{"id":"relugolix-combination-tablet","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Hot flashes"},{"rate":"10-20%","effect":"Musculoskeletal pain"},{"rate":"10-20%","effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By inhibiting GnRH receptors, relugolix combination tablet effectively suppresses the production of LH and FSH, which are essential for the production of testosterone. This reduction in testosterone levels can help alleviate symptoms associated with conditions such as prostate cancer. The combination of relugolix with other medications, such as estradiol, further enhances the therapeutic effect.","oneSentence":"Relugolix combination tablet works by inhibiting gonadotropin-releasing hormone (GnRH) receptors, leading to a decrease in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) production, which in turn reduces testosterone levels.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:31:49.223Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prostate cancer"},{"name":"Endometriosis"}]},"trialDetails":[{"nctId":"NCT06631521","phase":"PHASE1","title":"Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer","status":"RECRUITING","sponsor":"AdventHealth","startDate":"2024-10-22","conditions":"Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery","enrollment":30},{"nctId":"NCT04756037","phase":"PHASE3","title":"Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sumitomo Pharma Switzerland GmbH","startDate":"2021-03-18","conditions":"Contraception","enrollment":1020},{"nctId":"NCT06922318","phase":"PHASE2","title":"The COSMYC Trial (COmbined Suppression of MYC)","status":"RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2025-08-19","conditions":"Metastatic Castration-resistant Prostate Cancer","enrollment":50},{"nctId":"NCT06279195","phase":"PHASE2","title":"Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment","status":"WITHDRAWN","sponsor":"Endeavor Health","startDate":"2024-06-01","conditions":"Pelvic Pain","enrollment":""},{"nctId":"NCT04666129","phase":"PHASE1","title":"Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2021-02-18","conditions":"Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer","enrollment":48},{"nctId":"NCT05862272","phase":"PHASE3","title":"A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis","status":"RECRUITING","sponsor":"Sumitomo Pharma Switzerland GmbH","startDate":"2023-08-14","conditions":"Uterine Fibroids, Endometriosis","enrollment":1000},{"nctId":"NCT06439524","phase":"PHASE3","title":"The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial","status":"RECRUITING","sponsor":"Main Line Health","startDate":"2024-08-15","conditions":"Endometriosis","enrollment":110},{"nctId":"NCT05679388","phase":"PHASE1","title":"A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients","status":"TERMINATED","sponsor":"University of Chicago","startDate":"2023-02-13","conditions":"Prostate Cancer, Prostate Cancer Metastatic, Prostate Adenocarcinoma","enrollment":60},{"nctId":"NCT03751124","phase":"PHASE3","title":"Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2018-10-16","conditions":"Uterine Leiomyoma, Uterine Fibroids","enrollment":229},{"nctId":"NCT03412890","phase":"PHASE3","title":"LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"Myovant 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Menstrual Bleeding, Uterine Fibroid","enrollment":388},{"nctId":"NCT04714554","phase":"PHASE1","title":"A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2021-01-06","conditions":"Healthy","enrollment":43},{"nctId":"NCT04978688","phase":"PHASE1","title":"Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2016-06-16","conditions":"Healthy","enrollment":48},{"nctId":"NCT03204331","phase":"PHASE3","title":"SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-11-01","conditions":"Endometriosis Related Pain","enrollment":623},{"nctId":"NCT03204318","phase":"PHASE3","title":"SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-12-07","conditions":"Endometriosis Related Pain","enrollment":638},{"nctId":"NCT02093390","phase":"PHASE1","title":"A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects","status":"COMPLETED","sponsor":"Millennium Pharmaceuticals, Inc.","startDate":"2014-03","conditions":"Prostate Cancer, Endometriosis","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["TAK-385","T-1331285","RVT-601","MVT-601","MVT-601A"],"phase":"phase_3","status":"active","brandName":"Relugolix Combination Tablet","genericName":"Relugolix Combination Tablet","companyName":"Sumitomo Pharma Switzerland GmbH","companyId":"sumitomo-pharma-switzerland-gmbh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Relugolix combination tablet works by inhibiting gonadotropin-releasing hormone (GnRH) receptors, leading to a decrease in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) production, which in turn reduces testosterone levels. Used for Prostate cancer, Endometriosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}