Trevi Therapeutics Outlines Key Development Milestones for Lead Drug Candidate

Trevi Therapeutics has provided investors with a definitive timeline for the advancement of Haduvio (oral nalbuphine ER), its lead therapeutic candidate. The company confirmed it will hold a critical End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026. Following this regulatory discussion, Trevi intends to initiate a Phase 3 clinical trial for chronic cough associated with idiopathic pulmonary fibrosis (IPF) in the first half of that same year. The path to potential approval hinges on the outcome of the FDA consultation and the final design of the upcoming pivotal study.

The announced EOP2 meeting represents a major regulatory milestone on the path toward a potential New Drug Application (NDA). Trevi aims to align with the FDA on the clinical program strategy for Haduvio in IPF-related chronic cough. The subsequent launch of a landmark Phase 3 study is planned to follow directly.

Concurrently, the company is preparing to start a Phase 2b study for refractory chronic cough (RCC), also slated for the first half of 2026.

In a separate corporate development, Trevi announced a change in its financial leadership. David Hastings assumed the role of Chief Financial Officer on January 6. He is scheduled to make his first public appearance alongside senior management at the LifeSci Partners Corporate Access Event in San Francisco next week.

Clinical Promise and Market Context

Trevi’s shares traded at $11.71, a level that reflects an increase of approximately 190% over the past twelve months. This substantial equity appreciation is supported by clinical data from multiple studies where Haduvio demonstrated statistically significant reductions in cough frequency—a result that competing development programs have, in some cases, failed to achieve.

Should investors sell immediately? Or is it worth buying Trevi Therapeutics?

The significant unmet medical need is a central factor in the drug's potential valuation. An estimated 150,000 patients in the U.S. suffer from IPF. Industry reports suggest around two-thirds of these individuals experience uncontrolled chronic cough, a debilitating condition that can accelerate disease progression or necessitate a lung transplant. Haduvio’s mechanism is designed to modulate the cough reflex pathway through both central and peripheral actions. The therapeutic area has seen several high-profile late-stage failures from other developers in recent years.

Analyst sentiment remains constructive following the update. D. Boral Capital reaffirmed its rating on the stock this morning. In total, twelve major brokerage firms continue to carry an "Outperform" recommendation on Trevi. The company reports a cash runway, based on current projections, that extends into 2028.

Upcoming Catalysts and Long-Term Path

In the near term, market attention will focus on Trevi’s participation at the LifeSci Partners Corporate Access Event from January 12–14. Management is expected to provide further details on the Phase 3 trial design and the objectives for the RCC Phase 2b study.

The primary determinant for the program's future will be the FDA’s feedback during the EOP2 meeting in Q1 2026. This guidance will finalize the Phase 3 study protocol and critically shape the regulatory pathway forward. The company’s next major financial update is anticipated in mid-March 2026.

Key Upcoming Milestones:
- FDA End-of-Phase 2 Meeting: Q1 2026
- Phase 3 Trial Initiation (IPF chronic cough): First Half 2026
- Phase 2b Trial Initiation (RCC): First Half 2026