Rimegepant History and Updates

192 events · 2011 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 16, 2026.

FDA Approvals

Label Revisions

178

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Rimegepant since 2011, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (17)

2026

Label revisionNurtec ODT Label Revised for Acute and Preventive Migraine Treatment· Jun 4, 2026
Results postedRimegepant for IBS: No Abdominal Pain Improvement, Some Rectal Sensation…· May 22, 2026
Results postedRimegepant Reduces Migraine Days in Patients with Inadequate Oral Preventive…· May 22, 2026
Results postedRimegepant Demonstrates Pain Relief and Freedom in Triptan-Unsuitable Migraine· Apr 21, 2026
Results postedRimegepant vs. Triptans: Migraine Treatment Usage Compared in US Survey· Jan 22, 2026

2025

Results postedRimegepant Reduces Migraine Days in Episodic Migraine Prevention Trial· Dec 16, 2025
Results postedRimegepant Daily Dosing for Episodic Migraine Prevention Shows Favorable…· Sep 3, 2025
Primary completionRimegepant Phase 3 Trial for Migraine Prevention in Chinese Subjects Completes· Aug 25, 2025
Results postedRimegepant Phase 2 Trial for Psoriasis Shows No Improvement Over Placebo· Jul 17, 2025
Results postedRimegepant Shows Significant Migraine Day Reduction in Japanese Phase 3 Trial· Jul 14, 2025
Results postedRimegepant Phase 3 Trial for Chronic Rhinosinusitis Shows No Significant Benefit· Mar 26, 2025
Results postedRimegepant: Long-Term Safety Data for Acute Migraine in Chinese Participants· Feb 20, 2025
Results postedRimegepant 75 mg Improves Acute Migraine Pain Freedom in Japanese Trial· Feb 10, 2025

2022

FDA approval (supplemental)Nurtec ODT (rimegepant) FDA Approves Supplemental Efficacy Application· Apr 11, 2022

2021

FDA approval (supplemental)Nurtec ODT (rimegepant) Receives FDA Supplemental Approval for Efficacy· May 27, 2021
Pivotal publicationRimegepant Phase 2/3 Trial for Migraine Prevention Published in Lancet· Jan 1, 2021

2020

FDA approvalNurtec ODT (Rimegepant) Receives Initial FDA Approval as New Molecular Entity· Feb 27, 2020

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Primary completion: NCT06728345

The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China

Primary completionJul 31, 2026· ClinicalTrials.gov

Primary completion: NCT06898047

Consistency of Response With Rimegepant in Acute Treatment of Migraine

Primary completionSep 1, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06748664

A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT07301008

Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US

Trial startedOct 1, 2026· ClinicalTrials.gov

Trial started: NCT07497854

A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea

Primary completionOct 8, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06616194

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Primary completionNov 29, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06641466

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06473597

A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache

Primary completionJan 1, 2027· ClinicalTrials.gov

Primary completion: NCT06409832

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT07435090

Efficacy and Safety of Rimegepant for Acute Dizziness

Primary completionApr 17, 2028· ClinicalTrials.gov

Primary completion: NCT05198245

Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Primary completionMay 14, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT07609914

A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine

Primary completionMay 15, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT07609914

A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine

Primary completionNov 30, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07613788

Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL

Primary completionDec 1, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06999252

Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07475234

Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma

Primary completionJan 9, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT04649242

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Primary completionJul 31, 2030· ClinicalTrials.gov

Primary completion: NCT07497854

A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea

Primary completionJul 31, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT04743141

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Primary completionNov 29, 2031· ClinicalTrials.gov

Phase 3 primary completion: NCT05156398

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

Past events

2026

Label revisionJun 4, 2026· FDA

Indication and usage updated on NURTEC ODT label (effective 2026-06-04)

1 INDICATIONS AND USAGE NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: • acute treatment of migraine with or without aura in adults ( 1.1 ) • preventive treatment of episodic migraine in adults ( 1.2

Primary completionJun 1, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06992674

The R-E-V-I-V-A-L Study

Primary completionMay 31, 2026· ClinicalTrials.gov

Primary completion: NCT06212661

Migraine Medication Effects on Urinary Symptoms

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07613788

Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL

Trial registeredMay 29, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07613788

Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL

Trial registeredMay 27, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07609914

A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine

Trial startedMay 27, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07609914

A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine

Results postedMay 22, 2026· ClinicalTrials.gov

Trial results posted: NCT06221111

Comparison of Rimegepant and Placebo for Pain in IBS

Results postedMay 22, 2026· ClinicalTrials.gov

Trial results posted: NCT05518123

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medi

FDA approval (supplemental)May 8, 2026· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Labeling (NDA 212728 S-32)

Sponsor: PFIZER. Class: Labeling.

