Drug · Small Molecule
Acalabrutinib
CI-DRUG-00000736Explore in graph →CHEMBL3707348 Approved
Regulatory
Approvals (15)
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 2026-02-19 (see label) | approved | Feb 19, 2026 | openfda |
| US FDA | — | Efficacy supplement 2026-02-19 (see label) | approved | Feb 19, 2026 | openfda |
| US FDA | — | Efficacy supplement 2025-01-16 (see label) | approved | Jan 16, 2025 | openfda |
| US FDA | — | Efficacy supplement 2025-01-16 (see label) | approved | Jan 16, 2025 | openfda |
| US |
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 15 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 | 79 | 30 | 19 | 113 | 15 | CA, EU, US | Oct 31, 2017 | Jan 30, 2014 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 53 | 22 | 6 | 71 | 3 | US | Oct 31, 2017 | Jan 30, 2014 |
| Leukemia | Phase4 | Phase 4 | 33 | 18 | 11 | 46 | 0 | — | — | Jan 30, 2014 |
| Malignant Central Nervous System Neoplasm | Phase2 | Phase 2 | 5 | 1 | 0 | 5 | 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 (117)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT02029443 | ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia | active not recruiting | Phase 1 / Phase 2 | 306 | Acerta Pharma BVINDUSTRY | 3 | May 5, 2026 | clinicaltrials |
| NCT04978584 | Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study |