Product Description
Rimegepant (ri me' je pant) is an orally available, small molecule inhibitor of the receptor for the calcitonin gene-related peptide (CGRP), which is believed to play a role in the pathogenesis of migraine headaches. CGRP is a potent vasodilator and pain-signaling neurotransmitter that is found throughout the central and peripheral nervous system but is particularly common in trigeminal ganglia. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK572432/)
Mechanisms of Action: CGRP Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Austria | Belgium | Chile | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Lithuania | Luxembourg | Mexico | Norway | Philippines | Poland | Portugal | Romania | Slovakia | Spain | Sweden | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, China, Czech Republic, Denmark, Finland, France, Hungary, India, Italy, Japan, Mexico, Poland, Slovakia, Spain, Sweden, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 26
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Migraine Disorders|Migraine with Aura|Migraine without Aura|Nasal Polyposis|Sinusitis
Phase 2: Irritable Bowel Syndrome|Psoriasis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NCT06221111 | P2 |
Completed |
Irritable Bowel Syndrome |
2025-05-30 |
12% |
2025-06-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
| NCT04629950 | P2 |
Completed |
Psoriasis |
2024-08-20 |
50% |
2025-07-18 |
Primary Endpoints|Treatments |
| C4951003-BHV3000-312 | P3 |
Recruiting |
Migraine without Aura|Migraine with Aura|Migraine Disorders |
2025-09-01 |
64% |
2025-05-02 |
Treatments |
| C4951019 | P3 |
Active, not recruiting |
Migraine Disorders |
2025-08-25 |
27% |
2025-09-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments |
| BHV3000-316 | P3 |
Completed |
Nasal Polyposis|Sinusitis |
2024-03-11 |
20% |
2024-06-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| BHV3000-312 | P3 |
Recruiting |
Migraine Disorders |
2030-07-31 |
64% |
2025-05-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| Acute Treatment | P3 |
Recruiting |
Migraine Disorders |
2029-01-09 |
65% |
2024-11-14 |
Primary Endpoints |
| jRCT2051240163 | P3 |
Not yet recruiting |
Migraine Disorders |
2028-07-11 |
|||
| C4951013 | P3 |
Not yet recruiting |
Migraine Disorders |
2027-12-02 |
2025-05-02 |
Treatments |
|
| C4951009 | P3 |
Recruiting |
Migraine Disorders|Migraine without Aura|Migraine with Aura |
2027-06-09 |
2025-05-02 |
Treatments |
|
| jRCT2031250041 | P3 |
Not yet recruiting |
Migraine Disorders |
2027-04-30 |
|||
| BHV3000-315 | P3 |
Recruiting |
Migraine Disorders |
2027-04-29 |
64% |
2025-03-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| jRCT2031240036 | P3 |
Recruiting |
Migraine Disorders |
2027-04-29 |
|||
| C4951063 | P3 |
Not yet recruiting |
Migraine Disorders |
2027-03-30 |
|||
| jRCT2031230579 | P3 |
Not yet recruiting |
Migraine Disorders |
2027-01-31 |
|||
| C4951063 | P3 |
Recruiting |
Migraine Disorders |
2026-11-29 |
27% |
2025-03-28 |
Primary Endpoints |
| C4951013 | P3 |
Recruiting |
Migraine Disorders |
2026-10-08 |
25% |
2025-06-07 |
Primary Endpoints |
| jRCT2031220237 | P3 |
Recruiting |
Migraine Disorders |
2025-03-31 |
|||
| C4951002 | P3 |
Recruiting |
Migraine without Aura|Migraine with Aura|Migraine Disorders |
2025-02-15 |
65% |
2025-05-02 |
Treatments |
| 2020-003761-18 | P3 |
Active, not recruiting |
Migraine without Aura|Migraine with Aura|Migraine Disorders |
2024-09-13 |
2022-03-13 |
Treatments |
|
| jRCT2031220236 | P3 |
Recruiting |
Migraine Disorders |
2024-06-30 |
|||
| CTR20220692 | P3 |
Completed |
Migraine Disorders |
2024-02-06 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
| BHV3000-318 | P3 |
Completed |
Migraine Disorders |
2024-02-06 |
38% |
2024-04-27 |
Primary Endpoints|Study Completion Date|Treatments |
| Japan Only | P3 |
Completed |
Migraine Disorders |
2024-01-19 |
27% |
2025-02-12 |
Patient Enrollment|Primary Endpoints|Treatments |
| Japan Only | P3 |
Completed |
Migraine Disorders |
2024-01-18 |
38% |
2025-07-15 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
06/19/2025 |
News Article |
Lundbeck Advances Leadership in Migraine With New Data at the American Headache Society 67th Annual Scientific Meeting |
|
05/16/2024 |
News Article |
Pharmaceutical Contract Packaging Market Size Expected to Reach USD 36.11 Bn by 2032 |
|
04/04/2024 |
News Article |
NURTEC ODT® is Now Available in Canada for the Treatment of Acute Migraine |
|
03/11/2024 |
News Article |
American Headache Society Publishes Updated Guidance on Migraine Preventive Therapy |