{"id":"maat013","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disorders (nausea, diarrhea, abdominal pain)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Infection"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MaaT013 is a rationally-designed, consortium-based microbiota therapeutic derived from a healthy donor's fecal microbiota. It aims to restore microbial diversity and function in patients with dysbiotic conditions, thereby modulating immune responses and reducing inflammation. The drug is designed to address immune-mediated disorders by rebalancing the patient's gut microbiota ecosystem.","oneSentence":"MaaT013 is a microbiota-based therapeutic that restores a healthy gut microbiome composition to treat immune-mediated diseases.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:20:00.169Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Steroid-refractory acute graft-versus-host disease (aGvHD)"}]},"trialDetails":[{"nctId":"NCT04988841","phase":"PHASE2","title":"Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-01-20","conditions":"Melanoma","enrollment":70},{"nctId":"NCT04769895","phase":"PHASE3","title":"MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"MaaT Pharma","startDate":"2022-03-25","conditions":"Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD","enrollment":66},{"nctId":"NCT04768907","phase":"","title":"Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease","status":"AVAILABLE","sponsor":"MaaT Pharma","startDate":"","conditions":"Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD","enrollment":""},{"nctId":"NCT05017688","phase":"NA","title":"Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013","status":"UNKNOWN","sponsor":"MaaT Pharma","startDate":"2021-10-06","conditions":"Intestinal GVHD, Steroid Refractory GVHD","enrollment":40},{"nctId":"NCT03359980","phase":"PHASE2","title":"Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer","status":"COMPLETED","sponsor":"MaaT Pharma","startDate":"2018-08-13","conditions":"Fecal Microbiota Transplantation","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["fecal microbiotherapy"],"phase":"phase_3","status":"active","brandName":"MaaT013","genericName":"MaaT013","companyName":"MaaT Pharma","companyId":"maat-pharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MaaT013 is a microbiota-based therapeutic that restores a healthy gut microbiome composition to treat immune-mediated diseases. Used for Steroid-refractory acute graft-versus-host disease (aGvHD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}