Drug · Small Molecule
Zanubrutinib
CI-DRUG-00000742Explore in graph →CHEMBL3936761 Approved
Regulatory
Approvals (23)
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 | — | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). • This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.accelerated | approved | Jun 10, 2025 | openfda |
| US FDA | Mantle Cell Lymphoma | Mantle cell lymphoma (MCL) who have received at least one prior therapy. | approved | Jun 10, 2025 | openfda |
| US FDA | Waldenstrom Macroglobulinemia | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM).accelerated | approved | Jun 10, 2025 | openfda |
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 | 80 | 43 | 14 | 114 | 23 | CA, EU, US | Nov 14, 2019 | Sep 4, 2014 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 53 | 31 | 9 | 76 | 12 | US | Nov 14, 2019 | 2016-10 |
| Leukemia | Phase3 | Phase 3 | 22 | 11 | 5 | 27 | 0 | — | — | Jun 29, 2016 |
| Malignant Central Nervous System Neoplasm | Phase2 | Phase 2 | 3 | 3 | 0 | 6 | 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 (121)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06504199 | Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma(ZGR) | active not recruiting | Phase 2 | 39 | Institute of Hematology & Blood Diseases Hospital, ChinaOTHER | 1 | May 13, 2026 | clinicaltrials |
| NCT07261163 | Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma |