Clinical Trials

Numerous clinical trials evaluate the therapeutic utility of rimegepant for the acute and preventive management of various migraine subtypes—including chronic, vestibular, pediatric, and trigger-induced—alongside non-migraine conditions such as temporomandibular disorders, trigeminal neuralgia, and endometriosis-related pain. Spanning Phase 1 through Phase 4, these investigations encompass actively recruiting, completed, and terminated protocols. Sponsored by pharmaceutical companies, university hospitals, and neurological institutes globally, these studies seek to establish rimegepant's efficacy, safety, and real-world outcomes across diverse patient populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05156398 RECRUITING
Migraine
Pfizer
 2022-02-28 PHASE3
NCT07795125 NOT_YET_RECRUITING
Endometriosis; Endometriosis-related Pain
Mayo Clinic
 2026-09-30 PHASE2
NCT04743141 RECRUITING
Acute Treatment of Migraine
Pfizer
 2021-04-28 PHASE3
NCT04649242 RECRUITING
Pediatric Migraine
Pfizer
 2021-01-15 PHASE3
NCT06999252 NOT_YET_RECRUITING
Colon Cancer
Fudan University
 2025-07-01 PHASE2
NCT07475234 NOT_YET_RECRUITING
Metastatic Pancreatic Ductal Adenocarcinoma
Xiuchao Wang
 2026-03 PHASE1; PHASE2
NCT07613788 NOT_YET_RECRUITING
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Ruijin Hospital
 2026-05 PHASE2
NCT07729462 NOT_YET_RECRUITING
Preventive Treatment of Migraine
Pfizer
 2026-07-29 PHASE3
NCT06616194 ACTIVE_NOT_RECRUITING
Migraine
Pfizer
 2024-11-15 PHASE3
NCT07609914 RECRUITING
Acute Treatment of Migraine
Pfizer
 2026-05-28 PHASE4
NCT07685769 RECRUITING
Acute Treatment of Migraine
Pfizer
 2026-07-24 PHASE4
NCT07751497 NOT_YET_RECRUITING
Vestibular Migraine
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2026-12-01 PHASE2
NCT07435090 NOT_YET_RECRUITING
Dizziness
Shi Tianming
 2026-03-20 PHASE2; PHASE3
NCT07667621 NOT_YET_RECRUITING
Migraine; Migraine Disease; Migraine in Adults; Migraine Headache; Acute Migraine; Migraine Without Aura; Migraine With Aura
University of South Florida
 2026-07 PHASE1
NCT06473597 RECRUITING
Migraine
Antonios Likourezos
 2024-09-01 PHASE4
NCT06641466 RECRUITING
Menstrual Migraine
Pfizer
 2025-03-11 PHASE3
NCT06748664 NOT_YET_RECRUITING
Vestibular Migraine; Adults 18 Years and Older (no Other Exclusion Criteria)
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-06-01 PHASE2
NCT07301008 RECRUITING
Migraine; Trigger Induced Migraine
Medstar Health Research Institute
 2025-09-09 PHASE4
NCT06992674 ACTIVE_NOT_RECRUITING
Vestibular Migraine
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-06-01 PHASE2
NCT06985342 TERMINATED
Migraine Headaches
Icahn School of Medicine at Mount Sinai
 2025-06-05 PHASE4
NCT05264714 COMPLETED
Cluster Headache
Mayo Clinic
 2022-09-07 PHASE2
NCT05810038 COMPLETED
Migraine
Pfizer
 2023-05-15 PHASE3
NCT06221111 COMPLETED
Irritable Bowel Syndrome
Mayo Clinic
 2024-06-06 PHASE2
NCT05211154 TERMINATED
Migraine With Aura; Migraine Without Aura
Danish Headache Center
 2022-05-05 PHASE4
NCT05518123 COMPLETED
Migraine
Pfizer
 2022-11-07 PHASE4
NCT05509400 COMPLETED
Migraine
Pfizer
 2022-10-18 PHASE4
NCT05217927 COMPLETED
Migraine
Pfizer
 2022-03-04 PHASE4
NCT04629950 COMPLETED
