No approved treatment for this lung disease cough. A new pill now heads into Phase 3 trials

Trevi Therapeutics announced the completion of its End-of-Phase 2 meeting with the FDA, gaining alignment for its development program for Haduvio (nalbuphine ER oral) to treat idiopathic pulmonary fibrosis (IPF)-related chronic cough. The company plans to conduct two pivotal Phase 3 trials in parallel, starting in Q2 2026 and H2 2026, alongside remaining Phase 1 studies to support a New Drug Application (NDA). These trials will evaluate a 54 mg BID dose, using 24-hour cough frequency as the primary endpoint.