Calquence
An oral targeted therapy used to treat chronic lymphocytic leukemia and mantle cell lymphoma.
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 5 Oct 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), 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.
What Calquence is used for
CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). (1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). 1.2 Previously Treated Mantle Cell Lymphoma CALQUENCE is indicated for the treatment of adult patients with MCL who ha…
How it works
12.1 Mechanism of Action Acalabrutinib is a small-molecule inhibitor of Bruton tyrosine kinase (BTK). Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK‑mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenogr…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 5 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.