Results postedApr 21, 2026· ClinicalTrials.gov

Trial results posted: NCT05509400

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Trial startedMar 31, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07475234

Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma

Trial registeredMar 27, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07497854

A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea

Trial startedMar 20, 2026· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT07435090

Efficacy and Safety of Rimegepant for Acute Dizziness

Trial registeredMar 16, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07475234

Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma

FDA approval (supplemental)Mar 16, 2026· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Labeling (NDA 212728 S-29)

Sponsor: PFIZER. Class: Labeling.

Trial registeredFeb 27, 2026· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT07435090

Efficacy and Safety of Rimegepant for Acute Dizziness

Results postedJan 22, 2026· ClinicalTrials.gov

Trial results posted: NCT06680206

Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey

Primary completionJan 6, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06985342

Acute Migraine Treatment in the ED With Gepants

2025

Primary completionDec 31, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05264714

Cluster Headache Treatment With Rimegepant

Trial registeredDec 24, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07301008

Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US

Results postedDec 16, 2025· ClinicalTrials.gov

Trial results posted: NCT05217927

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Trial startedNov 15, 2025· ClinicalTrials.gov

Trial started: NCT06898047

Consistency of Response With Rimegepant in Acute Treatment of Migraine

Primary completionSep 28, 2025· ClinicalTrials.gov

Primary completion: NCT06439628

ARISE-A Chinese Real-world Study of Rimegepant for the Acute Treatment of Migraine

Trial startedSep 9, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT07301008

Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US

Results postedSep 3, 2025· ClinicalTrials.gov

Trial results posted: NCT05207865

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Primary completionAug 25, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05810038

A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.

FDA approval (supplemental)Aug 1, 2025· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Labeling (NDA 212728 S-28)

Sponsor: PFIZER. Class: Labeling.

Results postedJul 17, 2025· ClinicalTrials.gov

Trial results posted: NCT04629950

Rimegepant in Moderate Plaque-type Psoriasis

Results postedJul 14, 2025· ClinicalTrials.gov

Trial results posted: NCT05399485

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

Trial startedJul 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06999252

Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients

Trial startedJun 5, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT06985342

Acute Migraine Treatment in the ED With Gepants

Trial startedJun 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06748664

A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment

Trial startedJun 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06992674

The R-E-V-I-V-A-L Study

Trial registeredMay 31, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06999252

Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients

Primary completionMay 30, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06221111

Comparison of Rimegepant and Placebo for Pain in IBS

Trial registeredMay 28, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06992674

The R-E-V-I-V-A-L Study

Trial registeredMay 22, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06985342

Acute Migraine Treatment in the ED With Gepants

Primary completionApr 30, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT05211154

Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine

Primary completionMar 31, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT05518123

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medi

Trial registeredMar 27, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06898047

Consistency of Response With Rimegepant in Acute Treatment of Migraine

Results postedMar 26, 2025· ClinicalTrials.gov

Trial results posted: NCT05248997

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

FDA approval (supplemental)Mar 21, 2025· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Labeling (NDA 212728 S-26)

Sponsor: PFIZER. Class: Labeling.

Trial startedMar 11, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06641466

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Primary completionMar 10, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT05509400

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Results postedFeb 20, 2025· ClinicalTrials.gov

Trial results posted: NCT05371652

A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

Results postedFeb 10, 2025· ClinicalTrials.gov

Trial results posted: NCT05399459

Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

2024

Trial registeredDec 27, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06748664

A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment

FDA approval (supplemental)Dec 12, 2024· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Labeling (NDA 212728 S-25)

Sponsor: PFIZER. Class: Labeling.

Trial registeredDec 11, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06728345

The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China

Trial startedDec 1, 2024· ClinicalTrials.gov

Trial started: NCT06728345

The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China

Primary completionNov 20, 2024· ClinicalTrials.gov

Primary completion: NCT06680206

Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey

Trial startedNov 15, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06616194

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Trial registeredNov 8, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06680206

Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey

Primary completionOct 22, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05217927

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Trial registeredOct 15, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06641466

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Trial startedOct 10, 2024· ClinicalTrials.gov

Trial started: NCT06680206

Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey

Primary completionOct 6, 2024· ClinicalTrials.gov

Primary completion: NCT05709106

A Prospective Real World Study of Rimegepant in the Treatment of Migraine

Trial registeredSep 27, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06616194

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Trial startedSep 1, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06473597

A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache

Trial startedAug 27, 2024· ClinicalTrials.gov

Trial started: NCT06439628

ARISE-A Chinese Real-world Study of Rimegepant for the Acute Treatment of Migraine

Primary completionAug 20, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT04629950

Rimegepant in Moderate Plaque-type Psoriasis

Primary completionJul 30, 2024· ClinicalTrials.gov

Primary completion: NCT05888766

Predict the Response to Acute Treatment of Migraine With Rimegepant 75 mg

Primary completionJul 2, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05207865