Psoriasis
Weill Medical College of Cornell University
 2021-01-19 PHASE2
NCT05207865 COMPLETED
Migraine; Episodic Migraine; Phonophobia; Photophobia
Pfizer
 2022-03-15 PHASE4
NCT05248997 COMPLETED
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Pfizer
 2022-02-17 PHASE3
NCT06409832 Recruiting
Migraine|Migraine With Aura|Migraine Without Aura|Chronic Migraine
University of Florence|IRCCS National Neurological Institute C. Mondino Foundation|Società italiana per lo studio delle Cefalee (SISC)|Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari|Università degli Studi dell''Aquila|University of Roma La Sapienza|Azienda Ospedaliero Universitaria Policlinico Modena|Ospedale di Piove di Sacco|Azienda Ospedaliero-Universitaria di Parma|Azienda Ospedaliera S. Maria della Misericordia|Azienda Ospedaliera Città della Salute e della Scienza di Torino|Cliniche Humanitas Gavazzeni|University of Campania Luigi Vanvitelli|Ospedale di Prato|Azienda Policlinico Umberto I|Auxologico San Luca Milano|ASST Spedali Civili Brescia|Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
 2024-03-26 --
NCT05371652 COMPLETED
Acute Migraine
Pfizer
 2022-05-19 PHASE3
NCT05399459 COMPLETED
Migraine
Pfizer
 2022-08-09 PHASE3
NCT05399485 COMPLETED
Migraine
Pfizer
 2022-08-09 PHASE3
NCT05888766 Not yet recruiting
Migraine Disorders
University of Roma La Sapienza
 2023-07-01 --
NCT05127486 COMPLETED
Migraine; Episodic Migraine
Eli Lilly and Company
 2021-12-06 PHASE4
NCT05262517 TERMINATED
Temporomandibular Disorders (TMD)
Pfizer
 2022-05-05 PHASE3
NCT03941834 TERMINATED
Trigeminal Neuralgia
Pfizer
 2019-06-25 PHASE2
NCT05518123 Recruiting
Migraine
Pfizer
 2022-11-07 Phase 4
NCT05509400 Recruiting
Migraine
Pfizer
 2022-10-18 Phase 4
NCT04860713 COMPLETED
Pain
Antonios Likourezos
 2021-04-22 PHASE4
NCT05399485 Active not recruiting
Migraine
Pfizer
 2022-08-09 Phase 3
NCT05262517 Terminated
Temporomandibular Disorders (TMD)
Pfizer
 2022-05-05 Phase 3
NCT04574362 COMPLETED
Acute Migraine
Pfizer
 2020-10-22 PHASE3
NCT03732638 COMPLETED
Migraine
Pfizer
 2018-11-14 PHASE2; PHASE3
NCT03266588 COMPLETED
Migraine, With or Without Aura
Pfizer
 2017-08-30 PHASE2; PHASE3
NCT03461757 COMPLETED
Migraine, With or Without Aura
Pfizer
 2018-02-27 PHASE3
NCT03237845 COMPLETED
Migraine, With or Without Aura
Pfizer
 2017-07-27 PHASE3
NCT03235479 COMPLETED
Migraine, With or Without Aura
Pfizer
 2017-07-18 PHASE3
NCT01445067 COMPLETED
Migraine
Pfizer
 2011-11 PHASE1
NCT01430442 COMPLETED
Migraine; Acute Treatment of Migraine
Pfizer
 2011-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the BMS-927711 (Rimegepant) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rimegepant acts as a potent, competitive antagonist of the human calcitonin gene-related peptide (CGRP) receptor with high affinity, thereby blocking CGRP-stimulated intracellular signaling cascades and subsequent neurogenic cranial vasodilation. This targeted inhibition suppresses neurogenic inflammation and trigeminovascular pain transmission, providing therapeutic efficacy in clinical trial settings for the acute and preventive management of migraine and associated pain disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.