Drugs / Rimegepant
Rimegepant
also known as
BHV3000 · Nurtec · BMS-927711 · Nurtec odt · PF-07899801 · Rimegepant hemisulfate sesquihydrate · RIMEGEPANT SULFATE · Vydura
Small molecule targets CALCRL via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 2 milestones | |||||
| Filed | US (FDA) | NURTEC ODT | migraine disorder | 2020-12-01 | “NURTEC™ ODT（rimegepant ）を本年 3 月に米国で発売するとともに 、片頭痛の予防的治療を適応とす る適応追加申請（sNDA ）を提出しており” nxera.life ↗ |
| Filed | EU (EMA) | — | migraine disorder | — | “An application for the approval of rimegepant is currently under review by the European Medicines Agency” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07835035 | Jul 2026 → Feb 2027 expected | urothelial carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| 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 210 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT07812467 | Oct 2026 → Oct 2028 expected | oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07795125 | Sep 2026 → Mar 2031 expected | endometriosis | Mayo Clinic | Not yet recruiting | No outcome recorded |
| 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 overdue | 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 | Missed primary |
| 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 | Missed primary |
| Phase 2 | NCT01430442 | Oct 2011 → May 2012 | migraine disorder | Pfizer | Completed | Met primary |
| Phase 2/33 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 2/3 | NCT03266588 | Aug 2017 → Jul 2019 | migraine disorder | Pfizer | Completed | No outcome recorded |
| Phase 312 trials · 5 met primary · 1 missed | ||||||
| Phase 3 | NCT07729462 | Aug 2026 → Oct 2028 expected | — | Pfizer | Recruiting | No outcome recorded |
| 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 | NCT05399485 | Aug 2022 → Jan 2024 | migraine disorder | Pfizer | Completed | Met primary |
| Phase 3 | NCT05399459 | Aug 2022 → Jan 2024 | migraine disorder | Pfizer | Completed | Met primary |
| 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 | Missed primary Stop: Business |
| Phase 3 | NCT04743141 | Apr 2021 → Jul 2030 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT03461757 | Feb → Oct 2018 | migraine disorder | Pfizer | Completed | Met primary |
| Phase 3 | NCT03237845 | Jul 2017 → Jan 2018 | migraine disorder | Pfizer | Completed | Met primary |
| Phase 3 | NCT03235479 | Jul 2017 → Jan 2018 | migraine disorder | Pfizer | Completed | Met primary |
| Phase 48 trials · 3 met primary | ||||||
| Phase 4 | NCT07685769 | Jul 2026 → Jan 2028 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 4 | NCT07609914 | May 2026 → Jun 2028 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 4 | NCT07301008 | Sep 2025 → Sep 2026 overdue | 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 | Met primary |
| Phase 4 | NCT05509400 | Oct 2022 → Mar 2025 | migraine disorder | Pfizer | Completed | Met primary |
| 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 | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT03934086 | — | migraine disorder | Pfizer | No longer available | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT01445067 Comparator | Nov 2011 → Sep 2012 | migraine disorder | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03941834 Comparator | Jun 2019 → May 2023 | trigeminal neuralgia | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05156398 Comparator | Feb 2022 → Mar 2029 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 4 | NCT06473597 Comparator | Sep 2024 → Dec 2028 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 Stop: Enrollment |
| Phase 4 | NCT05127486 Comparator | Dec 2021 → May 2023 | migraine disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT04860713 Comparator | Apr 2021 → Sep 2022 | — | Antonios Likourezos | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-05-31 | NATCO Pharma Ltd. | Regulatory Natco Pharma Limited announces submission of Abbreviated New Drug Application natcopharma.co.in ↗
NATCO Pharma Limited announces submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Rimegepant Sulfate tablet Eq 75mg base strength. |
| 2023-06-16 | Eli Lilly and Company | Results First-Of-Its-Kind Head-to-Head Clinical Trial Reaffirms the Efficacy of Emgality in Episodic Migraine Prevention lilly.com ↗
Emgality did not meet the study's primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. |
| 2022-04-27 | Pfizer | Regulatory 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 ↗
VYDURA ® , an orally disintegrating tablet, is the first medicine approved for both acute and prophylactic treatment of migraine in the European Union (EU). |
| 2022-02-25 | Pfizer | Regulatory Biohaven and Pfizer Receive Positive CHMP Opinion for Migraine Treatment pfizer.com ↗
The CHMP’s positive opinion will now be reviewed by the European Commission (EC). |
| 2022-02-14 | Pfizer | Results 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 ↗
The study met its co-primary endpoints of freedom from pain (p<0.0001) and freedom from most bothersome migraine‐associated symptom (MBS) including nausea, phonophobia or photophobia (p<0.0001) at 2-hours following a single oral dose of rimegepant. |
| 2021-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗ |
| 2021-06-03 | Eli Lilly and Company | Results Lilly Reveals Critical Barriers to Optimal Migraine Care and Insights From Novel Clinical and Patient-Centric Real-World Evidence, Supporting Lilly's Preventive and Acute Treatment Portfolio at AHS 2021 lilly.com ↗
people taking 100 mg and 200 mg doses of REYVOW® (lasmiditan) C-V had greater odds of early onset of efficacy compared to those taking Nurtec® (rimegepant) or UBRELVY® (ubrogepant). |
All press releases naming this drug 12 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rimegepant | “Rimegepant (Nurtec ODT) 75 mg orally disintegrating tablets” NCT06473597 ↗ |
| 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 ↗ “BHV3000” NCT05156398 ↗ |
| 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 ↗ |