{"id":"follitropin-alfa-primapur","safety":{"commonSideEffects":[{"rate":null,"effect":"Ovarian hyperstimulation syndrome (OHSS)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Abdominal pain/bloating"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Follitropin alfa binds to FSH receptors on granulosa cells of ovarian follicles, promoting follicular growth, maturation, and increased estradiol secretion. This hormone replacement therapy mimics the natural FSH surge needed to initiate and sustain the follicular phase of the menstrual cycle, enabling controlled ovarian stimulation for assisted reproductive technologies.","oneSentence":"Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women undergoing fertility treatment.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:20.135Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ovulation induction and controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART)"},{"name":"Anovulation or oligo-ovulation in women with polycystic ovary syndrome (PCOS) or other fertility disorders"}]},"trialDetails":[{"nctId":"NCT03088137","phase":"PHASE3","title":"Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment","status":"COMPLETED","sponsor":"IVFarma LLC","startDate":"2017-02-08","conditions":"Infertility, Female","enrollment":118},{"nctId":"NCT04854707","phase":"","title":"An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data","status":"COMPLETED","sponsor":"IVFarma LLC","startDate":"2020-01-12","conditions":"Reproductive Issues, Reproductive Disorder, Fertility Disorders","enrollment":5484},{"nctId":"NCT03857230","phase":"PHASE1","title":"The Safety and Pharmacokinetics of Primapur and Gonal-f","status":"COMPLETED","sponsor":"IVFarma LLC","startDate":"2015-10-29","conditions":"Area Under Curve, Pharmacokinetics, Absorption","enrollment":28}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Follitropin alpha","Follitropin"],"phase":"phase_3","status":"active","brandName":"Follitropin alfa (Primapur)","genericName":"Follitropin alfa (Primapur)","companyName":"IVFarma LLC","companyId":"ivfarma-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women undergoing fertility treatment. Used for Ovulation induction and controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART), Anovulation or oligo-ovulation in women with polycystic ovary syndrome (PCOS) or other fertility disorders.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}