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# Tvardi Therapeutics Orphan Status for Pulmonary Fibrosis Drug
- URL: https://www.fdaweb.com/tvardi-therapeutics-orphan-status-for-pulmonary-fibrosis-drug/
- Published: 2022-05-26T12:00:00.000Z
- Updated: 2026-09-14T17:46:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151915

FDA has granted Tvardi Therapeutics an orphan drug designation for TTI-101 for treating idiopathic pulmonary fibrosis (IPF). TTI-101 is described as an orally-delivered, small molecule, direct STAT3 inhibitor. “STAT3 has emerged as a central node of fibrosis and has been found to accumulate in the fibrotic lungs of IPF patients,” the company says. “STAT3 plays a major role in many of the cellular processes that drive the development and progression of fibrosis including clotting and coagulation, inflammatory cell migration, fibroblast proliferation, and extra-cellular matrix deposition.”  
  
The therapy is currently being evaluated in a Phase 1 single agent multicenter clinical trial in patients with advanced solid tumors. The study has shown that TTI-101 is well tolerated and has clinical activity across a broad range of tumors, Tvardi says, adding that pre-clinical studies have also demonstrated that STAT3 inhibition with TTI-101 reverses fibrosis and restores lung function in IPF models.