{"id":"pgl4001-progestin","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Breast tenderness"}]},"_chembl":{"chemblId":"CHEMBL103","moleculeType":"Small molecule","molecularWeight":"314.47"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"As a progestin, PGL4001 binds to progesterone receptors in the uterus and endometrium, suppressing myometrial contractions and promoting endometrial changes that support pregnancy maintenance or prevent abnormal uterine bleeding. This mechanism allows it to address conditions where progesterone deficiency or receptor dysfunction contributes to pathology, such as heavy menstrual bleeding or preterm labor prevention.","oneSentence":"PGL4001 is a selective progesterone receptor agonist that mimics the action of the natural hormone progesterone to modulate uterine contractility and endometrial function.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:51:07.014Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Heavy menstrual bleeding"},{"name":"Preterm labor prevention"}]},"trialDetails":[{"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}],"_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, progestin","genericName":"PGL4001, progestin","companyName":"PregLem SA","companyId":"preglem-sa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PGL4001 is a selective progesterone receptor agonist that mimics the action of the natural hormone progesterone to modulate uterine contractility and endometrial function. Used for Heavy menstrual bleeding, Preterm labor prevention.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}