Drug · Small Molecule
Pirtobrutinib
CI-DRUG-00000771Explore in graph →CHEMBL4650485 Approved
Regulatory
Approvals (7)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2025-12-02 (see label) | approved | Dec 2, 2025 | openfda |
| US FDA | — | Efficacy supplement 2023-12-01 (see label) | approved | Dec 1, 2023 | openfda |
| US FDA | Mantle Cell Lymphoma | Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. | approved | Jan 27, 2023 | openfda |
| US FDA | Chronic Lymphocytic Leukemia | . This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 45 | 27 | 10 | 50 | 7 | CA, EU, US | Jan 27, 2023 | Mar 15, 2019 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 36 | 22 | 10 | 41 | 1 | US | Jan 27, 2023 | Mar 15, 2019 |
| Leukemia | Approved | Phase 4 | 23 | 16 | 8 | 28 | 1 | US | Jan 27, 2023 | Mar 15, 2019 |
| Multiple Myeloma | Phase1 | Phase 1 | 0 | 0 | 0 | 1 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (52)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06252675 | Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma | recruiting | Phase 2 | 30 | University of California, San FranciscoOTHER | 1 | Sep 28, 2026 | clinicaltrials |
| NCT06973187 | A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |