Trevi Therapeutics Inc Dossier
Qualitative Analysis
Business overview
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of its sole investigational therapy, Haduvio (oral nalbuphine ER), for neurologically mediated conditions. The company's primary clinical focus is on treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is an oral extended-release formulation of nalbuphine, designed to target both central and peripheral nervous system pathways to reduce the cough reflex. Trevi operates as a single reportable segment dedicated to the development of this therapeutic candidate.
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Following alignment with the FDA during an End-of-Phase 2 meeting, Trevi is initiating a Phase 3 program consisting of two parallel clinical trials (approximately 300 and 130 patients) to evaluate the safety and efficacy of Haduvio (nalbuphine ER) for chronic cough in IPF.
Expected impact: Establish clinical efficacy and safety to support a future New Drug Application (NDA) submission.
Expanding the clinical utility of Haduvio by initiating a Phase 2b trial in RCC and a Phase 2b trial in non-IPF ILD-related chronic cough to target broader patient populations with high unmet medical needs.
Expected impact: Broaden the addressable market and diversify clinical indications for the lead asset.