{"id":"n-acetylcysteine-amide","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Gastrointestinal disturbance"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"NACA is a modified form of N-acetylcysteine that crosses cell membranes more efficiently to increase intracellular glutathione levels. By boosting cellular antioxidant defenses, it reduces reactive oxygen species (ROS) and oxidative damage. This mechanism is particularly relevant for retinal and ocular conditions where oxidative stress contributes to cell death and degeneration.","oneSentence":"N-Acetylcysteine Amide (NACA) acts as a free radical scavenger and antioxidant that replenishes intracellular glutathione to protect cells from oxidative stress.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:22:29.154Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry age-related macular degeneration (AMD)"},{"name":"Retinal dystrophies and inherited retinal diseases"}]},"trialDetails":[{"nctId":"NCT07301294","phase":"PHASE4","title":"Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.","status":"NOT_YET_RECRUITING","sponsor":"Menoufia University","startDate":"2026-01-01","conditions":"Double J Stent","enrollment":100},{"nctId":"NCT07290530","phase":"PHASE3","title":"24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome","status":"NOT_YET_RECRUITING","sponsor":"Nacuity Pharmaceuticals, Inc.","startDate":"2026-06","conditions":"Retinitis Pigmentosa (RP), Usher Syndrome","enrollment":80},{"nctId":"NCT05994534","phase":"PHASE1, PHASE2","title":"PK and PD Study of NPI-001 and Cysteamine Bitartrate","status":"RECRUITING","sponsor":"Nacuity Pharmaceuticals, Inc.","startDate":"2023-10-29","conditions":"Cystinosis","enrollment":12},{"nctId":"NCT00585559","phase":"PHASE3","title":"Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm","status":"TERMINATED","sponsor":"Vanderbilt University Medical Center","startDate":"2007-04","conditions":"Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm","enrollment":44},{"nctId":"NCT06105060","phase":"EARLY_PHASE1","title":"Clinical Effects of New Approach on Patients With Non-alcoholic Steatohepatitis","status":"COMPLETED","sponsor":"Beni-Suef University","startDate":"2023-12-17","conditions":"Non-alcoholic Steatohepatitis","enrollment":175},{"nctId":"NCT01209455","phase":"NA","title":"Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2011-01-03","conditions":"Poisoning","enrollment":24},{"nctId":"NCT04015557","phase":"PHASE1, PHASE2","title":"Effect of Acetaminophen and N-Acetylcysteine on Liver Metabolism on Homocystinuria","status":"SUSPENDED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2022-02-11","conditions":"CBS Deficiency","enrollment":10},{"nctId":"NCT01322009","phase":"PHASE1, PHASE2","title":"Overcoming Membrane Transporters to Improve CNS Drug Delivery - Improving Brain Antioxidants After Traumatic Brain Injury","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2011-03","conditions":"Pediatric Traumatic Brain Injury","enrollment":14},{"nctId":"NCT02206178","phase":"PHASE1","title":"Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine","status":"COMPLETED","sponsor":"University Hospital, Clermont-Ferrand","startDate":"2013-09","conditions":"Healthy","enrollment":24},{"nctId":"NCT01137591","phase":"NA","title":"Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever","status":"WITHDRAWN","sponsor":"Columbia University","startDate":"2009-04","conditions":"Liver Failure, Liver Failure, Acute, Drug Induced Liver Injury","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":100,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["NPI-001"],"phase":"phase_3","status":"active","brandName":"N-Acetylcysteine Amide","genericName":"N-Acetylcysteine Amide","companyName":"Nacuity Pharmaceuticals, Inc.","companyId":"nacuity-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"N-Acetylcysteine Amide, also known as NPI-001, is being studied in clinical trials for conditions such as Retinitis Pigmentosa, Usher Syndrome, and CBS Deficiency. It is being tested as a potential treatment in a 24-month trial for the preservation of photoreceptors in Retinitis Pigmentosa associated with Usher Syndrome.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}