Trevi Therapeutics has begun clinical trials for Haduvio, a potential first-in-class oral therapy designed to treat chronic cough in patients with idiopathic pulmonary fibrosis.
- Haduvio is an oral, extended-release nalbuphine therapy targeting two protein receptors that regulate the cough reflex in the nerves and brain
- Approximately two-thirds of U.S. IPF patients suffer from uncontrolled chronic cough, with some coughing up to 1,500 times daily
- Previous trial results showed the 54-mg dose reduced cough frequency by 36.5% compared to placebo and significantly reduced cough severity
U.S. developer Trevi Therapeutics has begun enrollment for the first of two global clinical trials of Haduvio, a potential treatment for people who experience chronic cough due to idiopathic pulmonary fibrosis (IPF).
According to Trevi, approximately two-thirds of U.S. patients who have IPF suffer from uncontrolled chronic cough, with some coughing up to 1,500 times a day. Currently, there are no FDA-approved treatments specific to IPF-related cough. Haduvio is an oral, extended-release nalbuphine therapy that targets two protein receptors in the nerves and brain that help regulate the cough reflex.
“Haduvio has the potential to become a first-in-class therapy that makes a meaningful difference in patients’ lives,” said Trevi president and CEO Jennifer Good in a press release.
The initial phase 3 trial, OCEAN-1 (NCT07671911), has five locations in Florida, North Carolina and Texas that are currently recruiting IPF patients who are aged 40 years and older with chronic cough for a minimum of eight weeks. Individuals who have been taking a stable dose of an approved antifibrotic medication for at least six weeks are eligible.
Participants will randomly receive either Haduvio 54 mg or placebo twice daily for 52 weeks. The primary endpoint of the trial is reduced 24-hour cough frequency after 26 weeks, as measured by an objective cough monitor.
Secondary endpoints include substantial reduction in cough frequency, absolute changes in cough severity and changes in breathlessness. Researchers will also measure ancillary respiratory symptoms and cough-related quality of life as well as monitor safety and tolerability of Haduvio.
The second clinical trial, OCEAN-2, which is expected to begin in September 2026, will similarly compare twice-daily, 54-mg Haduvio versus placebo but for a 12-week period.
Both phase 3 studies build on results from the phase 2b CORAL trial, which evaluated twice-daily Haduvio at three doses — 27 mg, 54 mg and 108 mg — versus placebo for six weeks. Findings showed the 54-mg dose reduced cough frequency by 36.5% compared to placebo, significantly reduced cough severity and reduced the impact of coughing on patients’ daily lives.
Results of the two trials are expected in late 2027 (OCEAN-2) and mid-2028 (OCEAN-1) and, if successful, will support an application to the U.S. Food and Drug Administration (FDA) for regulatory approval.
