According to Rein Therapeutics, the FDA has granted the company’s LTI-03 inhaled dry powder synthetic peptide Fast Track designation for the treatment of idiopathic pulmonary fibrosis. The company notes that the FDA previously granted orphan drug designation to the DPI, and LTI-03 received orphan drug designation from the EMA in January 2026.
In May 2025, Rein announced the initiation of the Phase 2 RENEW trial of LTI-03 in IPF patients, and the FDA placed a clinical hold on the trial soon afterwards. The company announced in November 2025 that the hold had been lifted, and the study was re-started earlier this year.
Rein President and CEO Brian Windsor commented, “Receiving Fast Track designation for LTI-03 from the FDA marks a significant milestone for Rein and underscores the urgent need for new treatment options that can not only halt disease progression but also potentially support tissue repair and regeneration. With our Phase 2 RENEW trial well underway across five countries, we have a unique opportunity to work closely with the FDA to potentially accelerate the development and review of LTI-03. We remain on track to achieve our near-term clinical milestones and anticipate reporting interim data from this trial in the second half of this year.”
Read the Rein Therapeutics press release
