Pharmaceutical Business review

FDA approves NephroGenex’s IND application for clinical study of intravenous Pyridorin to treat acute kidney injury

Acute kidney injury (AKI) is a serious medical condition characterized by an abrupt loss of kidney function. AKI is estimated to affect up to 18 percent of hospital inpatients and is responsible for approximately 2 million deaths annually worldwide.

In Company sponsored preclinical studies, I.V. Pyridorin ameliorated renal oxidative stress and injury, enhanced functional recovery and reduced post-injury fibrosis. Additionally, a recently completed preclinical toxicity study of intravenous Pyridorin did not show signs of toxicity or intolerance to the drug.

NephroGenex chief medical officer Jaikrishna Patel said: "The clearance of our IND application for I.V. Pyridorin represents a significant milestone for our AKI program.

"We look forward to further investigating intravenous Pyridorin, which we believe has the potential to be an important treatment option for patients suffering from hospital-acquired AKI."

About Acute Kidney Injury

Acute kidney injury (AKI) is a serious medical condition and significant cause of morbidity, extended hospitalizations and increased medical costs.

AKI is characterized by an abrupt loss of kidney function that usually develops within a few hours to a few days, and occurs when the kidneys suddenly become unable to filter water and waste products from the body.

AKI is most common in patients who have been hospitalized for other critical conditions or in patients who require surgery. Major causes of hospital-acquired AKI include decreased renal perfusion during surgery, contrast nephropathy and cancer therapy with nephrotoxic drugs such as cisplatin.