{"id":"basel-phenotyping-cocktail-capsule","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL206253","moleculeType":"Small molecule","molecularWeight":"578.60"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The Basel phenotyping cocktail is a research tool used to simultaneously evaluate hepatic metabolic capacity by administering multiple substrate drugs that are metabolized by different CYP450 isoforms (CYP3A4, CYP2D6, CYP2C19, CYP2C9, CYP1A2) and other pathways. Plasma and/or urine concentrations of the probe drugs and their metabolites are measured to phenotype an individual's metabolic status, enabling prediction of drug-drug interactions and personalized dosing.","oneSentence":"A diagnostic cocktail containing probe drugs that assess the activity of multiple cytochrome P450 enzymes and other drug-metabolizing pathways in vivo.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T06:29:53.912Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"In vivo phenotyping of cytochrome P450 enzyme activity for drug metabolism assessment"},{"name":"Prediction of drug-drug interactions and personalized medicine applications"}]},"trialDetails":[{"nctId":"NCT03337945","phase":"NA","title":"In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2018-04-04","conditions":"Liver Cirrhosis","enrollment":48},{"nctId":"NCT03247699","phase":"NA","title":"Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2017-06-12","conditions":"CYP450 Phenotyping","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[{"date":"20250821","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20170106","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20101223","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20250821","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20250821","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20250821","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20250821","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20250821","type":"SUPPL","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20091014","type":"ORIG","sponsor":"STRIDES PHARMA","applicationNumber":"ANDA078418"},{"date":"20050615","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19820322","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19970228","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19770803","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19930108","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19821001","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19800506","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19790711","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19970310","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19881118","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19760324","type":"ORIG","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19860701","type":"SUPPL","sponsor":"GE HEALTHCARE","applicationNumber":"NDA017630"},{"date":"19761202","type":"ORIG","sponsor":"KV PHARM","applicationNumber":"ANDA085285"},{"date":"20250624","type":"SUPPL","sponsor":"RISING","applicationNumber":"ANDA202338"},{"date":"20200427","type":"SUPPL","sponsor":"RISING","applicationNumber":"ANDA202338"},{"date":"20130628","type":"ORIG","sponsor":"RISING","applicationNumber":"ANDA202338"},{"date":"20230606","type":"SUPPL","sponsor":"NOVAST LABS","applicationNumber":"ANDA203434"},{"date":"20160930","type":"ORIG","sponsor":"NOVAST LABS","applicationNumber":"ANDA203434"}],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"\"Basel phenotyping cocktail\" capsule","genericName":"\"Basel phenotyping cocktail\" capsule","companyName":"University Hospital, Basel, Switzerland","companyId":"university-hospital-basel-switzerland","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A diagnostic cocktail containing probe drugs that assess the activity of multiple cytochrome P450 enzymes and other drug-metabolizing pathways in vivo. Used for In vivo phenotyping of cytochrome P450 enzyme activity for drug metabolism assessment, Prediction of drug-drug interactions and personalized medicine applications.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}