{"id":"gonalef-follitropin-alfa","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":{"chemblId":"CHEMBL1201692","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Follitropin alfa binds to FSH receptors on granulosa cells of ovarian follicles, promoting follicular development and estrogen production. This hormone is used in assisted reproductive technology to induce controlled ovarian hyperstimulation, enabling the retrieval of multiple mature oocytes for in vitro fertilization or other fertility treatments.","oneSentence":"Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates the growth and maturation of ovarian follicles in women.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:14:11.268Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infertility in women undergoing assisted reproductive technology (ART)"},{"name":"Anovulation in women with polycystic ovary syndrome (PCOS)"}]},"trialDetails":[{"nctId":"NCT01185782","phase":"PHASE3","title":"SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2007-02","conditions":"Infertility, Ovulation Induction","enrollment":300}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Gonalef®","follitropin alfa","recombinant human follicle-stimulating hormone","r-hFSH","SJ-0021"],"phase":"phase_3","status":"active","brandName":"Gonalef® (Follitropin alfa)","genericName":"Gonalef® (Follitropin alfa)","companyName":"Merck KGaA, Darmstadt, Germany","companyId":"merck-kgaa-darmstadt-germany","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates the growth and maturation of ovarian follicles in women. Used for Infertility in women undergoing assisted reproductive technology (ART), Anovulation in women with polycystic ovary syndrome (PCOS).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}