{"id":"leuprorelin-acetate-depot-3m","safety":{"commonSideEffects":[{"rate":"60-80","effect":"Hot flashes"},{"rate":"10-20","effect":"Injection site reaction"},{"rate":"40-60","effect":"Decreased libido"},{"rate":"30-50","effect":"Erectile dysfunction"},{"rate":"5-15","effect":"Headache"},{"rate":"10-20","effect":"Fatigue"},{"rate":"5-10","effect":"Gynecomastia"},{"rate":"5-15","effect":"Bone pain (flare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Leuprorelin works by binding to GnRH receptors in the pituitary gland, initially causing a surge in LH and FSH (flare effect), followed by sustained suppression of these hormones through receptor desensitization. This results in castration-level testosterone suppression in males and estrogen suppression in females, making it effective for hormone-dependent conditions. The depot formulation provides sustained release over 3 months.","oneSentence":"Leuprorelin acetate is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:40:38.294Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced prostate cancer"},{"name":"Endometriosis"},{"name":"Uterine fibroids"},{"name":"Precocious puberty"}]},"trialDetails":[{"nctId":"NCT05341115","phase":"PHASE4","title":"A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty","status":"COMPLETED","sponsor":"Takeda","startDate":"2023-03-14","conditions":"Central Precocious Puberty","enrollment":80},{"nctId":"NCT05122377","phase":"","title":"RWE About QOL and Compliance of Patients With OFS in China","status":"COMPLETED","sponsor":"Fudan University","startDate":"2022-03-01","conditions":"Breast Cancer, Quality of Life, Hormone Receptor-positive Breast Cancer","enrollment":562},{"nctId":"NCT04891731","phase":"","title":"Efficacy and Safety of Leuprorelin 3M in Premenopausal Women With Hormone Receptor-positive Breast Cancer","status":"UNKNOWN","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2021-05","conditions":"Hormone Receptor-positive Breast Cancer","enrollment":120},{"nctId":"NCT00667446","phase":"PHASE3","title":"Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2008-12","conditions":"Precocious, Leuprolide Acetate, Luteinizing Hormone (LH)","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Leuprolide acetate Depot 3M"],"phase":"marketed","status":"active","brandName":"Leuprorelin Acetate Depot 3M","genericName":"Leuprorelin Acetate Depot 3M","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Leuprorelin acetate is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to reduced testosterone and estrogen production. Used for Advanced prostate cancer, Hormone receptor-positive breast cancer (premenopausal women), Endometriosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}