{"id":"pgl4001-placebo-drug-free-period","safety":{"commonSideEffects":[{"rate":null,"effect":"Vaginal irritation or discharge"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PGL4001 (neuropeptide Y analog or progesterone receptor modulator) acts on progesterone receptors in the myometrium to suppress uterine contractions and maintain pregnancy. By enhancing the inhibitory signals that prevent premature labor, it reduces the risk of preterm birth in at-risk pregnancies. The drug is designed to be administered as a vaginal insert for sustained local and systemic progesterone activity.","oneSentence":"PGL4001 is a selective progesterone receptor agonist that promotes uterine quiescence and prevents preterm labor.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:29.019Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of preterm birth in women at risk for spontaneous preterm labor"}]},"trialDetails":[{"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}],"_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, placebo, drug free period","genericName":"PGL4001, placebo, drug free period","companyName":"PregLem SA","companyId":"preglem-sa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PGL4001 is a selective progesterone receptor agonist that promotes uterine quiescence and prevents preterm labor. Used for Prevention of preterm birth in women at risk for spontaneous preterm labor.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}