choline chloride (IV choline chloride for IFALD) / Protara Therap - LARVOL DELTA

Protara Therapeutics Announces Encore Presentation of Results from THRIVE-1 Prospective Observational Study Evaluating the Prevalence of Choline Deficiency and Liver Injury in Patients Dependent on Parenteral Support (GlobeNewswire) - P=Obs | N=80 | THRIVE-1 (NCT05011370) | Sponsor: Protara Therapeutics | "Protara Therapeutics, Inc...today announced that data from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS), will be featured during an oral session at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2025 Nutrition Science & Practice Conference...Results demonstrated that 78% of patients who are dependent on PS were choline deficient, and that 63% of choline deficient participants had liver dysfunction, including steatosis, cholestasis, and hepatobiliary injury, underscoring the need for IV choline replacement therapy in this patient population...The Company plans to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the first half of 2025."

New P2/3 trial • Observational data • Gastrointestinal Disorder

Protara Therapeutics Granted FDA Fast Track Designation for Intravenous Choline Chloride for Patients Receiving Parenteral Support (GlobeNewswire) - "Protara Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Intravenous (IV) Choline Chloride, the Company’s investigational IV phospholipid substrate replacement therapy, as a source of choline for adult and adolescent patients on parenteral support (PS) for whom oral or enteral nutrition is not possible, insufficient, or contraindicated. In the U.S. alone, there are approximately 40,000 patients on long-term parenteral support."

Fast track • Gastrointestinal Disorder