EMA · European Union
azacitidine — EMA regulatory status
azacitidine (AZACITIDINE ACCORD) 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
- AZACITIDINE ACCORD
- Originator
- Lacuna Pharma Pty Ltd
- Mechanism
- DNA (cytosine-5)-methyltransferase 3A inhibitor
- Target
- DNA (cytosine-5)-methyltransferase 1
- Structured fields
- 8
Sponsor / originator context: Lacuna Pharma Pty 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: DNA (cytosine-5)-methyltransferase 3A inhibitor. Target: DNA (cytosine-5)-methyltransferase 1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 58 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 |
|---|---|---|---|
| 09 | Phase 3 | First People's Hospital | NCT06345365 |
| 2215-CL-0201 | Phase 3 | Astellas Pharma | 2024-512474-98-00 |
| 75276617AML3001 | Phase 3 | Janssen-Cilag International N.V | 2024-520154-38-00 |
| AG120-C-009 | Phase 3 | George Institute for | 2024-514309-73-00 |
| APG2575AG301 | Phase 3 | Anaxis Pharma | 2024-516436-10-00 |
| APG2575MG301 | Phase 3 | Anaxis Pharma | 2024-517247-31-00 |
| APR-246 + azacitidine | Phase 3 | Aprea Therapeutics | NCT03745716 |
| ASTX030-01 | Phase 3 | Taiho Pharma Canada | 2024-515098-93-00 |
| Azacitidine | Phase 3 | Takeda | NCT03268954 |
| Azacitidine Combined With Venetoclax and ATRA group | Phase 3 | First People's Hospital | NCT05654194 |
| CSET 2025/4132 | Phase 3 | George Institute for | 2025-521634-29-00 |
| IRST204.07 | Phase 3 | Istituto Gentili Italia | 2024-514517-35-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12428406 | Methods and compounds for restoring mutant p53 function | US |
| 12419880 | Companion diagnostic tool for mutant p53 reactivating compounds | US |
| 2025027051 | INHIBITEURS DE SPHINGOSINE-1-PHOSPHATE LYASE DESTINÉS À ÊTRE UTILISÉS DANS LE TRAITEMENT DE MALADIES NEURODÉGÉNÉRATIVES | WO |
| 2024211523 | SCHÉMAS POSOLOGIQUES DESTINÉS À ÊTRE UTILISÉS DANS LA PRÉVENTION DE LA RECHUTE DE LA LEUCÉMIE MYÉLOÏDE AIGUË APRÈS UNE TRANSPLANTATION DE CELLULES SOUCHES HÉMATOPOÏÉTIQUES ALLOGÉNIQUES AVEC DU VÉNÉTOCLAX EN COMBINAISON AVEC DE L'AZACITIDINE | WO |
| 2024175803 | COMPOSÉS POUR LE TRAITEMENT DE MALADIES MYÉLOÏDES AVEC DES ANOMALIES CHROMOSOMIQUES | WO |
| 2024146923 | INHIBITEURS DE POLYMÉRISATION DE TUBULINE | WO |
| 11963953 | Deuterated compounds for restoring mutant p53 function | US |
| 11926632 | Methods and compounds for restoring mutant p53 function | US |
| 11814373 | Methods and compounds for restoring mutant p53 function | US |
| 11807644 | Methods and compounds for restoring mutant p53 function | US |
| 11731953 | Methods and compounds for restoring mutant p53 function | US |
| 2022234069 | NOUVEAUX DÉRIVÉS DE 2-AMINOOXAZOLE ET LEUR UTILISATION POUR LE TRAITEMENT DE MALADIES INFECTIEUSES | WO |
Related hubs
FAQ
What is the EMA approval status of azacitidine?
azacitidine 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 azacitidine 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 azacitidine?
This spoke lists 58 published programs associated with azacitidine in our pipeline index.