Acalabrutinib
Also known as Calquence
ASTRAZENECA PLC AZN · Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; Untreated Chronic Lymphocytic Leukemia
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
3
From ClinicalTrials.gov
Latest FDA action
Approved
NDA210259,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; Untreated Chronic Lymphocytic Leukemia Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 210259 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 210259 (opens in a new tab)
- NDA 216387 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 216387 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 17 Sep 20193 linked trials
- Filed Completed
- Approved Current stageFirst approval 31 Oct 2017
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Acalabrutinib. Editors add each one with its source.
Filed application
No filed application is on record for Acalabrutinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Acalabrutinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05057494ClinicalTrials.gov record for NCT05057494 (opens in a new tab)MAJIC | A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Phase 3 | Active, not recruiting | 607 (actual) | 15 Jul 2027 (estimated) | No |
Publications listing MAJIC (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04075292ClinicalTrials.gov record for NCT04075292 (opens in a new tab) | Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia | Phase 3 | Active, not recruiting | 155 (actual) | 3 Jan 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04075292 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04075292
Serious adverse events (From first dose of study drug (Day 1) up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months).): Acalabrutinib 30 of 77; Chlorambucil Plus Rituximab 17 of 73 Source: ClinicalTrials.gov results for NCT04075292 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT04008706ClinicalTrials.gov record for NCT04008706 (opens in a new tab)ASSURE | Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients | Phase 3 | Completed | 552 (actual) | 4 Nov 2025 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04008706 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ASSURE Serious adverse events (Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)): Acalabrutinib TN Cohort 152 of 310; Acalabrutinib R/R Cohort 118 of 202; Acalabrutinib Prior BTKi Therapy Cohort 12 of 40 Source: ClinicalTrials.gov results for NCT04008706 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Calquence (EMEA/H/C/005299)
- Authorised
- Therapeutic area
- Leukemia, Lymphocytic, Chronic, B-Cell
- Marketing authorisation holder
- AstraZeneca AB
- Active substance (INN)
- acalabrutinib
- ATC code
- L01EL02
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Calquence (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 210259 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05057494 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04075292 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04008706 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA210259 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA216387 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.