Protara Aligns with FDA on Registrational Path in Parenteral Nutrition

 

• New development pathway significantly expands addressable patient population for IV Choline Chloride
  
• IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.
  
• Approximately 80% of PN patients are choline deficient, which can lead to liver damage and hepatic failure; ASPEN recommends choline replacement for PN patients
  
• Company expects to start registrational trial to support FDA approval of IV Choline Chloride for PN patients in the first half of 2025

https://www.globenewswire.com/news-release/2024/04/05/2858495/0/en/Protara-Therapeutics-Announces-Alignment-with-FDA-on-Registrational-Path-Forward-for-IV-Choline-Chloride-in-Patients-Dependent-on-Parenteral-Nutrition.html