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Primary completionJun 30, 2024· ClinicalTrials.gov

Primary completion: NCT06221267

A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

Trial registeredJun 25, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06473597

A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache

Results postedJun 18, 2024· ClinicalTrials.gov

Trial results posted: NCT05127486

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

Primary completionJun 15, 2024· ClinicalTrials.gov

Primary completion: NCT05903027

Gepant treAtments: EffectIveNess and tolERability (GAINER)

Results postedJun 10, 2024· ClinicalTrials.gov

Trial results posted: NCT03941834

Trial for Treatment Refractory Trigeminal Neuralgia

Trial startedJun 6, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06221111

Comparison of Rimegepant and Placebo for Pain in IBS

Trial registeredJun 3, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06439628

ARISE-A Chinese Real-world Study of Rimegepant for the Acute Treatment of Migraine

Primary completionMay 31, 2024· ClinicalTrials.gov

Primary completion: NCT06221267

A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

Results postedMay 16, 2024· ClinicalTrials.gov

Trial results posted: NCT05262517

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders

Trial registeredMay 10, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06409832

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment

Trial startedApr 5, 2024· ClinicalTrials.gov

Trial started: NCT06212661

Migraine Medication Effects on Urinary Symptoms

Trial startedMar 26, 2024· ClinicalTrials.gov

Trial started: NCT06409832

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment

Primary completionMar 11, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05248997

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Primary completionFeb 6, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05371652

A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

Results postedJan 31, 2024· ClinicalTrials.gov

Trial results posted: NCT04860713

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

Trial startedJan 26, 2024· ClinicalTrials.gov

Trial started: NCT06221267

A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

Trial registeredJan 24, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06221111

Comparison of Rimegepant and Placebo for Pain in IBS

Trial registeredJan 24, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06221267

A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

Primary completionJan 19, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05399459

Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Trial registeredJan 19, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06212661

Migraine Medication Effects on Urinary Symptoms

Primary completionJan 18, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05399485

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

2023

Results postedDec 14, 2023· ClinicalTrials.gov

Trial results posted: NCT04574362

Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

Trial startedJul 1, 2023· ClinicalTrials.gov

Trial started: NCT05888766

Predict the Response to Acute Treatment of Migraine With Rimegepant 75 mg

Trial registeredJun 15, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05903027

Gepant treAtments: EffectIveNess and tolERability (GAINER)

Trial startedJun 15, 2023· ClinicalTrials.gov

Trial started: NCT05903027

Gepant treAtments: EffectIveNess and tolERability (GAINER)

Trial registeredJun 5, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05888766

Predict the Response to Acute Treatment of Migraine With Rimegepant 75 mg

Primary completionMay 23, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT05127486

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

Primary completionMay 18, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05262517

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders

Trial startedMay 15, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05810038

A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.

Primary completionMay 11, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT03941834

Trial for Treatment Refractory Trigeminal Neuralgia

Trial registeredApr 12, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05810038

A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.

Trial registeredFeb 1, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05709106

A Prospective Real World Study of Rimegepant in the Treatment of Migraine

Trial startedJan 11, 2023· ClinicalTrials.gov

Trial started: NCT05709106

A Prospective Real World Study of Rimegepant in the Treatment of Migraine

2022

Trial startedNov 7, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05518123

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medi

Trial startedOct 18, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05509400

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Primary completionSep 30, 2022· ClinicalTrials.gov

Phase 4 primary completion: NCT04860713

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

Trial startedSep 7, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05264714

Cluster Headache Treatment With Rimegepant

Trial registeredAug 26, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05518123

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medi

Trial registeredAug 22, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05509400

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Trial startedAug 9, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05399485

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

Trial startedAug 9, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05399459

Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Trial registeredJun 1, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05399459

Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Trial registeredJun 1, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05399485

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

Trial startedMay 19, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05371652

A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

Trial registeredMay 12, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05371652

A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

Trial startedMay 5, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05262517

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders

Trial startedMay 5, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05211154

Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine

FDA approval (supplemental)Apr 11, 2022· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Efficacy (NDA 212728 S-9)

Sponsor: PFIZER. Class: Efficacy.

FDA approval (supplemental)Mar 31, 2022· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Manufacturing (CMC) (NDA 212728 S-14)

Sponsor: PFIZER. Class: Manufacturing (CMC).

Trial startedMar 15, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05207865

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Trial startedMar 4, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05217927

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Trial registeredMar 3, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05264714

Cluster Headache Treatment With Rimegepant

Trial registeredMar 2, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05262517

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders

Trial startedFeb 28, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05156398

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

Trial registeredFeb 21, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05248997

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Trial startedFeb 17, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05248997

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Trial registeredFeb 1, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05217927

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Trial registeredJan 27, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05211154

Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine

Trial registeredJan 26, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05207865

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Trial registeredJan 20, 2022· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05198245

Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

2021

Trial startedDec 15, 2021· ClinicalTrials.gov

Trial started: NCT05198245

Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Trial registeredDec 14, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05156398

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

FDA approval (supplemental)Dec 8, 2021· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Labeling (NDA 212728 S-12)

Sponsor: PFIZER. Class: Labeling.

