{"id":"pgl4001","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Amenorrhea"},{"rate":null,"effect":"Hot flushes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PGL4001 (ulipristal acetate) selectively binds to progesterone receptors in the uterus, modulating endometrial and myometrial function. By acting as a progesterone receptor agonist, it reduces abnormal uterine bleeding and suppresses uterine contractions, making it effective for managing heavy menstrual bleeding and potentially other gynecological conditions related to progesterone signaling.","oneSentence":"PGL4001 is a selective progesterone receptor modulator that acts as a progesterone agonist to reduce uterine contractions and bleeding.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:35.430Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Heavy menstrual bleeding"},{"name":"Uterine fibroids (leiomyomas)"}]},"trialDetails":[{"nctId":"NCT07434128","phase":"PHASE2","title":"Mammogram Pretreatment With Ulipristal Acetate","status":"NOT_YET_RECRUITING","sponsor":"OHSU Knight Cancer Institute","startDate":"2026-04-02","conditions":"Mammography Screening, Breast Density","enrollment":26},{"nctId":"NCT01629563","phase":"PHASE3","title":"PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata","status":"COMPLETED","sponsor":"PregLem SA","startDate":"2012-06","conditions":"Uterine Fibroids","enrollment":451},{"nctId":"NCT01156857","phase":"PHASE3","title":"PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata","status":"COMPLETED","sponsor":"PregLem SA","startDate":"2010-07","conditions":"Uterine Fibroids","enrollment":209},{"nctId":"NCT01252069","phase":"PHASE3","title":"PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)","status":"COMPLETED","sponsor":"PregLem SA","startDate":"2011-01","conditions":"Uterine Fibroids","enrollment":132},{"nctId":"NCT01642472","phase":"PHASE3","title":"PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata","status":"COMPLETED","sponsor":"PregLem SA","startDate":"2012-07","conditions":"Uterine Fibroids","enrollment":64},{"nctId":"NCT00740831","phase":"PHASE3","title":"PGL4001 Versus GnRH-agonist in Uterine Myomas","status":"COMPLETED","sponsor":"PregLem SA","startDate":"2008-08","conditions":"Uterine Myomas","enrollment":301},{"nctId":"NCT00755755","phase":"PHASE3","title":"PGL4001 Versus Placebo in Uterine Myomas","status":"COMPLETED","sponsor":"PregLem SA","startDate":"2008-10","conditions":"Uterine Myomas","enrollment":241}],"_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":["Ulipristal acetate"],"phase":"phase_3","status":"active","brandName":"PGL4001","genericName":"PGL4001","companyName":"PregLem SA","companyId":"preglem-sa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PGL4001 is a selective progesterone receptor modulator that acts as a progesterone agonist to reduce uterine contractions and bleeding. Used for Heavy menstrual bleeding, Uterine fibroids (leiomyomas).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}