Protara Therapeutics Announces Fast Track Designation For Intravenous Choline Chloride

(RTTNews) - Protara Therapeutics, Inc. (TARA) announced the FDA has granted Fast Track designation to Intravenous Choline Chloride, the investigational IV phospholipid substrate replacement therapy, as a source of choline for adult and adolescent patients on parenteral support for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.

Jesse Shefferman, Chief Executive Officer of Protara Therapeutics, said: "Looking ahead, we remain on track to initiate our registrational THRIVE-3 clinical trial in the first quarter of 2025."

Based on feedback from the FDA, Protara intends to assess the safety and efficacy of IV Choline Chloride in THRIVE-3, a registrational Phase 2b/3 trial with dose confirmation followed by a double-blinded, randomized, placebo-controlled trial in adolescents and adults receiving parenteral support.

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