{"id":"aralast-np","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":{"setId":"a9a5b46e-04da-41bd-bb5f-c4936b664fef","title":"ARALAST NP (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Alpha-1 antitrypsin (AAT) is a serine protease inhibitor that protects lung tissue from neutrophil elastase and other proteases released during inflammation. In alpha-1 antitrypsin deficiency, insufficient AAT levels allow unopposed protease activity, leading to progressive lung damage. Aralast NP is an intravenous augmentation therapy that restores circulating AAT levels to therapeutic thresholds, thereby slowing the decline in lung function and reducing emphysema progression.","oneSentence":"Aralast NP is a purified human alpha-1 protease inhibitor (AAT) that replaces deficient or dysfunctional alpha-1 antitrypsin to protect lung tissue from enzymatic degradation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:17:51.199Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Alpha-1 antitrypsin deficiency with emphysema or chronic obstructive pulmonary disease (COPD)"}]},"trialDetails":[{"nctId":"NCT02713997","phase":"PHASE4","title":"Anti-inflammatory Therapy to Improve Outcomes After TPIAT","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2016-12","conditions":"Pancreatitis, Chronic; Diabetes; Transplant","enrollment":43},{"nctId":"NCT05466747","phase":"PHASE4","title":"A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema","status":"WITHDRAWN","sponsor":"Takeda","startDate":"2024-01-01","conditions":"Chronic Obstructive Pulmonary Disease (COPD), Alpha1-Antitrypsin Deficiency","enrollment":""},{"nctId":"NCT02520076","phase":"PHASE1, PHASE2","title":"Aralast NP in Islet Transplant","status":"COMPLETED","sponsor":"University of Alberta","startDate":"2015-08","conditions":"Type 1 Diabetes Mellitus","enrollment":5},{"nctId":"NCT02722304","phase":"PHASE3","title":"Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency","status":"TERMINATED","sponsor":"Baxalta now part of Shire","startDate":"2016-11-02","conditions":"Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency","enrollment":7},{"nctId":"NCT00396006","phase":"PHASE4","title":"Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2006-10-27","conditions":"Alpha 1-Antitrypsin Deficiency","enrollment":21},{"nctId":"NCT04675086","phase":"PHASE3","title":"Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection","status":"WITHDRAWN","sponsor":"Blessing Corporate Services, Inc","startDate":"2021-01","conditions":"Covid19, Pneumonia, Viral","enrollment":""},{"nctId":"NCT04440488","phase":"PHASE4","title":"ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study","status":"WITHDRAWN","sponsor":"Shire","startDate":"2021-03-08","conditions":"Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency","enrollment":""},{"nctId":"NCT02087813","phase":"PHASE1","title":"Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses","status":"WITHDRAWN","sponsor":"Stanford University","startDate":"2014-03","conditions":"Neuromyelitis Optica","enrollment":""},{"nctId":"NCT01183468","phase":"PHASE1","title":"A Research Trial of Aralast in New Onset Diabetes (RETAIN)","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2010-10","conditions":"Diabetes Mellitus, Type 1","enrollment":17},{"nctId":"NCT01319331","phase":"PHASE1","title":"The Effects of Alpha-1 Antitrypsin (AAT) on the Progression of Type 1 Diabetes","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2010-10","conditions":"Diabetes, Type 1 Diabetes","enrollment":12},{"nctId":"NCT01936896","phase":"PHASE1, PHASE2","title":"Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction","status":"COMPLETED","sponsor":"Virginia Commonwealth University","startDate":"2013-12","conditions":"Acute Myocardial Infarction","enrollment":10},{"nctId":"NCT01183455","phase":"PHASE2","title":"A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II","status":"WITHDRAWN","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2010-10","conditions":"Diabetes Mellitus, Type 1","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":117,"reaction":"DEATH"},{"count":103,"reaction":"PNEUMONIA"},{"count":77,"reaction":"DYSPNOEA"},{"count":32,"reaction":"MALAISE"},{"count":31,"reaction":"CHRONIC OBSTRUCTIVE PULMONARY DISEASE"},{"count":28,"reaction":"COUGH"},{"count":27,"reaction":"BRONCHITIS"},{"count":26,"reaction":"HEADACHE"},{"count":25,"reaction":"FATIGUE"},{"count":22,"reaction":"FALL"}],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Alpha 1-Proteinase Inhibitor Human","Alpha,-antitrypsin","AAT","Alpha1-PI","TAK-883"],"phase":"marketed","status":"active","brandName":"Aralast NP","genericName":"Aralast NP","companyName":"National Institute of Allergy and Infectious Diseases (NIAID)","companyId":"national-institute-of-allergy-and-infectious-diseases-niaid","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Aralast NP is a purified human alpha-1 protease inhibitor (AAT) that replaces deficient or dysfunctional alpha-1 antitrypsin to protect lung tissue from enzymatic degradation. Used for Alpha-1 antitrypsin deficiency with emphysema or chronic obstructive pulmonary disease (COPD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}