NephroGenex is a drug-development company focusing on kidney disease.
The Company is developing Pyridorin™ (pyridoxamine dihydrochloride) as a treatment to slow the progression of diabetic kidney disease.
Pyridorin™ has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in three Phase 2 clinical trials, and it has been awarded Fast Track status by the FDA. Pyridorin™ is one of the leading drug candidates in advanced clinical trials for diabetic kidney disease.
NephroGenex has reached an agreement with the FDA on a new Phase 3 program that provides for an accelerated regulatory pathway for Pyridorin approval.
"Chronic kidney disease (CKD) represents an enormous burden on the health care system of the U.S. with treatment costs exceeding $24 billion"
(U.S. Renal Data System. USRDS 2005 Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive Kidney Disease: Bethesda, MD, 2005)