Trevi's Haduvio: A Breath of Hope for Chronic Cough Sufferers

NEW HAVEN, CT – January 08, 2026 – Trevi Therapeutics is charting a decisive path forward for its investigational drug, Haduvio™, potentially bringing relief to millions suffering from relentless, debilitating chronic coughs for which no approved therapies exist. The clinical-stage biopharmaceutical company announced significant strategic updates ahead of its participation in the annual LifeSci Partners Corporate Access Event, signaling a pivotal year for its lead candidate.

The company confirmed it has scheduled a critical End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for the first quarter of 2026. This meeting will focus on the development of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Following a successful meeting, Trevi plans to initiate a Phase 3 program for this indication in the first half of the year. Concurrently, the company is preparing to launch a Phase 2b trial for refractory chronic cough (RCC) within the same timeframe.

"We are excited as we begin 2026 to continue the clinical development of Haduvio in our key chronic cough indications," said Jennifer Good, President and CEO of Trevi Therapeutics. "We expect that 2026 will be a year of focused execution at Trevi as we work to advance Haduvio a step closer to patients suffering from these debilitating chronic cough conditions."

Addressing a Desperate Unmet Need

The conditions Trevi aims to treat represent a vast area of unmet medical need. Chronic cough, defined as a cough lasting more than eight weeks, is not merely an annoyance; for many, it is a life-altering symptom. Patients with IPF, a rare disease that scars the lungs, often experience a constant, hacking cough that can exceed 1,500 times per day. This symptom severely degrades quality of life and is associated with a higher risk of disease progression and respiratory hospitalizations. Of the approximately 150,000 IPF patients in the U.S., up to two-thirds suffer from this uncontrolled chronic cough, with no FDA-approved treatments available to them.

Similarly, refractory chronic cough (RCC) affects an estimated 2-3 million people in the U.S. alone. This condition is diagnosed when a persistent cough continues despite treatment for all identifiable underlying causes, such as asthma or acid reflux. Believed to be driven by a hypersensitive cough reflex, RCC can lead to physical exhaustion, social isolation, anxiety, and even depression. For these patient populations, the advancement of a potentially effective therapy is monumental news.

The Science of Silencing the Cough

Haduvio (oral nalbuphine ER) stands apart from other therapies in the pipeline due to its unique mechanism of action. It is a kappa agonist and a mu antagonist (KAMA), meaning it targets two different types of opioid receptors involved in the nervous system's control of the cough reflex. This dual-action approach works both centrally in the brain and peripherally in the nerves of the lungs, offering a comprehensive method to calm the hypersensitive neural pathways that trigger chronic coughing.

This mechanism distinguishes Haduvio from the leading class of competitors, P2X3 receptor antagonists, such as Merck's gefapixant and GSK's camlipixant. While P2X3 inhibitors focus on a specific receptor on sensory nerve fibers, Haduvio’s broader KAMA mechanism may offer efficacy across different types of chronic cough. Trevi has emphasized that Haduvio is the only investigational therapy to have demonstrated a statistically significant reduction in cough frequency in separate clinical trials for both IPF-related chronic cough and RCC, underscoring its potential versatility.

Backed by Strong Data and Financial Footing

Trevi's confidence is built on a foundation of robust clinical data. The company's Phase 2b CORAL trial in IPF patients showed that Haduvio achieved a statistically significant reduction in 24-hour cough frequency, with the highest dose reducing coughs by over 60% compared to baseline. Similarly, the Phase 2a RIVER trial in RCC patients demonstrated a 67% reduction in cough frequency from baseline.

In both trials, the drug was generally well-tolerated, with a safety profile consistent with previous studies of nalbuphine. The most common side effects included manageable events like constipation, nausea, and somnolence. These promising results provide a strong basis for the upcoming discussions with the FDA and the design of the late-stage trials.

Supporting this clinical momentum is a solid financial position. As of its last quarterly report, Trevi held nearly $195 million in cash and equivalents, providing a financial runway projected to last into 2028. This capital is expected to be sufficient to fund the planned Phase 3 and Phase 2b trials, a crucial factor that de-risks the company's ambitious development plans. This financial strength, combined with strong clinical data, has earned the company a "Strong Buy" consensus rating from market analysts, with many forecasting significant upside for the company's stock as it moves closer to potential commercialization.

The upcoming EOP2 meeting with the FDA represents the next major catalyst for Trevi and the millions of patients awaiting a viable treatment. Positive alignment with the agency would clear the path for the final stages of clinical testing, moving Haduvio one step closer to potentially becoming the first approved therapy for chronic cough in IPF and a much-needed option for the broader RCC population. For those who have suffered in silence, the developments of 2026 could bring the first real hope for quiet, and sound of, relief.