Trevi Therapeutics (TRVI)

Executive Summary

Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine ER), a first-in-class kappa agonist/mu antagonist for chronic cough in idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (ILD), and refractory chronic cough. Chronic cough affects up to 10% of adults with no approved therapies, representing a significant unmet need. Haduvio's dual mechanism of action targets cough reflex hypersensitization, with prior Phase 2a data showing promising efficacy and safety. The company recently completed a Phase 2b trial (CORAL) in IPF cough and a drug-drug interaction study with standard-of-care therapies, positioning it for a potential Phase 3 initiation.

Upcoming Catalysts (preview)

• Q2 2026Top-line results from Phase 2 CORAL trial in IPF cough70% success
• H2 2026Initiation of Phase 3 trial in IPF cough80% success
• Q3 2026FDA orphan drug designation for Haduvio in IPF cough60% success