Rein Therapeutics announced that the EMA has granted orphan drug designation to the company’s LTI-03 inhaled dry powder caveolin-1 scaffolding domain peptide for the treatment of idiopathic pulmonary fibrosis. LTI-03 already has orphan designation from the FDA, the company said.
In May 2025, Rein initiated the Phase 2 RENEW trial of LTI-03 in IPF patients, and the FDA placed a clinical hold on the trial shortly thereafter. In November 2025, the company announced that the agency had lifted the clinical hold. According to the study record, that trial is active but not recruiting.
Rein Therapeutics CEO Brian Windsor commented, “This designation represents an important regulatory milestone for Rein and a meaningful step forward for patients living with IPF. Receiving orphan drug designation in Europe provides external validation of our strategy that can do more than slow disease progression. We believe LTI-03 has the potential to address this unmet need.”
Read the Rein Therapeutics press release
