{"id":"ultra-micronized-palmitoylethanolamide","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Generally well-tolerated with minimal adverse events"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Palmitoylethanolamide is an endocannabinoid-like compound that reduces neuroinflammation by activating peroxisome proliferator-activated receptor alpha (PPAR-α) and stabilizing mast cells, thereby decreasing the release of pro-inflammatory mediators. The ultra-micronized formulation enhances bioavailability and absorption compared to standard formulations. This mechanism makes it effective for neuropathic pain and inflammatory conditions.","oneSentence":"Ultra-micronized palmitoylethanolamide (um-PEA) is an endogenous lipid mediator that modulates inflammatory and neuropathic pain pathways through PPAR-α activation and mast cell stabilization.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:37:03.694Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Neuropathic pain"},{"name":"Chronic pain conditions"},{"name":"Neuroinflammatory disorders"}]},"trialDetails":[{"nctId":"NCT06790407","phase":"","title":"Observational Metabolic Health Study","status":"COMPLETED","sponsor":"Mimio Health, Inc.","startDate":"2024-08-26","conditions":"Healthy","enrollment":96},{"nctId":"NCT06037993","phase":"NA","title":"Endocannabinoid Activity Remodulation for Psychosis Liability in Youth","status":"UNKNOWN","sponsor":"University of Udine","startDate":"2022-11-01","conditions":"Clinical High Risk for Psychosis, Ultra High Risk for Psychosis, Attenuated Psychotic Symptoms","enrollment":20},{"nctId":"NCT04488926","phase":"PHASE4","title":"Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients","status":"COMPLETED","sponsor":"Epitech Group SpA","startDate":"2020-07-16","conditions":"Fibromyalgia","enrollment":21},{"nctId":"NCT04568876","phase":"PHASE4","title":"Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients","status":"COMPLETED","sponsor":"Epitech Group SpA","startDate":"2020-10-23","conditions":"Covid19","enrollment":40},{"nctId":"NCT02699281","phase":"PHASE4","title":"Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain","status":"COMPLETED","sponsor":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","startDate":"2015-10","conditions":"Chronic Pain","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["um-PEA","Normast"],"phase":"marketed","status":"active","brandName":"ultra-micronized palmitoylethanolamide","genericName":"ultra-micronized palmitoylethanolamide","companyName":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","companyId":"fondazione-irccs-ca-granda-ospedale-maggiore-policlinico","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ultra-micronized palmitoylethanolamide (um-PEA) is an endogenous lipid mediator that modulates inflammatory and neuropathic pain pathways through PPAR-α activation and mast cell stabilization. Used for Neuropathic pain, Chronic pain conditions, Neuroinflammatory disorders.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}