{"id":"n-acetyl-l-leucine","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"N-Acetyl-L-Leucine is a branched-chain amino acid derivative that acts as a metabolic enhancer, particularly in the mitochondria of vestibular and cerebellar neurons. It increases ATP production and reduces oxidative stress while modulating neuroinflammatory pathways, thereby improving balance, coordination, and vertigo symptoms in patients with central nervous system disorders affecting these regions.","oneSentence":"N-Acetyl-L-Leucine enhances mitochondrial energy metabolism and reduces neuroinflammation to improve vestibular and cerebellar function.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:17.013Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cerebellar ataxia"},{"name":"Vertigo and balance disorders"},{"name":"Spinocerebellar ataxia"}]},"trialDetails":[{"nctId":"NCT07221292","phase":"PHASE3","title":"Pivotal Study of N-acetyl-L-leucine for CACNA1A","status":"NOT_YET_RECRUITING","sponsor":"IntraBio Inc","startDate":"2026-09-01","conditions":"CACNA1A, Spinocerebellar Ataxia Type 6, Episodic Ataxia Type 2","enrollment":60},{"nctId":"NCT03759678","phase":"PHASE2","title":"N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T)","status":"TERMINATED","sponsor":"IntraBio Inc","startDate":"2020-01-08","conditions":"Ataxia Telangiectasia","enrollment":17},{"nctId":"NCT07380165","phase":"","title":"Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)","status":"AVAILABLE","sponsor":"IntraBio Inc","startDate":"","conditions":"Ataxia-Telangiectasia (A-T)","enrollment":""},{"nctId":"NCT04784234","phase":"NA","title":"Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin","status":"TERMINATED","sponsor":"Wills Eye","startDate":"2021-02-01","conditions":"Primary Open Angle Glaucoma","enrollment":12},{"nctId":"NCT06673056","phase":"PHASE3","title":"A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)","status":"ACTIVE_NOT_RECRUITING","sponsor":"IntraBio Inc","startDate":"2025-03-18","conditions":"Ataxia-Telangiectasia, Ataxia-Telangiectasia (A-T)","enrollment":60},{"nctId":"NCT05163288","phase":"PHASE3","title":"A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C","status":"RECRUITING","sponsor":"IntraBio Inc","startDate":"2022-06-30","conditions":"Niemann-Pick Disease, Type C","enrollment":53},{"nctId":"NCT03759665","phase":"PHASE2","title":"N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)","status":"COMPLETED","sponsor":"IntraBio Inc","startDate":"2019-06-07","conditions":"GM2 Gangliosidosis, Tay-Sachs Disease, Sandhoff Disease","enrollment":30},{"nctId":"NCT03759639","phase":"PHASE2","title":"N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC)","status":"COMPLETED","sponsor":"IntraBio Inc","startDate":"2019-09-04","conditions":"Niemann-Pick Disease, Type C","enrollment":33},{"nctId":"NCT01885338","phase":"PHASE1","title":"N-acetylcysteine (NAC) for Improving Cognitive Dysfunction in Schizophrenia","status":"COMPLETED","sponsor":"VA Greater Los Angeles Healthcare System","startDate":"2013-06","conditions":"Schizophrenia","enrollment":26}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":66,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["IB1001","levacetylleucine"],"phase":"phase_3","status":"active","brandName":"N-Acetyl-L-Leucine","genericName":"N-Acetyl-L-Leucine","companyName":"IntraBio Inc","companyId":"intrabio-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"N-Acetyl-L-Leucine enhances mitochondrial energy metabolism and reduces neuroinflammation to improve vestibular and cerebellar function. Used for Cerebellar ataxia, Vertigo and balance disorders, Spinocerebellar ataxia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}