FDA · United States
rimegepant — FDA regulatory status
rimegepant (VYDURA) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA 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 — FDA: 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 |
|---|---|---|---|---|
| FDA | United States | 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 FDA approval status of rimegepant?
rimegepant currently shows FDA approved in our United States regulatory index. Confirm on the official FDA 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.