Trevi Therapeutics (TRVI)

Executive Summary

Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio (oral nalbuphine ER), a first-in-class kappa agonist/mu antagonist (KAMA) for chronic cough in idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough (RCC). There are no approved therapies for chronic cough, which affects up to 10% of adults, representing a significant unmet need. Trevi recently completed a Phase 2 trial (NCT05964335) evaluating Haduvio in IPF cough, with top-line data expected to support advancement to pivotal trials. The company also completed a Phase 1 drug-drug interaction study with pirfenidone and nintedanib (NCT07015398), indicating potential for use with standard IPF therapies. With a current market cap of ~$2 billion, Trevi is positioned to address a large market if efficacy and safety are confirmed. Key upcoming catalysts include the presentation of Phase 2 IPF cough data at a major medical conference, initiation of a Phase 3 program for chronic cough, and potential regulatory feedback on the registration pathway.

Upcoming Catalysts (preview)

• Q2 2026Presentation of Phase 2 IPF Cough Top-Line Results (NCT05964335) at Medical Conference80% success
• H2 2026Initiation of Phase 3 Pivotal Trial for Chronic Cough in IPF or Refractory Chronic Cough70% success
• H1 2026FDA Meeting or Written Guidance on Registration Pathway for Haduvio60% success