EMA · European Union
abiraterone acetate — EMA regulatory status
abiraterone acetate (ABIRATERONE KRKA) 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
- ABIRATERONE KRKA
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Cytochrome P450 17A1 inhibitor
- Target
- Steroid 17-alpha-hydroxylase/17,20 lyase
- Structured fields
- 8
Sponsor / originator context: Amneal Pharma Europe Ltd. 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: Cytochrome P450 17A1 inhibitor. Target: Steroid 17-alpha-hydroxylase/17,20 lyase. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 23 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 |
|---|---|---|---|
| 20230005 | Phase 3 | Amgen | 2024-513968-25-00 |
| 20230239 | Phase 3 | Amgen | 2025-520555-89-00 |
| 56021927PCR3001 | Phase 3 | Janssen-Cilag International N.V | 2023-508606-26-00 |
| 64091742PCR3001 | Phase 3 | Janssen-Cilag International N.V | 2023-503254-12-00 |
| 67652000PCR3002 | Phase 3 | Janssen-Cilag International N.V | 2023-506365-64-00 |
| ARN-509-003 | Phase 3 | Anaxis Pharma | 2023-509221-47-00 |
| CAAA617B12302 | Phase 3 | Novartis India | 2023-507772-50-00 |
| D361BC00001 | Phase 3 | AstraZeneca | 2023-504998-20-00 |
| D9727C00001 | Phase 3 | AstraZeneca | 2024-513586-39-00 |
| MK-5684-003 | Phase 3 | MSD Merck Sharp | 2023-504899-25-00 |
| MK-5684-004 | Phase 3 | MSD Merck Sharp | 2023-504957-11-00 |
| Niraparib tosylate monohydrate + abiraterone... for Prostate Cancer | Phase 3 | George Institute for | 2023-506857-40-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026112486 | MÉTHODES DE TRAITEMENT DE L'OBÉSITÉ ET DES AFFECTIONS LIÉES À L'OBÉSITÉ | WO |
| 2026102199 | THÉRAPIE COMBINÉE D'UN INHIBITEUR DE PRMT5 ET DU DARAXONRASIB POUR UTILISATION DANS LE TRAITEMENT DU CANCER MTAP-NUL | WO |
| 2026072909 | PROTÉINES DE LIAISON À FLT1 ET MÉTHODES D'UTILISATION | WO |
| 2026055477 | COMPOSÉS MACROCYCLIQUES CONSTITUANT DES MODULATEURS DE KRAS ET LEURS UTILISATIONS | WO |
| 2026039321 | MÉTHODES DE TRAITEMENT DU CANCER DE LA PROSTATE | WO |
| 2026020076 | MÉTHODE DE TRAITEMENT DU PRURIGO NODULAIRE | WO |
| 2026006398 | RÉDUCTASES D'IMINE MODIFIÉES ET LEURS PROCÉDÉS D'UTILISATION | WO |
| 2026006803 | COMPOSÉS À NOYAU À 5 CHAÎNONS UTILISÉS EN TANT QUE MODULATEURS DE L'HÉLICASE D'ADN RECQ DU SYNDROME DE WERNER ET LEURS UTILISATIONS | WO |
| 2026006805 | COMPOSÉS À NOYAU À 6 CHAÎNONS UTILISÉS COMME MODULATEURS DE L'HÉLICASE À ADN RECQ DU SYNDROME DE WERNER ET LEURS UTILISATIONS | WO |
| 2025265110 | COMPOSITIONS PHARMACEUTIQUES ORALES RENFERMANT UN COMPOSÉ DE NAPHTYRIDINE | WO |
| 2025259515 | POLYTHÉRAPIE | WO |
| 2025260042 | CONSTRUCTIONS D'ARNI ET PROCÉDÉS D'INHIBITION DE L'EXPRESSION DE CNR1 | WO |
Related hubs
FAQ
What is the EMA approval status of abiraterone acetate?
abiraterone acetate 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 abiraterone acetate 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 abiraterone acetate?
This spoke lists 23 published programs associated with abiraterone acetate in our pipeline index.