Data updated: Jun 28, 2026
RIMEGEPANT
Trial Activity: Stable 8 active trials
CNS
Development Insights
Pfizer conducting 19 trials (70%)
16 indications explored (Broad Platform)
→ migraine (12 trials)
→ migraine, with or without aura (4 trials)
→ menstrual migraine (2 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
RIMEGEPANT Approval History
No approval records found
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Clinical Trial Registry
28 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05156398 | BHV3000-315 C4951009, 2021-005246-15 | Ph 3 | recruiting | Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects |
| NCT06641466 | C4951063 NCT06641466 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine |
| NCT06616194 | C4951013 BHV3000-320, 2023-505601-16-00 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine |
| NCT06985342 | STUDY-24-01677 | Ph 4 | terminated | Acute Migraine Treatment in the ED With Gepants |
| NCT05509400 results posted | BHV3000-406 C4951004, 2022-001175-14 | Ph 4 | completed | Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use |
| NCT05810038 | C4951019 BHV3000-319 | Ph 3 | completed | A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects. |
| NCT05264714 | 21-003394 | Ph 2 | completed | Cluster Headache Treatment With Rimegepant |
| NCT05399485 results posted | BHV3000-309 C4951021 | Ph 3 | completed | Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only) |
| NCT06473597 | 2023-12-20 | Ph 4 | recruiting | A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache |
| NCT05207865 results posted | BHV3000-405 C4951011 | Ph 4 | completed | Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention |
| NCT05518123 results posted | BHV3000-407 C4951012, 2024-513270-21-00 | Ph 4 | completed | Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications |
| NCT04629950 results posted | 20-07022368 | Ph 2 | completed | Rimegepant in Moderate Plaque-type Psoriasis |
| NCT06992674 | 2025-0124 | Ph 2 | active not recruiting | The R-E-V-I-V-A-L Study |
| NCT06999252 | Passion CRC | Ph 2 | not yet recruiting | Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients |
| NCT06748664 | 2024-0366 | Ph 2 | not yet recruiting | A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment |
| NCT05127486 CHALLENGE-MIG results posted | 18256 I5Q-MC-CGBD | Ph 4 | completed | A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine |
| NCT03941834 results posted | BHV3000-202 C4951014 | Ph 2 | terminated | Trial for Treatment Refractory Trigeminal Neuralgia |
| NCT03732638 results posted | BHV3000-305 | Ph 2, Ph 3 | completed | Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults |
| NCT05262517 results posted | BHV3000-317 C4951016 | Ph 3 | terminated | Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders |
| NCT04574362 results posted | BHV3000-310 C4951026 | Ph 3 | completed | Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine |
| NCT01430442 results posted | CN170-003 | Ph 2 | completed | Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine |
| NCT03235479 results posted | BHV-3000-301 | Ph 3 | completed | Safety and Efficacy Study in Adult Subjects With Acute Migraines |
| NCT03461757 results posted | BHV3000-303 | Ph 3 | completed | Trial in Adult Subjects With Acute Migraines |
| NCT03237845 results posted | BHV3000-302 | Ph 3 | completed | Safety and Efficacy in Adult Subjects With Acute Migraines |
| NCT03266588 results posted | BHV3000-201 | Ph 2, Ph 3 | completed | Open Label Safety Study in Acute Treatment of Migraine |
| NCT07613788 | RIME-CART | Ph 2 | not yet recruiting | Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL |
| NCT07609914 | C4951086 | Ph 4 | recruiting | A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine |
| NCT07667621 | STUDY009783 | Ph 1 | not yet recruiting | A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RIMEGEPANT FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment