EMA · European Union
abemaciclib — EMA regulatory status
abemaciclib (VERZENIO) 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
- VERZENIO
- Mechanism
- Cyclin-dependent kinase 6 inhibitor
- Target
- Cyclin-dependent kinase 4
- Structured fields
- 7
Pharmacology context used for competitive intelligence: Cyclin-dependent kinase 6 inhibitor. Target: Cyclin-dependent kinase 4. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 43 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 |
|---|---|---|---|
| ABEMACICLIB , FULVESTRANT | Phase 3 | Eli Lilly and | 2023-506781-30-00 |
| Abemaciclib | Phase 3 | Eli Lilly and | NCT02246621 |
| Abemaciclib | Phase 3 | Eli Lilly and | NCT02152631 |
| Abemaciclib | Phase 3 | United Therapeutics Europe | NCT04584853 |
| Bemnifosbuvir (BEM) | Phase 3 | Atea Pharmaceuticals | NCT05629962 |
| C4391024 | Phase 3 | First Biotech (Australia) | 2024-512925-95-00 |
| CO44657 | Phase 3 | HOFFMANN-LA ROCHE | 2022-502980-39-00 |
| D8534C00001 | Phase 3 | AstraZeneca | 2023-503990-39-00 |
| D8535C00001 | Phase 3 | AstraZeneca | 2023-504031-41-00 |
| D9722C00001 | Phase 3 | AstraZeneca | 2023-504180-16-00 |
| I3Y-MC-JPCF | Phase 3 | Eli Lilly and | 2023-509671-17-00 |
| I3Y-MC-JPCM | Phase 3 | Eli Lilly and | 2023-506777-36-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025233501 | CONJUGUÉS COMPRENANT UN INHIBITEUR DE TOPOISOMÉRASE I | WO |
| 12427137 | Method for reducing methane production in animal stomach | US |
| 12389931 | Oyster peptide with effect of improving sexual function and preparation method thereof | US |
| 12331040 | Substituted benzofuranyl and benzoxazolyl compounds and uses thereof | US |
| 12324798 | Leonurine nanocomposite hydrogel and preparation methods and applications thereof | US |
| 12297300 | Hyaluronic acid-based zwitterionic polymer brush, preparation method thereof, and use thereof | US |
| 12291530 | GLP-1R agonist and therapeutic method thereof | US |
| 12269808 | Amino dithioperacid thioester compound, preparation method therefor, and use thereof | US |
| 12234236 | GLP-1R agonist and therapeutic method thereof | US |
| 12226476 | Helper epitope peptide and application thereof | US |
| 12221414 | Quaternary ammonium salt compound, preparation method therefor and use thereof | US |
| 12144881 | Cosmetic composition containing α-mangostin, method for preparation, and uses thereof | US |
Related hubs
FAQ
What is the EMA approval status of abemaciclib?
abemaciclib 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 abemaciclib 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 abemaciclib?
This spoke lists 43 published programs associated with abemaciclib in our pipeline index.