{"id":"lcr-regenerans","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Abdominal discomfort"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":{"chemblId":"CHEMBL5185225","moleculeType":null,"molecularWeight":"633.66"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug consists of a defined consortium of beneficial bacterial strains intended to restore dysbiotic microbiota to a healthy state. By recolonizing the intestinal tract with specific probiotic organisms, it aims to restore microbial diversity and function, thereby improving barrier integrity and reducing pathogenic overgrowth. This microbiota restoration may have downstream effects on immune homeostasis and intestinal health.","oneSentence":"Lcr Regenerans is a live biotherapeutic product designed to restore and regenerate the gut microbiota composition.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:18:23.571Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Microbiota restoration in dysbiosis-related conditions (specific indication under investigation in Phase 3)"}]},"trialDetails":[{"nctId":"NCT02979288","phase":"PHASE3","title":"Treatment of the Intermediate Vaginal Microbiota With Vaginal Lactobacillus Casei Rhamnosus to Improve Pregnancy Outcome","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2017-05-02","conditions":"Lactobacillus Infection","enrollment":120},{"nctId":"NCT02730494","phase":"PHASE1","title":"Study Evaluating the Optimal Dosage for Equivalence Between Lcr Regenerans® Capsules and Tablets (Lactobacillus Rhamnosus Lcr35®) on the Vaginal Flora Colonisation","status":"COMPLETED","sponsor":"Biose","startDate":"2015-07","conditions":"Candidiasis, Vulvovaginal","enrollment":34},{"nctId":"NCT02251093","phase":"PHASE3","title":"Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis","status":"COMPLETED","sponsor":"Probionov","startDate":"2014-05","conditions":"Candidiasis, Vulvovaginal","enrollment":350}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["GYNOPHILUS"],"phase":"phase_3","status":"active","brandName":"Lcr Regenerans","genericName":"Lcr Regenerans","companyName":"Probionov","companyId":"probionov","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lcr Regenerans is a live biotherapeutic product designed to restore and regenerate the gut microbiota composition. Used for Microbiota restoration in dysbiosis-related conditions (specific indication under investigation in Phase 3).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}