IV choline chloride - (THRIVE-3)

October 15, 2026: Protara Therapeutics, Inc. (NASDAQ: TARA) announced completion of enrollment in the Phase 2b open-label dose-confirmation portion of the registrational THRIVE-3 trial (NCT06910943) evaluating IV Choline Chloride in adolescent and adult intestinal failure patients who are dependent on parenteral support and have choline deficiency. The Phase 2b cohort includes 24 patients, and the company said it remains on track to report interim results in 4Q 2026.

THRIVE-3 is a seamless Phase 2b/3 study. The Phase 2b portion is assessing safety and pharmacokinetics across multiple doses to select dose(s) for further study. The Phase 3 portion is planned as a randomized, double-blind, placebo-controlled trial of about 100 patients to evaluate efficacy and safety. The primary endpoint is change in plasma choline concentration from baseline to week 8; secondary endpoints include steatosis and liver function tests.

IV Choline Chloride is an investigational therapy for patients on parenteral support and has FDA Orphan Drug designation for prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition, and Fast Track designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated.