{"id":"rimegepant-75-mg","rwe":[{"pmid":"41637861","year":"2026","title":"A pilot, randomized, placebo-controlled trial of rimegepant on visceral sensation and symptoms in nonconstipation IBS pain.","journal":"American journal of physiology. Gastrointestinal and liver physiology"},{"pmid":"41255098","year":"2025","title":"A phase 4, randomized, double-blind, placebo-controlled trial evaluating the efficacy and tolerability of rimegepant for the prevention of episodic migraine in adults with a history of inadequate response to traditional oral preventive medications.","journal":"Cephalalgia : an international journal of headache"},{"pmid":"39766367","year":"2024","title":"Real-World Open-Label Experience with Rimegepant for the Acute Treatment of Migraine Attacks: A Multicenter Pilot Study.","journal":"Brain sciences"},{"pmid":"39762740","year":"2025","title":"Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study).","journal":"The journal of headache and pain"}],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Phase 3 studies ongoing for pediatric acute migraine treatment and long-term safety; formulation development includes orally disintegrating tablet for pediatric administration.","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"active","trials":["NCT03235479","NCT05248997","NCT03732638","NCT05262517","NCT05518123","NCT06616194","NCT03266588","NCT06985342","NCT03934086","NCT05217927","NCT03237845","NCT04629950","NCT04649242","NCT03461757","NCT05399459","NCT04574362","NCT05207865","NCT04743141","NCT05399485","NCT06221111","NCT01430442","NCT07301008","NCT05509400","NCT06641466"],"_pubmed":{"count":55,"papers":[{"date":"2026","pmid":"41779821","title":"Efficacy and safety of rimegepant 75 mg orally disintegrating tablet for the acute treatment of chronic rhinosinusitis in adults: Results from a multicenter, randomized, placebo-controlled, phase 2/3 trial.","authors":"Franjic D","journal":"PloS one"},{"date":"2026 Feb 27","pmid":"41761058","title":"Long-term safety and effectiveness of rimegepant for the preventive treatment of migraine in Japan: an open-label extension of a phase 3 study.","authors":"Matsumori Y","journal":"The journal of headache and pain"},{"date":"2026 Feb 16","pmid":"41699085","title":"The efficacy of rimegepant for the acute treatment of vestibular migraine.","authors":"Chu H","journal":"Scientific reports"},{"date":"2026 Feb 6","pmid":"41652666","title":"Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials.","authors":"Charleston L 4th","journal":"Headache"},{"date":"2026 Apr 1","pmid":"41637861","title":"A pilot, randomized, placebo-controlled trial of rimegepant on visceral sensation and symptoms in nonconstipation IBS pain.","authors":"Halawi H","journal":"American journal of physiology. Gastrointestinal and liver physiology"}]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T22:59:51.681391+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:00:01.276369+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2364629/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T22:59:44.344501+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:02.775139+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:59:41.418282+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:59:43.318861+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:02.775104+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:02.775096+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:02.775034+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:02.775060+00:00"}},"allNames":"rimegepant 75 mg","offLabel":[],"timeline":[{"date":"2015","type":"neutral","milestone":"Phase 2 dose-ranging study initiated for acute migraine treatment","regulator":"none","description":"Biohaven Pharmaceuticals initiated Phase 2 dose-ranging study of rimegepant (BMS-927711) in acute migraine, ultimately enrolling 1,026 subjects."},{"date":"2017","type":"positive","milestone":"Phase 2 dose-ranging study completed; 75 mg dose selected","regulator":"none","description":"Phase 2 study completed with 75 mg identified as optimal dose for efficacy and tolerability in acute migraine treatment."},{"date":"2018","type":"neutral","milestone":"Phase 3 efficacy and safety studies initiated","regulator":"none","description":"Multiple Phase 3 trials initiated including Japanese population study and studies in adults unsuitable for triptans."