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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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.