EMA · European Union
rimegepant — EMA regulatory status
rimegepant (VYDURA) 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
- VYDURA
- Mechanism
- Calcitonin gene-related peptide type 1 receptor antagonist
- Target
- Calcitonin gene-related peptide type 1 receptor
- Structured fields
- 6
Pharmacology context used for competitive intelligence: Calcitonin gene-related peptide type 1 receptor antagonist. Target: Calcitonin gene-related peptide type 1 receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 10 published clinical programs and 0 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 |
|---|---|---|---|
| C4951002 | Phase 3 | First Biotech (Australia) | 2024-512743-23-00 |
| C4951003 | Phase 3 | First Biotech (Australia) | 2024-512744-32-00 |
| C4951009 | Phase 3 | First Biotech (Australia) | 2024-512382-13-00 |
| C4951013 | Phase 3 | First Biotech (Australia) | 2023-505601-16-00 |
| C4951063 | Phase 3 | First Biotech (Australia) | 2024-517121-10-00 |
| Rimegepant | Phase 3 | Pfizer | NCT05156398 |
| C4951004/BHV3000-406 | Approved | First Biotech (Australia) | 2024-513269-37-00 |
| C4951012/BHV3000-407 | Approved | First Biotech (Australia) | 2024-513270-21-00 |
| MAMBO-II | Approved | George Institute for | 2024-519770-38-00 |
| RIMEGEPANT , Capsaicin | Approved | Disc Medicine | 2024-513359-34-00 |
Related hubs
FAQ
What is the EMA approval status of rimegepant?
rimegepant 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 rimegepant 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 rimegepant?
This spoke lists 10 published programs associated with rimegepant in our pipeline index.