EMA · European Union
acalabrutinib — EMA regulatory status
acalabrutinib (CALQUENCE) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- CALQUENCE
- Originator
- AstraZeneca
- Mechanism
- Tyrosine-protein kinase BTK inhibitor
- Target
- Tyrosine-protein kinase BTK
- Structured fields
- 8
Sponsor / originator context: AstraZeneca. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Tyrosine-protein kinase BTK inhibitor. Target: Tyrosine-protein kinase BTK. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 35 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| ACE-CL-006 | Phase 3 | Anaxis Pharma | 2023-509347-27-00 |
| ACE-CL-007 | Phase 3 | Anaxis Pharma | 2023-509348-84-00 |
| ACE-CL-311 (AMPLIFY) | Phase 3 | Anaxis Pharma | 2023-509349-11-00 |
| ACE-LY-308 | Phase 3 | Anaxis Pharma | 2023-509354-58-00 |
| APG2575CC301 | Phase 3 | Anaxis Pharma | 2024-514084-26-00 |
| APG2575CG301 | Phase 3 | Anaxis Pharma | 2023-508005-24-00 |
| Acalabrutinib | Phase 3 | AstraZeneca | NCT04075292 |
| BGB-11417-304 | Phase 3 | BEONE MEDICINES AUS | 2025-524366-21-00 |
| Calquence 100 mg hard capsules | Phase 3 | Anaxis Pharma | 2023-509359-15-00 |
| Calquence 100 mg hard capsules | Phase 3 | AstraZeneca | 2023-507669-24-00 |
| D8220C00027 | Phase 3 | AstraZeneca | 2023-505866-27-00 |
| D8227C00001 | Phase 3 | Anaxis Pharma | 2023-509358-72-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026093541 | SCHÉMAS POSOLOGIQUES POUR L'AZD5004 | WO |
| 2026093542 | TRAITEMENT D'ASSOCIATION D'UN AGONISTE DU GLP1R ET D'UN INHIBITEUR DU SGLT-2 | WO |
| 2026093537 | MÉTHODES DE TRAITEMENT DU DIABÈTE | WO |
| 2026093543 | TRAITEMENT COMBINÉ PAR AGONISTE DU GLP1R ET INHIBITEUR DE PCSK9 | WO |
| 2026094002 | COMBINAISONS DE MOLÉCULES D'ACTIVATION DE LYMPHOCYTES T BISPÉCIFIQUES DESTINÉES À ÊTRE UTILISÉES DANS LE TRAITEMENT DE TUMEURS SOLIDES EXPRIMANT CLAUDINE 18.2 | WO |
| 2026093539 | MÉTHODES DE TRAITEMENT OU DE GESTION DE L'OBÉSITÉ | WO |
| 2026078163 | CONJUGUÉS COMPRENANT DES LIANTS | WO |
| 2026078165 | CONJUGUÉS COMPRENANT DES LIANTS CLIVABLES | WO |
| 2026057582 | COMBINAISONS THÉRAPEUTIQUES D'UN INHIBITEUR D'AKT, D'UN INHIBITEUR DE BCL-2 ET D'UN GLUCOCORTICOÏDE | WO |
| 2026057740 | TRAITEMENT DU CANCER AVEC DES MOLÉCULES DE LIAISON THÉRAPEUTIQUES | WO |
| 2026017827 | COMPOSÉS DE CARBOXAMIDE UTILISÉS EN TANT QU'INHIBITEURS DE PKMYT1 | WO |
| 2025257199 | THÉRAPIES POUR LE TRAITEMENT DE PLAIES | WO |
Related hubs
FAQ
What is the EMA approval status of acalabrutinib?
acalabrutinib currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get acalabrutinib regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to acalabrutinib?
This spoke lists 35 published programs associated with acalabrutinib in our pipeline index.