{"id":"obe2109","safety":{"commonSideEffects":[{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Amenorrhea"},{"rate":null,"effect":"Vaginal bleeding abnormalities"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OBE2109 acts as a selective progesterone receptor agonist/modulator, targeting the progesterone receptor to regulate endometrial and ovarian function. This mechanism is designed to address conditions related to abnormal uterine bleeding and reproductive dysfunction by modulating the effects of progesterone in target tissues.","oneSentence":"OBE2109 is a selective progesterone receptor modulator that modulates progesterone signaling to treat reproductive and gynecological disorders.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:23:47.492Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Uterine fibroids (heavy menstrual bleeding)"},{"name":"Endometriosis-associated pain"}]},"trialDetails":[{"nctId":"NCT02778399","phase":"PHASE2","title":"A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis","status":"COMPLETED","sponsor":"ObsEva SA","startDate":"2016-07","conditions":"Endometriosis","enrollment":328},{"nctId":"NCT03070899","phase":"PHASE3","title":"Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"ObsEva SA","startDate":"2017-04-20","conditions":"Uterine Fibroids, Heavy Menstrual Bleeding","enrollment":526},{"nctId":"NCT03070951","phase":"PHASE3","title":"Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"ObsEva SA","startDate":"2017-05-23","conditions":"Uterine Fibroids, Heavy Menstrual Bleeding","enrollment":511},{"nctId":"NCT03961932","phase":"PHASE1","title":"Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function","status":"COMPLETED","sponsor":"ObsEva SA","startDate":"2019-05-15","conditions":"Renal Impairment, Healthy Participants","enrollment":33},{"nctId":"NCT03962049","phase":"PHASE1","title":"Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function","status":"COMPLETED","sponsor":"ObsEva SA","startDate":"2019-05-15","conditions":"Hepatic Impairment, Healthy Participants","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"OBE2109","genericName":"OBE2109","companyName":"ObsEva SA","companyId":"obseva-sa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OBE2109 is a selective progesterone receptor modulator that modulates progesterone signaling to treat reproductive and gynecological disorders. Used for Uterine fibroids (heavy menstrual bleeding), Endometriosis-associated pain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}