | Eli Lilly, Evidenze Health España (CRO), Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, University of Barcelona |
| NCT06973187 | Phase 3 | Sep 4, 2025 | BeOne Medicines |
| NCT07162181 | Phase 2 | Aug 7, 2025 | Eli Lilly |
| NCT07122609 | Phase 2 | Aug 5, 2025 | Jiao Tong University |
| NCT06967610 | Phase 2 | Jul 15, 2025 | Eli Lilly, University of Texas at Houston |
| NCT06839872 | Phase 2 | Jun 30, 2025 | AstraZeneca, Eli Lilly |
| NCT06812715 | Phase 2 | May 31, 2025 | Eli Lilly, Peter MacCallum Cancer Centre |
| NCT06876649 | Phase 4 | Apr 30, 2025 | Eli Lilly |
| NCT06876662 | Phase 4 | Apr 30, 2025 | Eli Lilly |
| NCT06721013 | Phase 1/Phase 2 (Phase 2) | Mar 31, 2025 | Eli Lilly |
| NCT06390956 | Phase 2 | Dec 31, 2024 | Eli Lilly, University of Utah |
| NCT06466122 | Phase 2 | Dec 31, 2024 | Ohio State University |
Showing 20 of 56 trials
Page 1 / 3
Organizations
Research & Development (29)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eli Lilly | For profit | 33 | 18 | 5 | 2020 |
| Loxo Oncology | For profit | 27 | 12 | 4 | 2018 |
| University of Texas at Houston | Academic/Hospital | 6 | 6 | 1 | 2022 |
| Harvard University | Academic/Hospital | 3 | 3 | 1 | 2023 |
| Genentech | For profit | 2 | 0 | 1 | 2024 |
| AbbVie | For profit | 1 | 0 | 1 | 2025 |
| Adaptive Biotechnologies | For profit | 1 | 0 | 1 | 2024 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2025 |
| Australasian Leukaemia and Lymphoma Group | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Bankhead-Coley Florida Biomedical Research Program | Government | 1 | 0 | 1 | 2024 |
| BeOne Medicines | For profit | 1 | 1 | 1 | 2025 |
| Evidenze Health España (CRO) | For profit | 1 | 0 | 1 | 2025 |
| Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Gruppo Italiano Studio Linfomi | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Jiao Tong University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Medical College of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 1 | 1 | 1 | 2025 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2026 |
| Ohio State University | Academic/Hospital | 1 | 1 | 1 | 2024 |
29 organizations
Page 1 / 2
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Eli Lilly | For profit | NDA2 | Jan 27, 2023 |
| Eli Lilly | For profit | NDA | Jan 27, 2023 |
| Loxo Oncology | For profit | MKTG | Jan 27, 2023 |
| Loxo Oncology | For profit | SYN | Jan 27, 2023 |