Trevi Therapeutics is a clinical-stage biopharmaceutical company with a single drug candidate, Haduvio (oral nalbuphine ER), targeting chronic cough — a condition with no FDA-approved therapies in any of Trevi's target indications. Nalbuphine, the active ingredient, has been available as an injectable pain treatment for decades; Trevi developed an oral extended-release formulation that acts as both a kappa-opioid receptor agonist and mu-opioid receptor antagonist, suppressing the cough reflex centrally and peripherally. Trevi is pursuing three indications: IPF-related chronic cough (its lead program, targeting roughly 100,000 U.S. patients), non-IPF ILD-related chronic cough (~115,000–140,000 U.S. patients), and refractory chronic cough (2–3M U.S. adults). Trevi's lead Phase 2b trial (CORAL) met its primary endpoint in June 2025, showing statistically significant reductions in cough frequency across all doses tested. Following an End-of-Phase 2 FDA meeting, Trevi is planning two parallel Phase 3 trials in IPF, both targeting initiation in 2026. Phase 2b trials in non-IPF ILD and RCC are also planned for 2026. Trevi plans to self-commercialize in the U.S. using a focused specialty sales force targeting pulmonologists, and to use partners outside the U.S. The company is pre-revenue, with roughly $195M in cash as of Q3 2025, which management expects provides runway into 2028.