Clinical trialsCompany release

Trevi starts Phase 3 OCEAN-2 trial of Haduvio and reaches FDA alignment on non-IPF ILD cough

🇺🇸 Trevi Therapeutics, Inc. (TRVI) · Mon 09 Nov 2026

Trevi Therapeutics reported Q3 2026 results, citing a Phase 3 start in IPF chronic cough, a positive FDA meeting on non-IPF ILD cough and $299.4 million in cash.

Trevi Therapeutics reported its third-quarter 2026 results on 9 November, announcing that it has started OCEAN-2, a Phase 3 trial of Haduvio (oral nalbuphine extended-release) in chronic cough associated with idiopathic pulmonary fibrosis (IPF).

The company also said it held a positive meeting with the US Food and Drug Administration on its development programme for chronic cough in interstitial lung disease (ILD) other than IPF. Trevi plans to begin a Phase 2 dose-ranging trial of about 120 patients in the first quarter of 2027.

On intellectual property, the US Patent and Trademark Office issued a Notice of Allowance for a patent covering dosing of Haduvio in patients with hepatic impairment. The patent is expected to expire in 2041. A Notice of Allowance indicates that the office has approved the claims, with the patent itself to follow once formalities are completed.

Financially, Trevi reported cash of $299.4 million and a net loss of $21.5 million for the quarter. The company's headline says this provides a cash runway into 2030. No further detail on trial design, endpoints or timelines for OCEAN-2 was available in the material reviewed.

What it means for your team

  • Regulatory teams tracking cough therapies should note FDA alignment on the non-IPF ILD plan, with a Phase 2 dose-ranging study due to start in Q1 2027.
  • The hepatic-impairment dosing patent allowance points to a defined dosing approach for that population, which is relevant to future labelling and clinical pharmacology discussions.
  • Market-access and pipeline analysts can note the stated cash runway into 2030, which covers the Phase 3 OCEAN-2 programme and the planned Phase 2 study.

Company's press release (SEC filing): Trevi Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Trevi Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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