Acalabrutinib clinical trials
Acalabrutinib is named as an intervention in 49 current clinical trials in our USA, Spain, Italy, UK, Poland, France, Australia, China, Israel, Czechia, Germany, Canada, Brazil, Taiwan, Belgium, South Korea, Netherlands, Sweden, Austria, Denmark, Japan, Turkey, Switzerland, Portugal, Mexico, Ireland, Singapore, Egypt, Norway and India registers. 19 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Acerta Pharma BV (15). The most-studied condition is Chronic Lymphocytic Leukemia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial, 1 with a site in Ireland.
Where Acalabrutinib is approved
All regulators →Of the three regulators tracked here, the first to approve Acalabrutinib was the US, on 31 Oct 2017. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of lymphoplasmacytic lymphoma (21 Mar 2016, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Acalabrutinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Acalabrutinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 1 Jul 2036 (US 9796721).
- Latest patent on the drug substance itself: 1 Jul 2036 (US 9796721).
- Exclusivity D-200: New dosing schedule: use with venetoclax as a new combination regimen for the treatment ofadult patients with chronic lymphocytic leukemia …, until 19 Feb 2029.
- Exclusivity I-960: New indication: in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell ly…, until 16 Jan 2028.
- Exclusivity ODE-274: Orphan drug exclusivity: indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphom…, until 21 Nov 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Acalabrutinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Acalabrutinib works
All drug targets →- Tyrosine-protein kinase BTK inhibitor InhibitorTarget: BTK Bruton tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Diffuse large B-cell lymphomaPhase 3
- Richter transformationPhase 2
- Waldenstrom macroglobulinemiaPhase 2
- Autoimmune hemolytic anemiaPhase 2
- Follicular lymphomaPhase 2
- Graft versus host diseasePhase 2
- Head and neck squamous cell carcinomaPhase 2
- LeukemiaPhase 2
- Lymphoid leukemiaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3707348, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8912, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Acalabrutinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Acalabrutinib. 3 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Acalabrutinib with bendamustine and rituximab for untreated mantle cell lymphoma NICE TA1184 | Recommended | 19 Aug 2026 | Current |
| Acalabrutinib with venetoclax with or without obinutuzumab for untreated chronic lymphocytic leukaemia NICE TA1185 | Optimised | 19 Aug 2026 | Current |
| Acalabrutinib for treating chronic lymphocytic leukaemia NICE TA689 | Optimised | 21 Apr 2021 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Acalabrutinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: CalquenceEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Acalabrutinib
- ChEMBL
- CHEMBL3707348
- DrugBank
- DB11703
- PubChem CID
- 71226662
- CAS number
- 1420477-60-6
- FDA UNII
- I42748ELQW
- Wikidata
- Q23668732
- Wikipedia
- Acalabrutinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Acalabrutinib
49 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Acalabrutinib in the EU trials register (CTIS)
1 trial · 1 in IrelandAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Acalabrutinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
The MAVRiC Study: A Phase II Study of Disease Risk Mutation-guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab
2024-518858-17-00 · Neoplasms
|
Phase 2 | Ongoing | AstraZeneca AB | Ireland + 5 more |
Acalabrutinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Acalabrutinib on the HPRA medicines list.
- Calquence 100 mg hard capsulesAstraZeneca AB · EU/1/20/1479/001-002
- Calquence film-coated tabletsAstraZeneca AB · EU/1/20/1479/001-004
Supply shortages
No entry for Acalabrutinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Acalabrutinib
43 conditionsAll 43 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Lymphocytic Leukemia | 15 |
| Small Lymphocytic Lymphoma | 4 |
| Mantle Cell Lymphoma (MCL) | 4 |
| Mantle Cell Lymphoma | 3 |
| Chronic Lymphocytic Leukemia (CLL) | 2 |
| Diffuse Large B Cell Lymphoma | 2 |
| Non Hodgkin Lymphoma | 2 |
| Chronic Lymphocytic Leukaemia | 2 |
| Mantle-cell Lymphoma | 2 |
| Large B-cell Lymphoma | 2 |
| Diffuse Large B-Cell Lymphoma | 2 |
| Small Lymphocytic Lymphoma (SLL) | 1 |
| Chronic Lymphocytic Leukemia, CLL | 1 |
| Waldenström Macroglobulinemia (WM) | 1 |
| Moderate to Severe Cardiac Impairment | 1 |
| Richter's Syndrome | 1 |
| Prolymphocytic Leukemia | 1 |
| Lymphoma, Mantle-Cell | 1 |
| Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | 1 |
| Indolent B-Cell Non-Hodgkin Lymphoma | 1 |
| Glioblastoma Multiforme | 1 |
| Lymphoma, Mantle Cell | 1 |
| CLL/SLL | 1 |
| Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) | 1 |
| Untreated Chronic Lymphocytic Leukemia | 1 |
| Phase I: Relapsed or Refractory B-cell Malignancies | 1 |
| Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma | 1 |
| Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia | 1 |
| Hematologic Cancer | 1 |
| MACE | 1 |
| BTK Inhibitors | 1 |
| Diffuse Large B-cell Lymphoma | 1 |
| Marginal Zone Lymphoma | 1 |
| CLL | 1 |
| Waldenstrom Macroglobulinemia | 1 |
| Refractory Lymphoma | 1 |
| Refractory Aggressive B-cell Lymphomas | 1 |
| Refractory B-Cell Non-Hodgkin Lymphoma | 1 |
| Aggressive B-cell NHL | 1 |
| Diffuse Large B-cell Lymphoma (DLBCL) | 1 |
| Central Nervous System Lymphoma | 1 |
| Refractory Central Nervous System Lymphoma | 1 |
| Recurrent Central Nervous System Lymphoma | 1 |
Sponsors
lead sponsor per trial+ 9 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Acalabrutinib trials
How many clinical trials are testing Acalabrutinib?
49 current trials in our USA, Spain, Italy, UK, Poland, France, Australia, China, Israel, Czechia, Germany, Canada, Brazil, Taiwan, Belgium, South Korea, Netherlands, Sweden, Austria, Denmark, Japan, Turkey, Switzerland, Portugal, Mexico, Ireland, Singapore, Egypt, Norway and India registers name Acalabrutinib (also registered as ACP-196) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Acalabrutinib trials recruiting patients?
Yes. 19 of the 49 trials are recruiting: 9 with sites in USA, 8 with sites in Spain, 5 with sites in Italy, 8 with sites in UK, 6 with sites in Poland, 4 with sites in France, 5 with sites in Australia, 8 with sites in China, 2 with sites in Israel, 6 with sites in Czechia, 6 with sites in Germany, 2 with sites in Canada, 5 with sites in Brazil, 4 with sites in Taiwan, 2 with sites in Belgium, 4 with sites in South Korea, 2 with sites in Netherlands, 4 with sites in Sweden, 1 with sites in Austria, 3 with sites in Denmark, 2 with sites in Japan, 1 with sites in Turkey, 1 with sites in Switzerland, 2 with sites in Portugal, 1 with sites in Mexico, 1 with sites in Ireland and 1 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Acalabrutinib clinical trials?
Acerta Pharma BV (15), AstraZeneca (11), Dana-Farber Cancer Institute (2) and AbbVie (1), among 24 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Acalabrutinib clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov), and 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Acalabrutinib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Acalabrutinib, for example Calquence 100 mg hard capsules (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Acalabrutinib shortage?
Not in the lists we track: Acalabrutinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Acalabrutinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Acalabrutinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Acalabrutinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.