{"id":"fcn-437c-fulvestrant-goserelin-acetate","safety":{"commonSideEffects":[{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Vaginal dryness"},{"rate":null,"effect":"Arthralgia"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades the estrogen receptor, blocking estrogen-driven proliferation. Goserelin is a GnRH agonist that suppresses ovarian estrogen production by downregulating the hypothalamic-pituitary-gonadal axis. Together, they provide dual suppression of estrogen signaling through receptor degradation and hormonal suppression.","oneSentence":"This combination therapy uses an estrogen receptor degrader (fulvestrant) and a gonadotropin-releasing hormone agonist (goserelin) to suppress estrogen signaling in hormone receptor-positive breast cancer.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:18.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women"}]},"trialDetails":[{"nctId":"NCT05438810","phase":"PHASE3","title":"This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.","status":"UNKNOWN","sponsor":"Ahon Pharmaceutical Co., Ltd.","startDate":"2022-01-18","conditions":"Advanced Breast Cancer, Female Breast Cancer","enrollment":312},{"nctId":"NCT05004142","phase":"PHASE2","title":"Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin","status":"UNKNOWN","sponsor":"Ahon Pharmaceutical Co., Ltd.","startDate":"2020-06-30","conditions":"Breast Neoplasms","enrollment":70}],"_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":[],"phase":"phase_3","status":"active","brandName":"FCN-437c,Fulvestrant,Goserelin acetate","genericName":"FCN-437c,Fulvestrant,Goserelin acetate","companyName":"Ahon Pharmaceutical Co., Ltd.","companyId":"ahon-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination therapy uses an estrogen receptor degrader (fulvestrant) and a gonadotropin-releasing hormone agonist (goserelin) to suppress estrogen signaling in hormone receptor-positive breast cancer. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}