{"id":"rimegepant-75-mg-odt","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"P-glycoprotein inhibitors (e.g., cyclosporine, ketoconazole)","action":"Monitor","effect":"Increased rimegepant exposure"},{"drug":"P-glycoprotein inducers (e.g., rifampin, St. John's Wort)","action":"Monitor","effect":"Decreased rimegepant exposure"},{"drug":"CYP3A4 inhibitors (e.g., ketoconazole, itraconazole)","action":"Monitor","effect":"Increased rimegepant exposure"},{"drug":"CYP3A4 inducers (e.g., rifampin, St. John's Wort)","action":"Monitor","effect":"Decreased rimegepant exposure"},{"drug":"Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole)","action":"Avoid","effect":"Increased risk of adverse reactions"},{"drug":"Strong CYP3A4 inducers (e.g., rifampin, St. John's Wort)","action":"Avoid","effect":"Decreased efficacy"}],"commonSideEffects":[],"contraindications":["Patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or to any of its components.","Do not take NURTEC ODT if you are: •allergic to rimegepant, NURTEC ODT, or any of the ingredients in NURTEC ODT.","•have high blood pressure.","•have circulation problems in your fingers and toes.","•have liver problems.","•have kidney problems."],"specialPopulations":{"Pregnancy":"Use should be avoided. AU TGA pregnancy category: B1. US FDA pregnancy category: Not assigned. Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk. Comments: -A pregnancy exposure registry is available. Animal studies have revealed evidence of embryofetal toxicity and teratogenicity.","Breastfeeding":"Use is considered acceptable for mothers of older infants. Excreted into human milk: Yes. Comments: -An alternate drug may be preferred while nursing a newborn or preterm infant. -There are no data on the effects of this drug on the breastfed infant or its effects on milk production.","Geriatric use":"Not mentioned","Paediatric use":"Not mentioned","Renal impairment":"Not mentioned","Hepatic impairment":"Not mentioned"}},"trials":[],"_chembl":null,"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=rimegepant-75-mg-odt","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:53:01.172199+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:53:08.211421+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:53:01.199530+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rimegepant-75-mg-odt","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:53:08.853493+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Calcitonin gene-related peptide type 1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:53:09.749132+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2364629/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:53:09.655955+00:00"}},"allNames":"rimegepant 75 mg odt","offLabel":[],"timeline":[],"_dailymed":null,"aiSummary":"Rimegepant-75-mg-odt, developed by Pfizer Inc., is a small molecule targeting CGRP receptors. It is used for the acute treatment of migraine with or without aura in adults and prevention of migraine in adults. Rimegepant-75-mg-odt has shown clinical differentiation through its efficacy and safety profile. Its commercial significance is evident with $21.2B in revenue. There are 14 trials conducted on this drug. The pipeline developments for rimegepant-75-mg-odt are not specified.","brandName":"rimegepant 75 mg ODT","ecosystem":[],"isGeneric":true,"mechanism":{"target":"CGRP receptors","novelty":"best-in-class","modality":"small molecule","drugClass":"CGRP receptor antagonist","explanation":"","oneSentence":"","technicalDetail":"Rimegepant-75-mg-odt selectively binds to the CGRP receptor, preventing the action of CGRP and thereby reducing migraine symptoms. This action is specific to the CGRP receptor, minimizing potential side effects. The efficacy of rimegepant-75-mg-odt has been demonstrated in clinical trials."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:28:54.643Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$21.2B","peakSalesEstimate":"$21.2B"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=rimegepant-75-mg-odt","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rimegepant-75-mg-odt","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:53:11.510878+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Ubrelvy (ubrogepant)","company":"prescription medicine","advantage":"works by blocking the calcitonin gene-related peptide (CGRP) receptor"},{"name":"Sumatriptan","company":"n/a","advantage":"n/a"},{"name":"Nurtec ODT","company":"n/a","advantage":"n/a"},{"name":"Imitrex","company":"n/a","advantage":"n/a"},{"name":"Rizatriptan","company":"n/a","advantage":"n/a"},{"name":"Botox","company":"n/a","advantage":"n/a"},{"name":"Topiramate","company":"anticonvulsant","advantage":"used to treat partial-onset and tonic-clonic seizures and Lennox-Gastaut syndrome in adults and children aged 2 and older, and to prevent migraines in those aged 12"}],"genericName":"rimegepant-75-mg-odt","indications":{"approved":[{"name":"Acute treatment of migraine with or without aura in adults","regulator":"FDA"},{"name":"Prevention of migraine in adults","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04743141","phase":"PHASE3","title":"Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine","status":"RECRUITING","sponsor":"Pfizer","startDate":"2021-04-28","conditions":"Acute Treatment of Migraine","enrollment":600},{"nctId":"NCT06641466","phase":"PHASE3","title":"A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine","status":"RECRUITING","sponsor":"Pfizer","startDate":"2025-03-11","conditions":"Menstrual Migraine","enrollment":723},{"nctId":"NCT04649242","phase":"PHASE3","title":"Randomized Study in Children and Adolescents With Migraine: Acute Treatment","status":"RECRUITING","sponsor":"Pfizer","startDate":"2021-01-15","conditions":"Pediatric Migraine","enrollment":2100},{"nctId":"NCT05709106","phase":"","title":"A Prospective Real World Study of Rimegepant in the Treatment of Migraine","status":"COMPLETED","sponsor":"Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine","startDate":"2023-01-11","conditions":"Migraine","enrollment":173},{"nctId":"NCT07301008","phase":"PHASE4","title":"Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US","status":"RECRUITING","sponsor":"Medstar Health Research Institute","startDate":"2025-09-09","conditions":"Migraine, Trigger Induced Migraine","enrollment":60},{"nctId":"NCT05217927","phase":"PHASE4","title":"Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-03-04","conditions":"Migraine","enrollment":1415},{"nctId":"NCT05207865","phase":"PHASE4","title":"Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-03-15","conditions":"Migraine, Episodic Migraine, Phonophobia","enrollment":441},{"nctId":"NCT05509400","phase":"PHASE4","title":"Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-10-18","conditions":"Migraine","enrollment":632},{"nctId":"NCT05518123","phase":"PHASE4","title":"Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-11-07","conditions":"Migraine","enrollment":658},{"nctId":"NCT06985342","phase":"PHASE4","title":"Acute Migraine Treatment in the ED With Gepants","status":"RECRUITING","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2025-06-05","conditions":"Migraine Headaches","enrollment":100},{"nctId":"NCT06221111","phase":"PHASE2","title":"Comparison of Rimegepant and Placebo for Pain in IBS","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2024-06-06","conditions":"Irritable Bowel Syndrome","enrollment":24},{"nctId":"NCT05248997","phase":"PHASE3","title":"Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-02-17","conditions":"Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps","enrollment":261},{"nctId":"NCT05262517","phase":"PHASE3","title":"Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders","status":"TERMINATED","sponsor":"Pfizer","startDate":"2022-05-05","conditions":"Temporomandibular Disorders (TMD)","enrollment":126},{"nctId":"NCT03461757","phase":"PHASE3","title":"Trial in Adult Subjects With Acute Migraines","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-02-27","conditions":"Migraine, With or Without Aura","enrollment":1811}],"_emaApprovals":[{"date":"","name":"rimegepant 75 mg ODT","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":true,"chemblId":"CHEMBL2364629","moleculeType":"Small molecule","molecularWeight":"1221.26"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL2364629"},"formularyStatus":[],"_approvalHistory":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":3,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":1,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:53:11.510878+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}