Drugs / Rimegepant

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Vydura 2022-04-25 europa.eu
Label expansions (2) US (FDA) NURTEC ODT 2021-05-27 – 2022-04-11 fda.gov
Approved US (FDA) NURTEC ODT 2020-02-27 fda.gov

Trials 33 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07667621 Jul 2026 → Jul 2027 expected migraine with aura, migraine without aura University of South Florida Not yet recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07475234 Mar 2026 → Dec 2028 expected pancreatic ductal adenocarcinoma Xiuchao Wang Not yet recruiting No outcome recorded
Phase 28 trials
Phase 2 NCT07613788 May 2026 → Nov 2028 expected large B-cell lymphoma Ruijin Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06999252 Jul 2025 → Dec 2028 expected colon carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT06992674 Jun 2025 → Jun 2026 overdue migraine disorder Second Affiliated Hospital, School of Medicine, Zhejiang University Active not recruiting No outcome recorded
Phase 2 NCT06748664 Jun 2025 → Sep 2026 expected migraine disorder Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 2 NCT06221111 Jun 2024 → May 2025 irritable bowel syndrome Mayo Clinic Completed No outcome recorded
Phase 2 NCT05264714 Sep 2022 → Dec 2025 cluster headache syndrome Mayo Clinic Completed No outcome recorded
Phase 2 NCT04629950 Jan 2021 → Aug 2024 psoriasis Weill Medical College of Cornell University Completed No outcome recorded
Phase 2 NCT01430442 Oct 2011 → May 2012 migraine disorder Pfizer Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07435090 Mar 2026 → Dec 2027 expected peripheral vertigo Shi Tianming Not yet recruiting No outcome recorded
Phase 2/3 NCT03732638 Nov 2018 → Dec 2019 migraine disorder Pfizer Completed No outcome recorded
Phase 2/3 NCT03266588 Aug 2017 → Jul 2019 migraine disorder Pfizer Completed No outcome recorded
Phase 311 trials
Phase 3 NCT06641466 Mar 2025 → Nov 2026 expected migraine disorder Pfizer Recruiting No outcome recorded
Phase 3 NCT06616194 Nov 2024 → Oct 2026 expected migraine disorder Pfizer Recruiting No outcome recorded
Phase 3 NCT05810038 May 2023 → Aug 2025 migraine disorder Pfizer Completed No outcome recorded
Phase 3 NCT05399459 Aug 2022 → Jan 2024 migraine disorder Pfizer Completed No outcome recorded
Phase 3 NCT05399485 Aug 2022 → Jan 2024 migraine disorder Pfizer Completed No outcome recorded
Phase 3 NCT05371652 May 2022 → Feb 2024 migraine disorder Pfizer Completed No outcome recorded
Phase 3 NCT05262517 May 2022 → May 2023 temporomandibular joint disorder Pfizer Terminated No outcome recorded
Phase 3 NCT04743141 Apr 2021 → Jul 2030 expected Pfizer Recruiting No outcome recorded
Phase 3 NCT03461757 Feb → Oct 2018 migraine disorder Pfizer Completed No outcome recorded
Phase 3 NCT03237845 Jul 2017 → Jan 2018 migraine disorder Pfizer Completed No outcome recorded
Phase 48 trials
Phase 4 NCT07685769 Jul 2026 → Jan 2028 expected Pfizer Not yet recruiting No outcome recorded
Phase 4 NCT07609914 May 2026 → May 2028 expected Pfizer Recruiting No outcome recorded
Phase 4 NCT07301008 Sep 2025 → Sep 2026 expected migraine disorder Medstar Health Research Institute Recruiting No outcome recorded
Phase 4 NCT06985342 Jun 2025 → Jan 2026 migraine disorder Icahn School of Medicine at Mount Sinai Terminated No outcome recorded
Phase 4 NCT05518123 Nov 2022 → Mar 2025 migraine disorder Pfizer Completed No outcome recorded
Phase 4 NCT05509400 Oct 2022 → Mar 2025 migraine disorder Pfizer Completed No outcome recorded
Phase 4 NCT05207865 Mar 2022 → Jul 2024 hyperacusis, migraine disorder Pfizer Completed No outcome recorded
Phase 4 NCT05217927 Mar 2022 → Oct 2024 migraine disorder Pfizer Completed No outcome recorded
Phase not stated1 trial
NCT03934086 migraine disorder Pfizer No longer available No outcome recorded
Also used as a comparator or background therapy in 10 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01445067 Comparator Nov 2011 → Sep 2012 migraine disorder Pfizer Completed No outcome recorded
Phase 21 trial
Phase 2 NCT03941834 Comparator Jun 2019 → May 2023 trigeminal neuralgia Pfizer Terminated No outcome recorded
Phase 34 trials
Phase 3 NCT05156398 Comparator Feb 2022 → Nov 2031 expected migraine disorder Pfizer Recruiting No outcome recorded
Phase 3 NCT05248997 Comparator Feb 2022 → Mar 2024 chronic rhinosinusitis Pfizer Completed No outcome recorded
Phase 3 NCT04649242 Comparator Jan 2021 → Jan 2029 expected migraine disorder Pfizer Recruiting No outcome recorded
Phase 3 NCT04574362 Comparator Oct 2020 → Nov 2021 migraine disorder Pfizer Completed No outcome recorded
Phase 44 trials
Phase 4 NCT06473597 Comparator Sep 2024 → Dec 2026 expected migraine disorder Antonios Likourezos Recruiting No outcome recorded
Phase 4 NCT05211154 Comparator May 2022 → Apr 2025 migraine with aura, migraine without aura Danish Headache Center Terminated No outcome recorded
Phase 4 NCT05127486 Comparator Dec 2021 → May 2023 migraine disorder Eli Lilly and Company Completed No outcome recorded
Phase 4 NCT04860713 Comparator Apr 2021 → Sep 2022 Antonios Likourezos Completed No outcome recorded