},{"date":"2019","type":"positive","milestone":"Phase 3 Japanese efficacy and safety study completed","regulator":"none","description":"Phase 3 study in Japanese subjects (N=897) completed, demonstrating efficacy and safety of rimegepant 75 mg for acute migraine treatment."},{"date":"2020","type":"positive","milestone":"Phase 3 chronic rhinosinusitis study completed","regulator":"none","description":"Phase 3 multicenter, randomized, placebo-controlled trial (N=261) completed evaluating rimegepant ODT for acute treatment of chronic rhinosinusitis with and without nasal polyps."},{"date":"2021","type":"neutral","milestone":"Phase 4 episodic migraine prevention studies initiated","regulator":"none","description":"Phase 4 studies initiated to evaluate rimegepant for preventive treatment of episodic migraine with multiple dosing regimens."},{"date":"2022","type":"positive","milestone":"Pfizer acquires Biohaven Pharmaceuticals","regulator":"none","description":"Pfizer completes acquisition of Biohaven Pharmaceuticals, gaining rimegepant and other migraine therapeutics in development."},{"date":"2023","type":"positive","milestone":"Phase 4 episodic migraine prevention study completed","regulator":"none","description":"Phase 4 study of daily dosing rimegepant for episodic migraine prevention (N=441) completed, supporting preventive indication development."},{"date":"2023","type":"positive","milestone":"Phase 4 efficacy and safety study with multiple dosing regimens completed","regulator":"none","description":"Large Phase 4 study (N=1,415) evaluating efficacy and safety of rimegepant with multiple dosing regimens for episodic migraine prevention completed."},{"date":"2024","type":"neutral","milestone":"Phase 3 pediatric acute treatment study recruiting","regulator":"none","description":"Phase 3 long-term safety study of rimegepant in pediatric subjects (N=600) actively recruiting for acute migraine treatment indication."},{"date":"2024","type":"neutral","milestone":"Phase 3 menstrual migraine prevention study recruiting","regulator":"none","description":"Phase 3 study of intermittent rimegepant for menstrual migraine prevention (N=723) actively recruiting."},{"date":"2024","type":"neutral","milestone":"Phase 3 pediatric randomized study recruiting","regulator":"none","description":"Large Phase 3 randomized study in children and adolescents with migraine for acute treatment (N=2,100) actively recruiting."},{"date":"2025","type":"positive","milestone":"Real-world effectiveness study completed","regulator":"none","description":"Prospective real-world study of rimegepant in migraine treatment (N=173) completed at Ruijin-Hainan Hospital, Shanghai."},{"date":"2026","type":"positive","milestone":"Publication: Chronic rhinosinusitis efficacy and safety","regulator":"none","description":"PLoS One publication reporting efficacy and safety of rimegepant 75 mg ODT for acute treatment of chronic rhinosinusitis in multicenter Phase 2/3 trial."},{"date":"2026","type":"positive","milestone":"Publication: Vestibular migraine efficacy","regulator":"none","description":"Scientific Reports publication demonstrating efficacy of rimegepant for acute treatment of vestibular migraine."}],"_drugbank":{"source":"DrugBank","halfLife":"","metabolism":"","proteinBinding":"","bioavailability":""},"aiSummary":"Rimegepant 75 MG is a small molecule that acts as an antagonist to the calcitonin gene-related peptide type 1 receptor. It is used to treat various types of migraines, including episodic migraine, menstrual migraine, migraine with aura, and migraine without aura.","brandName":"Rimegepant 75 MG","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"Calcitonin gene-related peptide (CGRP) receptor","novelty":"best-in-class","modality":"small molecule","drugClass":"CGRP receptor antagonist (gepant)","explanation":"Rimegepant works by blocking the CGRP receptor, a G-protein coupled receptor found on trigeminal sensory neurons and other pain-processing tissues. CGRP is a neuropeptide released during migraine attacks that triggers vasodilation, neuroinflammation, and pain signal amplification. By antagonizing this receptor, rimegepant interrupts the cascade of events that leads to migraine headache, photophobia, phonophobia, and associated symptoms. The drug crosses the blood-brain barrier as a small molecule, allowing it to act on both central and peripheral CGRP receptors. This mechanism differs from monoclonal antibody CGRP antagonists (like erenumab) by offering rapid oral absorption and faster symptom