{"id":"klh-2109-placebo-leurprorelin-acetate","safety":{"commonSideEffects":[{"rate":"50-80","effect":"Hot flashes"},{"rate":"40-70","effect":"Decreased libido"},{"rate":"30-60","effect":"Erectile dysfunction"},{"rate":"10-20","effect":"Injection site reactions"},{"rate":"5-15","effect":"Headache"},{"rate":"10-20","effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Leuprorelin is a synthetic peptide analog of gonadotropin-releasing hormone (GnRH) that initially stimulates the pituitary gland but with continuous exposure causes downregulation of GnRH receptors, resulting in sustained suppression of LH and FSH secretion. This leads to profound reduction in testosterone and estrogen levels. KLH-2109 appears to be a combination study with placebo control and leuprorelin acetate as the active comparator.","oneSentence":"Leuprorelin acetate is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to reduced sex hormone production.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:03.126Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prostate cancer (hormone-sensitive)"},{"name":"Endometriosis"},{"name":"Uterine fibroids"}]},"trialDetails":[{"nctId":"NCT07378098","phase":"PHASE3","title":"to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia","status":"RECRUITING","sponsor":"JW Pharmaceutical","startDate":"2026-01-26","conditions":"Menorrhagia, Uterine Fibroids","enrollment":254}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["KLH-2019 Placebo + Leurprorelin acetate Placebo"],"phase":"phase_3","status":"active","brandName":"KLH-2109 Placebo + Leurprorelin acetate","genericName":"KLH-2109 Placebo + Leurprorelin acetate","companyName":"JW Pharmaceutical","companyId":"jw-pharmaceutical","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Leuprorelin acetate is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to reduced sex hormone production. Used for Prostate cancer (hormone-sensitive), Endometriosis, Uterine fibroids.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}