{"id":"rimegepant-25-mg","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"P-glycoprotein inhibitors (e.g., cyclosporine, ketoconazole, itraconazole, erythromycin, quinidine, ritonavir, saquinavir)","action":"Monitor","effect":"Increased rimegepant exposure"},{"drug":"P-glycoprotein inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort)","action":"Monitor","effect":"Decreased rimegepant exposure"},{"drug":"Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, ritonavir, saquinavir)","action":"Monitor","effect":"Increased rimegepant exposure"},{"drug":"Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort)","action":"Monitor","effect":"Decreased rimegepant exposure"},{"drug":"CYP3A substrates (e.g., midazolam, triazolam, lovastatin, simvastatin, atorvastatin, fentanyl)","action":"Monitor","effect":"Increased exposure of CYP3A substrates"}],"commonSideEffects":[{"effect":"Nasopharyngitis","drugRate":"1.3%","placeboRate":"","totalAtRisk":239,"totalAffected":3,"trialsReporting":1}],"contraindications":["History of hypersensitivity reaction to rimegepant or any ingredient in the formulation.","Anaphylaxis and delayed serious hypersensitivity have occurred.","Serious hypersensitivity reactions, including anaphylaxis, dyspnea, and rash, reported.","Hypertension development and worsening of pre-existing hypertension reported."],"specialPopulations":{"Pregnancy":"There are no adequate data on the developmental risk associated with the use of rimegepant in pregnant women. In animal studies, oral administration of rimegepant at high doses (300 mg/kg/day; exposures over 200 times that observed in humans administered at the therapeutic dose of 75 mg) during organogenesis resulted in adverse effects on development in rats (decreased fetal body weight and increased incidence of fetal variations). These highest dose  hypertension, adverse birth outcomes, including congenital malformations, or adverse neonatal or neurological outcomes in offspring.","Geriatric use":"text","Paediatric use":"text","Renal impairment":"text","Hepatic impairment":"text"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=rimegepant-25-mg","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:34:40.063477+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:34:46.664393+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:34:40.136305+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rimegepant-25-mg","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:34:47.368761+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":"2026-04-19T23:34:48.852975+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":"2026-04-19T23:34:48.517040+00:00"}},"allNames":"rimegepant 25 mg","offLabel":[],"timeline":[],"aiSummary":"Rimegepant 25 MG, developed by Pfizer Inc., is a small molecule used for the acute treatment of migraine with or without aura in adults and prevention of migraine in adults. It is a first-in-class calcitonin gene-related peptide receptor antagonist. Rimegepant has shown clinical differentiation in its efficacy and safety profile compared to other migraine treatments. Its commercial significance lies in its ability to provide rapid and sustained relief from migraine symptoms. The drug has been marketed and has a moderate revenue stream. There are no notable pipeline developments for rimegepant.","brandName":"Rimegepant 25 MG","ecosystem":[],"isGeneric":true,"mechanism":{"target":"calcitonin gene-related peptide receptor","novelty":"first-in-class","modality":"small molecule","drugClass":"calcitonin gene-related peptide receptor antagonist","explanation":"","oneSentence":"","technicalDetail":"Rimegepant selectively binds to the calcitonin gene-related peptide receptor, inhibiting the receptor's activity and reducing the release of calcitonin gene-related peptide. This action leads to a decrease in pain transmission and inflammation, providing rapid and sustained relief from migraine symptoms. Rimegepant's mechanism of action is distinct from other migraine treatments, making it a valuable option for patients."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=rimegepant-25-mg","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rimegepant-25-mg","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":2,"lastValidatedAt":"2026-04-20T08:34:12.490870+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Ubrogepant (Ubrelvy)","company":"Allergan","advantage":"Does not cause vasoconstriction, making it suitable for patients with cardiovascular risk factors"},{"name":"Zavegepant","company":"Not specified","advantage":"May be considered for patients who don't respond to rimegepant"},{"name":"Lasmiditan (Reyvow)","company":"Eli Lilly","advantage":"Does not cause vasoconstriction and is particularly useful for patients with cardiovascular risk factors where triptans are contraindicated"}],"genericName":"rimegepant-25-mg","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":"NCT05399459","phase":"PHASE3","title":"Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-08-09","conditions":"Migraine","enrollment":897},{"nctId":"NCT01430442","phase":"PHASE2","title":"Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-10","conditions":"Migraine, Acute Treatment of Migraine","enrollment":1026}],"_emaApprovals":[{"date":"","name":"Rimegepant 25 MG","status":"Authorised","regulator":"EMA"}],"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":[],"_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":5,"visitCount":8,"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":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"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":2,"lastValidatedAt":"2026-04-20T08:34:12.490870+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}