Trevi Therapeutics Advances Haduvio Development with FDA End-of-Phase 2 Meeting and Phase 2b Trial Plans for Chronic Cough Treatment
Key Insights
Trevi Therapeutics has secured an FDA End-of-Phase 2 meeting scheduled for the first quarter of 2026 to discuss the regulatory pathway for Haduvio in treating chronic cough in idiopathic pulmonary fibrosis patients.
The company plans to initiate a Phase 3 program for chronic cough in IPF patients and a Phase 2b trial for refractory chronic cough, both in the first half of 2026.
Haduvio is the first investigational therapy to demonstrate statistically significant reduction in cough frequency across both IPF chronic cough and refractory chronic cough patient populations.
Trevi Therapeutics announced strategic updates for its investigational therapy Haduvio (oral nalbuphine ER) ahead of the 15th Annual LifeSci Partners Corporate Access Event, outlining key regulatory milestones and clinical trial plans for 2026. The clinical-stage biopharmaceutical company is developing Haduvio for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC).
FDA Regulatory Pathway for IPF Chronic Cough
The FDA has granted Trevi an End-of-Phase 2 meeting scheduled for the first quarter of 2026. This meeting will focus on the clinical development and regulatory pathway for the New Drug Application of nalbuphine ER for treating chronic cough in IPF patients. Following this regulatory discussion, the company expects to initiate its Phase 3 program of nalbuphine ER in this patient population during the first half of 2026.
"We have an End-of-Phase 2 meeting scheduled with the FDA, and we hope to align on our development program for the treatment of chronic cough in patients with IPF and then initiate that program," said Jennifer Good, President and CEO of Trevi Therapeutics.
Refractory Chronic Cough Development
In parallel with the IPF program, Trevi plans to initiate a Phase 2b trial in patients with RCC in the first half of 2026. This represents a continuation of the company's multi-indication approach to addressing chronic cough conditions.
Unique Mechanism of Action
Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. The therapy is the first and only investigational treatment to show a statistically significant reduction in cough frequency in clinical trials across both patients with IPF chronic cough and patients with RCC. Notably, nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.
Addressing Significant Unmet Medical Need
The chronic cough conditions targeted by Haduvio represent substantial unmet medical needs with no FDA-approved therapies currently available. Approximately 150,000 U.S. patients have IPF, with two-thirds facing uncontrolled chronic cough. Additionally, around 228,000 U.S. patients have non-IPF ILD, with 50-60% experiencing uncontrolled chronic cough.
The clinical impact of chronic cough is severe, with patients coughing up to 1,500 times per day. This persistent coughing and associated damage may lead to higher risks of morbidity and mortality, including worsening disease, increased risk of progression, more respiratory hospitalizations, and declining quality of life.
For refractory chronic cough, there are approximately 2-3 million U.S. patients affected. RCC is defined as persistent cough lasting more than eight weeks despite treatment for underlying conditions such as asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip. The condition is believed to be associated with cough reflex hypersensitivity involving both central and peripheral nervous systems and is highly debilitating, impacting patients physically, psychologically, and socially.
2026 Strategic Focus
Good emphasized the company's focused execution strategy for the coming year: "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."
The company's new Chief Financial Officer, David Hastings, will represent Trevi at the LifeSci Partners Corporate Access Event alongside other senior management team members during the J.P. Morgan Healthcare Conference week in San Francisco from January 12-14, 2026.