relief, making it suitable for acute migraine treatment rather than prevention alone.","oneSentence":"Rimegepant selectively antagonizes the calcitonin gene-related peptide (CGRP) receptor to block migraine pain signaling.","technicalDetail":"Rimegepant is a potent, selective CGRP receptor antagonist with high oral bioavailability and rapid CNS penetration. The drug exhibits competitive antagonism at the human CGRP receptor with nanomolar affinity, demonstrating selectivity over related receptors. Pharmacokinetic studies show peak plasma concentrations within 1–1.5 hours of oral administration, supporting its use for acute migraine treatment. The 75 mg dose was identified in Phase 2 dose-ranging studies as optimal for efficacy and tolerability in acute migraine."},"chemblData":{"prodrug":0,"chemblId":"CHEMBL2364629","maxPhase":"4.0","chirality":1,"parenteral":false,"availability":1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":true},"commercial":{"notes":"Rimegepant 75 mg remains in preclinical/early development status. Pfizer's migraine portfolio includes other CGRP-targeted therapies. Peak sales potential estimated in hundreds of millions to low billions USD given migraine market size and competitive landscape.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"~39M migraine sufferers globally; ~12M in US","peakSalesEstimate":"","genericCompetition":"no"},"fdaRecalls":[],"references":[],"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-19T23:00:01.276477+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[{"name":"Erenumab (Aimovig)","slug":"erenumab","company":"Amgen","advantage":"Monoclonal antibody CGRP antagonist; FDA-approved for migraine prevention; longer dosing interval (monthly injection)"},{"name":"Fremanezumab (Ajovy)","slug":"fremanezumab","company":"Teva Pharmaceutical","advantage":"Monoclonal antibody CGRP antagonist; FDA-approved for migraine prevention; quarterly or monthly dosing"},{"name":"Galcanezumab (Emgality)","slug":"galcanezumab","company":"Eli Lilly","advantage":"Monoclonal antibody CGRP antagonist; FDA-approved for episodic and chronic migraine prevention; monthly dosing"},{"name":"Ubrogepant (Ubrelvy)","slug":"ubrogepant","company":"Allergan (AbbVie)","advantage":"Oral CGRP receptor antagonist (gepant); FDA-approved for acute migraine treatment; rapid onset; direct competitor in acute treatment segment"},{"name":"Lasmiditan (Reyvow)","slug":"lasmiditan","company":"Eli Lilly","advantage":"5-HT1F receptor agonist; FDA-approved for acute migraine treatment; oral formulation; alternative mechanism to CGRP antagonism"}],"genericName":"rimegepant-75-mg","indications":{"approved":[],"offLabel":[{"name":"Vestibular migraine","notes":"Scientific Reports 2026 publication reports efficacy of rimegepant for acute treatment of vestibular migraine; limited clinical trial data.","evidenceLevel":"limited"},{"name":"Trigger-induced migraine","notes":"Phase 4 recruiting study (N=60) evaluating rimegepant as preemptive treatment for predictable trigger-induced migraine.","evidenceLevel":"moderate"},{"name":"Moderate plaque-type psoriasis","notes":"Completed Phase 2 study (N=41) at Weill Medical College of Cornell University; mechanism unclear, likely exploratory CGRP pathway investigation.","evidenceLevel":"limited"},{"name":"Irritable bowel syndrome pain","notes":"Completed Phase 2 comparison study with placebo (N=24) at Mayo Clinic; CGRP involvement in visceral pain signaling.","evidenceLevel":"limited"}],"pipeline":[{"name":"Acute treatment of migraine with or without aura","notes":"Completed Phase 2 dose-ranging study (N=1026) and Phase 3 efficacy/safety studies in Japanese subjects (N=897) and adults unsuitable for triptans (N=632). Multiple Phase 4 trials completed for acute treatment efficacy and tolerability.","phase":"Phase 3","status":"completed"},{"name":"Preventive treatment of episodic migraine","notes":"Completed Phase 4 study of daily dosing for episodic migraine prevention (N=441) and efficacy/safety study with multiple dosing regimens (N=1415). Ongoing Phase 3 study in adolescents with frequent migraine (N=200).","phase":"Phase 4","status":"completed"},{"name":"Preventive treatment of menstrual migraine","notes":"Recruiting Phase 3 study of intermittent rimegepant for menstrual migraine prevention (N=723).","phase":"Phase 3","status":"recruiting"},{"name":"Acute treatment of migraine in pediatric subjects","notes":"Recruiting Phase 3 long-term safety study in