Trevi reports Q3 2026 results, three chronic cough trials now recruiting

Trevi Therapeutics, Inc. announced financial results for the quarter ended September 30, 2026, along with a set of pipeline updates for its investigational drug Haduvio (oral nalbuphine ER) on November 9, 2026.

The company said it began the 12-week fixed-dose OCEAN-2 trial in the third quarter of 2026, with topline data expected in the second half of 2027¹. Its companion study, the 52-week fixed-dose OCEAN-1 trial, started in the second quarter of 2026, with results anticipated in the first half of 2028¹. Both studies target IPF-related chronic cough and are actively recruiting.

On the non-IPF interstitial lung disease (ILD) front, Trevi said it held a positive meeting with the FDA on its chronic cough program and reached alignment on the development path, including the design of a planned Phase 2 dose-ranging study¹. That trial will test 54 mg and 27 mg twice-daily doses of nalbuphine ER against placebo, measuring relative change in 24-hour cough frequency after 12 weeks of fixed dosing as the primary endpoint¹. Enrollment is planned at approximately 120 patients, with initiation targeted for the first quarter of 2027 pending FDA review of the protocol, and topline results expected in the first half of 2028¹.

Trevi also disclosed a Notice of Allowance from the USPTO covering a patent application for nalbuphine ER dosing in hepatically impaired non-IPF ILD cough patients, which it expects to expire in 2041 once issued¹.

In refractory chronic cough (RCC), the Phase 2b LAKE trial, initiated in the second quarter of 2026, continues to enroll¹, with an interim sample-size re-estimation analysis now expected early in the first quarter of 2027¹ and full trial topline results still expected in the second half of 2027¹.

Financially, Trevi ended the third quarter with $299.4 million in cash, cash equivalents and marketable securities¹, which the company said should fund Haduvio's IPF-related chronic cough development through potential FDA approval, with runway extending into 2030¹. Net loss for the quarter was $21.5 million, compared with $11.8 million in the same period of 2025¹.