Trevi Therapeutics gains FDA alignment on Phase 3 plan for nalbuphine ER in IPF cough; first trial Q2 2026

Trevi Therapeutics, Inc.

End-of-Phase 2 FDA meeting: overall alignment on IPF-related chronic cough development program including two pivotal Phase 3 trials and Phase 1 studies for NDA support.
First Phase 3 trial (~300 patients, 52-week dosing, primary endpoint at 24 weeks) expected to start Q2 2026; second Phase 3 (~130 patients, 12-week dosing) in H2 2026.
Both trials randomized, double-blind, placebo-controlled, global, evaluating nalbuphine ER 54 mg BID vs placebo with 2:1 randomization.
Primary endpoint for both: relative change from baseline in 24-hour cough frequency measured by objective cough monitor.
Trial designs are subject to final FDA protocol review.

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