Clinical Hold Lifted by FDA on Nile’s Cardiac Drug

The FDA has lifted the clinical hold on Nile Therapeutics’ CD-NP treatment for acute heart failure and renal insufficiency. Nile will submit the finalized protocol to the FDA for a planned 30-patient, single-blind, placebo-controlled Phase II clinical trial, according to a statement. The drug is administered in an infusion for as long as 72 hours. The company says it expects to complete the dosing in the study by the end of the year.
Washington Drug Letter