Trevi Therapeutics, Inc. reported financial results for the quarter ended September 30, 2026, and provided updates on its clinical development programs for Haduvio (oral nalbuphine ER). The company announced the initiation of its Phase 3 OCEAN-2 trial in the third quarter of 2026, which is a 12-week fixed-dose study for patients with idiopathic pulmonary fibrosis (IPF)-related chronic cough. Topline results from OCEAN-2 are expected in the second half of 2027.

In addition to OCEAN-2, the company is actively recruiting patients in both Phase 3 OCEAN trials. The OCEAN-1 trial, a 52-week study initiated in the second quarter of 2026, is also ongoing, with topline results expected in the first half of 2028.

Trevi Therapeutics also reported a positive meeting with the FDA regarding its non-IPF interstitial lung disease (non-IPF ILD) chronic cough program. The company expects to initiate a Phase 2 dose-ranging trial in the first quarter of 2027. This trial will evaluate two doses of nalbuphine ER—54 mg twice daily and 27 mg twice daily—versus placebo, with the primary endpoint being the relative change from baseline in 24-hour cough frequency at 12 weeks. The trial is expected to enroll approximately 120 patients.

Regarding intellectual property, the company received a Notice of Allowance from the USPTO for a patent covering dosing nalbuphine ER in hepatically impaired patients with non-IPF ILD-related chronic cough. Once issued, the patent is expected to expire in 2041.

Financially, the company ended the third quarter of 2026 with $299.4 million in cash, cash equivalents, and marketable securities. Trevi stated that this cash balance will provide a runway into 2030 and fund the development of Haduvio for IPF-related chronic cough through potential FDA approval, as well as the Phase 2 program for non-IPF ILD-related chronic cough and the ongoing Phase 2b LAKE trial for refractory chronic cough.

For the third quarter of 2026, the company reported a net loss of $21.5 million, compared to a net loss of $11.8 million in the same period in 2025. Research and development expenses increased to $19.1 million from $10.1 million in the prior year, driven by increased clinical development expenses associated with the Phase 3 OCEAN-1 and OCEAN-2 trials and the Phase 2b LAKE trial. General and administrative expenses increased to $5.4 million from $3.8 million in the prior year, primarily due to stock-based compensation and personnel-related expenses.