{"id":"pgl4001-ulipristal-and-iron","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Amenorrhea or oligomenorrhea"},{"rate":null,"effect":"Hot flushes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ulipristal acetate acts as a selective progesterone receptor agonist/antagonist, disrupting the luteinizing hormone surge necessary for ovulation and modifying endometrial proliferation. The iron component provides supplemental iron to treat or prevent iron deficiency anemia, which may occur secondary to heavy menstrual bleeding. This combination targets both the hormonal and hematologic aspects of conditions like uterine fibroids.","oneSentence":"Ulipristal is a selective progesterone receptor modulator that suppresses ovulation and alters the endometrium, while iron supplementation addresses iron deficiency anemia.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:30.014Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Uterine fibroids (leiomyomas) with heavy menstrual bleeding"},{"name":"Iron deficiency anemia secondary to heavy menstrual bleeding"}]},"trialDetails":[{"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":0,"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 (ulipristal) and iron","genericName":"PGL4001 (ulipristal) and iron","companyName":"PregLem SA","companyId":"preglem-sa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ulipristal is a selective progesterone receptor modulator that suppresses ovulation and alters the endometrium, while iron supplementation addresses iron deficiency anemia. Used for Uterine fibroids (leiomyomas) with heavy menstrual bleeding, Iron deficiency anemia secondary to heavy menstrual bleeding.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}