Press releases naming this drug 5 releases

DateIssuerRelease
2022-04-27 Pfizer Pfizer and Biohaven’s VYDURA® (Rimegepant) Granted First Ever Marketing Authorization by European Commission for Both Acute Treatment of Migraine and Prophylaxis of Episodic Migraine pfizer.com
2022-02-14 Pfizer Biohaven and Pfizer Announce Positive Top-Line Results of Pivotal Trial of Rimegepant for the Acute Treatment of Migraine in China and South Korea pfizer.com
2022-01-05 Pfizer Biohaven and Pfizer Complete Collaboration Transaction for Commercialization of Rimegepant and Zavegepant Outside United States pfizer.com
2021-11-09 Pfizer Biohaven and Pfizer Enter Strategic Collaboration for the Commercialization of Rimegepant Outside the United States pfizer.com
2021-09-08 Teva Branded Pharmaceutical Products R&D, Inc. Late-Breaking Data at the International Headache Society & European Headache Federation Joint Congress 2021 Showed AJOVY® (fremanezumab-vfrm) Injection Reduced More Monthly Migraine Days in a Network Meta-Analysis Study with Atogepant and Rimegepant tevapharm.com

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 45 sources stand behind the page.

FieldValueCited text
Known as Rimegepant Rimegepant (Nurtec ODT) 75 mg orally disintegrating tablets” NCT06473597
41

NCT05127486

NCT06616194

NCT06985342

NCT06748664

NCT07609914

NCT05207865

NCT05810038

NCT05371652

NCT04743141

NCT04629950

NCT05248997

NCT03237845

NCT03732638

NCT05509400

NCT05156398

NCT05217927

NCT04860713

NCT05264714

NCT05399485

NCT05399459

NCT07685769

NCT04649242

NCT01430442

NCT07475234

NCT07301008

NCT03461757

NCT03235479

NCT04574362

NCT06641466

NCT03266588

NCT07435090

NCT03941834

NCT03934086

NCT07613788

NCT06221111

NCT06999252

NCT05262517

NCT05211154

NCT06992674

NCT07667621

NCT05518123

Known as BHV3000 “This trial is to determine whether BHV3000 (rimegepant) 75mg is safe and effictive as a treatment for acute migraine in Chinese and Korean patients” NCT04574362
4

“One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) at the time of their migraine attack” NCT05371652

BHV3000 (rimegepant) 75 mg or 50 mg ODT” NCT04649242

BHV3000 (rimegepant) 75mg tablet” NCT03941834

BHV3000NCT05156398

Known as BMS-927711 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01445067
Known as Nurtec “Drug: Rimegepant 75 MG [Nurtec]” NCT06221111
1

Nurtec (Rimegepant)” NCT04860713

Known as Nurtec odt ChEMBL registry synonym — accepted as the source's own label CHEMBL2178422
Known as PF-07899801 “Rimegepant (PF-07899801)” NCT04743141
Known as Rimegepant hemisulfate sesquihydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL2178422
Known as RIMEGEPANT SULFATE ChEMBL registry synonym — accepted as the source's own label CHEMBL2178422
Known as Vydura ChEMBL registry synonym — accepted as the source's own label CHEMBL2178422
Action Inhibit “Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL2178422
1

“CGRP Antagonist” NCT01445067

Modality Small molecule “Rimegepant, an oral small molecule calcitonin gene-related peptide receptor blocker or antagonist” PMID 41652666 Feb 2026
Route Oral “rimegepant 10 milligram (mg) orally” NCT01430442
Target CALCRL “Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL2178422