{"id":"heme-arginate-normosang","safety":{"commonSideEffects":[{"rate":null,"effect":"Phlebitis or injection site reactions"},{"rate":null,"effect":"Transient fever"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"In acute intermittent porphyria and other acute porphyrias, overproduction of toxic porphyrin precursors (ALA and PBG) causes severe neurovisceral symptoms. Heme arginate provides exogenous heme, which suppresses ALAS1 activity through negative feedback, thereby reducing precursor synthesis and alleviating acute attack symptoms. This mechanism addresses the underlying biochemical defect rather than treating symptoms alone.","oneSentence":"Heme arginate replenishes depleted heme pools and inhibits delta-aminolevulinic acid synthase (ALAS1) to reduce the toxic accumulation of porphyrin precursors in acute porphyria attacks.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:15:03.148Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute intermittent porphyria (acute attack)"},{"name":"Variegate porphyria (acute attack)"},{"name":"Hereditary coproporphyria (acute attack)"}]},"trialDetails":[{"nctId":"NCT03646344","phase":"PHASE3","title":"Heme Arginate in Transplantation Study","status":"TERMINATED","sponsor":"University of Edinburgh","startDate":"2019-03-12","conditions":"Renal Transplant Rejection, Renal Transplant Failure","enrollment":47},{"nctId":"NCT02142699","phase":"PHASE2","title":"Heme Arginate in Cardiac Surgery Patients","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2014-10-17","conditions":"Acute Kidney Injury","enrollment":20},{"nctId":"NCT02949830","phase":"PHASE1, PHASE2","title":"A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)","status":"COMPLETED","sponsor":"Alnylam Pharmaceuticals","startDate":"2016-10","conditions":"Acute Intermittent Porphyria","enrollment":16},{"nctId":"NCT01855841","phase":"PHASE2","title":"Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis","status":"COMPLETED","sponsor":"Erasme University Hospital","startDate":"2012-04","conditions":"Post-ERCP Acute Pancreatitis","enrollment":284},{"nctId":"NCT02314780","phase":"PHASE2","title":"The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart","status":"COMPLETED","sponsor":"Martin Andreas, M.D.","startDate":"2015-03-29","conditions":"Myocardial Ischemia","enrollment":31},{"nctId":"NCT01430156","phase":"PHASE3","title":"Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2012-01","conditions":"Graft Failure, Ischemia-reperfusion Injury","enrollment":40},{"nctId":"NCT00682370","phase":"PHASE1","title":"Effects of Heme Arginate in Healthy Male Subjects","status":"COMPLETED","sponsor":"Daniel Doberer","startDate":"2007-10","conditions":"Healthy Subjects, Heme Oxygenase, Genetic Polymorphism","enrollment":15},{"nctId":"NCT01461512","phase":"PHASE2","title":"Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)","status":"UNKNOWN","sponsor":"MWolzt","startDate":"2009-01","conditions":"Ischemia-reperfusion Injury","enrollment":16},{"nctId":"NCT00856817","phase":"PHASE4","title":"Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation","status":"TERMINATED","sponsor":"Radboud University Medical Center","startDate":"2009-03","conditions":"Atherosclerotic Cardiovascular Disease","enrollment":6},{"nctId":"NCT00483587","phase":"PHASE1, PHASE2","title":"Does Heme Oxygenase-1 Induction Ameliorate Cardiac Injury After Myocardial Infarction?","status":"COMPLETED","sponsor":"University Medical Center Groningen","startDate":"2007-07","conditions":"Acute Myocardial Infarction","enrollment":15},{"nctId":"NCT00004789","phase":"PHASE1, PHASE2","title":"Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria","status":"COMPLETED","sponsor":"National Center for Research Resources (NCRR)","startDate":"1993-07","conditions":"Porphyria","enrollment":59},{"nctId":"NCT00004396","phase":"PHASE2","title":"Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias","status":"COMPLETED","sponsor":"National Center for Research Resources (NCRR)","startDate":"1997-09","conditions":"Porphyria","enrollment":32},{"nctId":"NCT00004397","phase":"PHASE1","title":"Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria","status":"COMPLETED","sponsor":"National Center for Research Resources (NCRR)","startDate":"1998-01","conditions":"Porphyria","enrollment":20},{"nctId":"NCT00004398","phase":"PHASE1","title":"Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria","status":"COMPLETED","sponsor":"National Center for Research Resources (NCRR)","startDate":"1998-01","conditions":"Porphyria","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Heme Arginate","Hemin"],"phase":"phase_3","status":"active","brandName":"Heme arginate (Normosang)","genericName":"Heme arginate (Normosang)","companyName":"University of Edinburgh","companyId":"university-of-edinburgh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Heme arginate replenishes depleted heme pools and inhibits delta-aminolevulinic acid synthase (ALAS1) to reduce the toxic accumulation of porphyrin precursors in acute porphyria attacks. Used for Acute intermittent porphyria (acute attack), Variegate porphyria (acute attack), Hereditary coproporphyria (acute attack).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}