Protara Therapeutics announced that it has dosed the first patient in its Phase 3 THRIVE‑3 trial of IV Choline Chloride on January 7, 2026, a milestone that moves the company from early‑stage development into a full‑scale Phase 3 program.
The THRIVE‑3 study is a seamless Phase 2b/3 design that begins with an 8‑week open‑label dose‑confirmation phase of 24 patients, followed by a 24‑week double‑blind, randomized, placebo‑controlled phase that will enroll approximately 105 additional patients. The primary endpoint is the change in plasma choline concentration from baseline compared with placebo.
IV Choline Chloride targets a critical unmet need for patients who rely on long‑term parenteral nutrition. These patients are at risk of choline deficiency, which can lead to hepatic injury, neuro‑psychological impairment, muscle damage, and thrombotic abnormalities. The drug has received Fast Track designation from the FDA, which can accelerate development and review for therapies that address serious conditions and unmet needs.
Protara’s financial position supports the ongoing trial. As of September 30, 2025, the company held $133.6 million in cash, cash equivalents, and investments, providing a runway into mid‑2027. Two public offerings in December 2024 and December 2025 raised $186 million, extending the cash runway into 2028 and enabling continued investment in the THRIVE‑3 program and other pipeline assets such as TARA‑002.
CEO Jesse Shefferman said the first‑patient dose “provides the first substantive data on safety and efficacy in a real‑world setting” and that a successful THRIVE‑3 outcome could unlock a new revenue stream and create partnership or licensing opportunities with larger specialty‑care providers. He added that the company expects to deliver an interim analysis in the second half of 2026.
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