> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clinical Hold on Pulmonary Fibrosis Drug
- URL: https://www.fdaweb.com/fda-clinical-hold-on-pulmonary-fibrosis-drug/
- Published: 2025-06-13T12:00:00.000Z
- Updated: 2026-09-14T15:14:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159356

FDA has placed a clinical hold on a Rein Therapeutics Phase 2 (RENEW) trial of LTI-03 to request additional non-clinical information. The company says LTI-03 is a novel, multi-pathway Caveolin-1-related peptide being developed for treating patients with idiopathic pulmonary fibrosis (IPF). “Importantly, to date no drug-related serious adverse events have been reported in any studies treating patients with LTI-03,” it adds.

Rein says it previously announced positive topline data from the Phase 1b clinical trial evaluating the safety and tolerability of LTI-03 in patients with IPF, and no safety signals were observed. “LTI-03 was generally well-tolerated, and there were no drug-related adverse events that resulted in a discontinuation of the trial,” it says.