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
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as CALQUENCE (DIN 02535696) under ATC L01EL02 ACALABRUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 1, 2023 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as CALQUENCE (DIN 02491788) under ATC L01EL02 ACALABRUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Jul 25, 2025 | Oct 2, 2019 | health-canada-dpd |
| EU EMA | — | Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a 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 6 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 |
|---|---|---|---|---|---|---|---|---|
| NCT05950997 | A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL | recruiting | N/A | 89 | The First Affiliated Hospital with Nanjing Medical UniversityOTHER | 1 | May 9, 2024 | clinicaltrials |
| NCT05205252 | A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.(ARIA) |