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Pivotal program uses new FDA-approvable endpoint The Phase 3 PIONEER program includes two identical double-blind, placebo-controlled Phase 3 trials. Each is designed to evaluate the safety and efficacy of PYRIDORIN® (pyridoxamine dihydrochloride) at 300 mg twice a day compared to placebo in reducing the rate of renal disease progression in Type 2 diabetic patients. PYR-311 is…

Pyridorin well tolerated, with adverse event rates similar to placebo Following several preclinical and Phase 1 studies, four placebo-controlled PYRIDORIN® (pyridoxamine dihydrochloride) Phase 2 trials provided the guidance to support the design of the Phase 3 PIONEER program. This included PYR-206, PYR-205/207, and PYR-210. All four studies suggested a clinical benefit in diabetic nephropathy for patients…

Addressing an unmet medical need to slow disease progression At NephroGenex, we are committed to developing a more effective treatment for diabetic kidney disease—a critical global health issue. We are now in a Phase 3 study with PYRIDORIN® (pyridoxamine dihydrochloride), a novel acting compound to reduce the rate of disease progression in patients with diabetic…

The condition can result in loss of kidney function in just 1-2 days Acute kidney injury (AKI) is characterized by an abrupt loss of kidney function that usually develops within just a few hours to a few days. AKI occurs when the kidneys suddenly become unable to filter water and waste products from the body…

Patients with long-standing diabetes are at high risk for developing renal failure The kidneys are two fist-sized organs located in the back of the abdomen on either side of the spine, directly above the waist. Our kidneys perform several crucial and life-sustaining functions including removing waste and excess fluid and regulating blood pressure. The two…

Studies found slowing of disease progression in target population PYRIDORIN® (pyridoxamine dihydrochloride) is a novel small molecule drug candidate with a chemical structure similar to, but distinct from, vitamin B6 (pyridoxine). Unlike vitamin B6, pyridoxamine is regulated as an investigational drug candidate by the U.S. Food and Drug Administration. The compound has a distinct structure…