{"id":"pgl4001-matching-placebo-and-iron","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Vaginal bleeding"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PGL4001 (dydrogesterone) binds to progesterone receptors in the endometrium and myometrium, enhancing endometrial receptivity and reducing uterine contractility. This mechanism supports early pregnancy maintenance by stabilizing the endometrial environment and reducing the risk of spontaneous abortion in women with recurrent miscarriage or threatened abortion.","oneSentence":"PGL4001 is a selective progesterone receptor agonist that promotes endometrial decidualization and suppresses uterine contractions to prevent miscarriage.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:51:16.421Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of recurrent miscarriage in women with progesterone deficiency"},{"name":"Treatment of threatened abortion"}]},"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":["Placebo of ulipristal"],"phase":"phase_3","status":"active","brandName":"PGL4001 matching placebo and iron","genericName":"PGL4001 matching placebo and iron","companyName":"PregLem SA","companyId":"preglem-sa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PGL4001 is a selective progesterone receptor agonist that promotes endometrial decidualization and suppresses uterine contractions to prevent miscarriage. Used for Prevention of recurrent miscarriage in women with progesterone deficiency, Treatment of threatened abortion.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}