About Us

NephroGenex is an innovator in the development of drugs to treat kidney disease, with a first indication in diabetic nephropathy. We have been pioneering the development of PYRIDORIN® (pyridoxamine dihydrochloride), a late stage compound to treat diabetic patients with this slow-developing but potentially deadly disease. Pyridorin has the potential to slow or stabilize the progression to end-stage renal disease by inhibiting the formation of advanced glycation end products that have been implicated in the development of diabetic nephropathy.

Our clinical and regulatory teams have positioned the Phase 3 PIONEER program for success by securing from the FDA a Fast Track designation and Special Protocol Assessment (SPA) with a new endpoint of a 50% change in serum creatinine or ESRD that will reduce the time, cost and risk of the trials. A SPA is a binding agreement that the protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval. A Fast Track Designation by the FDA is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

We believe Pyridorin represents real hope for the millions of type 2 diabetic patients around the world who have diabetic nephropathy.