pediatric subjects (N=600) and randomized study in children and adolescents (N=2100).","phase":"Phase 3","status":"recruiting"},{"name":"Acute treatment of chronic rhinosinusitis with and without nasal polyps","notes":"Completed Phase 3 multicenter, randomized, placebo-controlled trial (N=261) evaluating rimegepant orally disintegrating tablet for CRS.","phase":"Phase 3","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💊","route":"oral","frequency":"As needed for acute migraine; daily dosing for preventive regimens under investigation","formulation":"Orally disintegrating tablet (ODT)"},"_hyperScrapedAt":"2026-03-27T18:00:58.930561","crossReferences":{"chemblId":"CHEMBL2364629"},"formularyStatus":[],"chemblMechanisms":[{"actionType":"ANTAGONIST","targetChemblId":"CHEMBL3798","mechanismComment":"Therapeutic mechanism not fully elucidated.","mechanismOfAction":"Calcitonin gene-related peptide type 1 receptor antagonist"}],"developmentCodes":[],"ownershipHistory":[{"notes":"Pfizer acquired rimegepant through acquisition of Biohaven Pharmaceuticals in 2022; Biohaven originally developed the compound.","period":"2019–present","companyName":"Pfizer Inc.","relationship":"Originator"}],"publicationCount":55,"therapeuticAreas":["Neuroscience"],"trialPhaseCounts":{"":5,"PHASE2":3,"PHASE3":11,"PHASE4":7,"PHASE1, PHASE2":1,"PHASE2, PHASE3":1},"biosimilarFilings":[],"firstApprovalDate":"","recentPublications":[{"pmid":"41779821","title":"Efficacy and safety of rimegepant 75 mg orally disintegrating tablet for the acute treatment of chronic rhinosinusitis in adults: Results from a multicenter, randomized, placebo-controlled, phase 2/3 trial.","authors":"Franjic D, Fountaine RJ, Nalpas C, Goswami B, Fullerton T","journal":"PLoS One","pubDate":"2026"},{"pmid":"40734466","title":"A randomized open-label study to evaluate the effectiveness and safety of once-daily rimegepant 75 mg orally disintegrating tablet for the short-term preventive treatment of fasting-triggered headache in individuals with migraine.","authors":"Alsaadi T, Suliman R, Yang J, Agarwal E, Fullerton T","journal":"Cephalalgia","pubDate":"2025 Jul"},{"pmid":"40492651","title":"Efficacy and safety of rimegepant 75 mg for acute treatment of migraine: a pooled analysis of four randomized, placebo-controlled trials.","authors":"Tepper SJ, Pavlovic JM, Yu S, Lipton RB, Pixton G","journal":"Postgrad Med","pubDate":"2025 Aug"},{"pmid":"39650209","title":"Erratum: Efficacy and Safety of Rimegepant 75 Mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial [Corrigendum].","authors":"","journal":"J Pain Res","pubDate":"2024"},{"pmid":"39070853","title":"Efficacy and Safety of Rimegepant 75 mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial.","authors":"Lipton RB, Thiry A, Morris BA, Croop R","journal":"J Pain Res","pubDate":"2024"},{"pmid":"38764606","title":"Long-Term Use of Rimegepant 75 mg for the Acute Treatment of Migraine is Associated with a Reduction in the Utilization of Select Analgesics and Antiemetics.","authors":"Fullerton T, Pixton G","journal":"J Pain Res","pubDate":"2024"},{"pmid":"37904724","title":"The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75 mg Are Similar in Elderly and Nonelderly Adults: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study.","authors":"Bhardwaj R, Morris B, Bertz R, Croop R, Liu J","journal":"Clin Pharmacol Drug Dev","pubDate":"2024 Jan"},{"pmid":"37650695","title":"Correction to Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1,Open-Label, Single-Dose, Parallel-Group Study.","authors":"","journal":"Clin Pharmacol Drug Dev","pubDate":"2023 Oct"},{"pmid":"37140071","title":"Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants.","authors":"Bhardwaj R, Stringfellow JC, Morris B, Croop RS, Bertz RJ","journal":"Headache","pubDate":"2023 May"},{"pmid":"37073443","title":"Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study.","authors":"Bhardwaj R, Ivans A, Stringfellow J, Morris B, Coric V","journal":"Clin Pharmacol Drug Dev","pubDate":"2023 Aug"}],"_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"participantFlowData":[],"companionDiagnostics":[],"firstApprovalCountry":null,"structuredTrialResults":[],"genericManufacturerList":[],"modality":"small molecule","enrichmentLevel":5,"visitCount":8,"trialStats":{"total":3,"withResults":1},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-19T23:00:01.276477+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":false,"score":1}}