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# Tvardi’s Lung Disease Drug Falls Short in Trial
- URL: https://www.fdaweb.com/tvardis-lung-disease-drug-falls-short-in-trial/
- Published: 2025-10-13T12:00:00.000Z
- Updated: 2026-09-14T15:24:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160027

Tvardi Therapeutics is reporting that its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary fibrosis, a progressive and fatal lung disease. The company said the trial did not meet its endpoints and variability in the data limited interpretation of the results.

The REVERT trial evaluated oral TTI-101 alone or in combination with nintedanib (Boehringer Ingelheim’s Ofev) in 88 patients with IPF, according to the company. The trial evaluated safety, pharmacokinetics, and forced vital capacity (FVC) — a standard measure of lung capacity.

After analyzing preliminary safety and efficacy data, Tvardi says TTI-101 did not demonstrate improvement over placebo. From baseline to the end of treatment, 41% of placebo patients showed FVC improvement, compared with 39% and 44% of those receiving 400 mg and 800 mg of TTI-101, respectively. Mean change in FVC at 12 weeks was –22 mL for placebo, –61 mL for the 400 mg dose, and –103 mL for the 800 mg dose — differences that were not statistically significant, according to the company.

The company also notes high discontinuation rates in the treatment arms — 56.7% for the 400 mg group and 62.1% for the 800 mg group — primarily due to gastrointestinal side effects, especially among patients also taking nintedanib. By contrast, only 10.3% of placebo patients discontinued treatment.

Tvardi says it is conducting further analyses to understand the results and guide its next steps.