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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients With Idiopathic Pulmonary Fibrosis

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Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients With Idiopathic Pulmonary Fibrosis

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Nov 2025

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At a glance

  • Drugs LTI 03 (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Adverse reactions
  • Acronyms RENEW
  • Sponsors Rein Therapeutics

Most Recent Events

  • 03 Nov 2025 According to a Rein Therapeutics media release, initial topline data from the trial is expected in Q3 2026.
  • 03 Nov 2025 According to a Rein Therapeutics media release, the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold on the trial. And, expects to resume patient recruitment in late 2025 or early 2026 across approximately 20 U.S. clinical sites located in Alabama, California, Colorado, Connecticut, Florida, Indiana, Kansas, Massachusetts, Michigan, Missouri, North Carolina, New York, Ohio, South Carolina, and Texas.
  • 09 Oct 2025 According to a Rein Therapeutics media release, company has received authorization from the European Medicines Agency (EMA) based on the sites of Germany and Poland locations.

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