Protara Therapeutics receives FDA Orphan Drug Designation for IV Choline Chloride to treat choline deficiency in parenteral nutrition patients.
Protara Therapeutics aligns with FDA on a registrational path for IV Choline Chloride, an investigational phospholipid substrate replacement. Previously pursuing IFALD indication, the company will now target patients on parenteral nutrition unable to synthesize choline. FDA grants Orphan Drug Designation for choline deficiency prevention in PN patients. A single study will be conducted to restore choline.
April 05, 2024
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