Trial startedDec 6, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT05127486

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

Primary completionNov 24, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT04574362

Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

Trial registeredNov 19, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05127486

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

Results postedAug 9, 2021· ClinicalTrials.gov

Trial results posted: NCT03732638

Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

FDA approval (supplemental)May 27, 2021· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Efficacy (NDA 212728 S-6)

Sponsor: PFIZER. Class: Efficacy.

Trial startedApr 28, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04743141

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Trial registeredApr 27, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04860713

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

Trial startedApr 22, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT04860713

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

RecallMar 15, 2021· FDA

NURTEC ODT recall — Class II: CGMP Deviations: Intermittent exposure to temperature excursion during storage.

NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)

Trial registeredFeb 8, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04743141

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Trial startedJan 19, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04629950

Rimegepant in Moderate Plaque-type Psoriasis

Trial startedJan 15, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04649242

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Pivotal publicationJan 1, 2021· PubMed

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. (Lancet)

Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

2020

Results postedDec 23, 2020· ClinicalTrials.gov

Trial results posted: NCT03235479

Safety and Efficacy Study in Adult Subjects With Acute Migraines

Results postedDec 23, 2020· ClinicalTrials.gov

Trial results posted: NCT03237845

Safety and Efficacy in Adult Subjects With Acute Migraines

Trial registeredDec 2, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04649242

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Trial registeredNov 16, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04629950

Rimegepant in Moderate Plaque-type Psoriasis

Trial startedOct 22, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04574362

Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

Trial registeredOct 5, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04574362

Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

Results postedSep 3, 2020· ClinicalTrials.gov

Trial results posted: NCT01430442

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

FDA approval (supplemental)Aug 18, 2020· FDA

FDA approved supplemental application for Nurtec Odt (rimegepant sulfate) — Labeling (NDA 212728 S-1)

Sponsor: PFIZER. Class: Labeling.

Results postedJul 2, 2020· ClinicalTrials.gov

Trial results posted: NCT03266588

Open Label Safety Study in Acute Treatment of Migraine

Results postedMar 27, 2020· ClinicalTrials.gov

Trial results posted: NCT03461757

Trial in Adult Subjects With Acute Migraines

FDA approvalFeb 27, 2020· FDA

FDA approved Nurtec Odt (rimegepant sulfate) (NDA 212728)

Sponsor: PFIZER. Class: Type 1 - New Molecular Entity.

2019

Primary completionDec 10, 2019· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT03732638

Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

Primary completionJul 15, 2019· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT03266588

Open Label Safety Study in Acute Treatment of Migraine

Trial startedJun 25, 2019· ClinicalTrials.gov

Phase 2 trial started: NCT03941834

Trial for Treatment Refractory Trigeminal Neuralgia

Trial registeredMay 8, 2019· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03941834

Trial for Treatment Refractory Trigeminal Neuralgia

Trial registeredMay 1, 2019· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT03934086

An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

2018

Trial startedNov 14, 2018· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT03732638

Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

Trial registeredNov 6, 2018· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT03732638

Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

Primary completionOct 8, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT03461757

Trial in Adult Subjects With Acute Migraines

Trial registeredMar 12, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03461757

Trial in Adult Subjects With Acute Migraines

Trial startedFeb 27, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03461757

Trial in Adult Subjects With Acute Migraines

Primary completionJan 25, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT03237845

Safety and Efficacy in Adult Subjects With Acute Migraines

Primary completionJan 21, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT03235479

Safety and Efficacy Study in Adult Subjects With Acute Migraines

2017

Trial startedAug 30, 2017· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT03266588

Open Label Safety Study in Acute Treatment of Migraine

Trial registeredAug 30, 2017· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT03266588

Open Label Safety Study in Acute Treatment of Migraine

Trial registeredAug 3, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03237845

Safety and Efficacy in Adult Subjects With Acute Migraines

Trial registeredAug 1, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03235479

Safety and Efficacy Study in Adult Subjects With Acute Migraines

Trial startedJul 27, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03237845

Safety and Efficacy in Adult Subjects With Acute Migraines

Trial startedJul 18, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03235479

Safety and Efficacy Study in Adult Subjects With Acute Migraines

2012

Primary completionMay 31, 2012· ClinicalTrials.gov

Phase 2 primary completion: NCT01430442

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

2011

Trial startedOct 31, 2011· ClinicalTrials.gov

Phase 2 trial started: NCT01430442

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Trial registeredSep 8, 2011· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT01430442

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.