Trevi Therapeutics Charts Aggressive Path to Market for Chronic Cough Drug After FDA Alignment
NEW HAVEN, Conn. – March 17, 2026 – Trevi Therapeutics, Inc. (NASDAQ: TRVI) today provided a comprehensive business update following a pivotal fourth quarter, detailing a clear regulatory roadmap for its lead candidate, Haduvio (nalbuphine ER), in chronic cough indications. The company's momentum is fueled by positive data from its CORAL and RIVER trials and a recent collaborative End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
In a conference call with analysts, CEO Jennifer Good emphasized that 2025 marked a "major inflection point" for the biopharmaceutical firm. The key catalyst was gaining alignment with the FDA on the development plan for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease affecting approximately 150,000 Americans, two-thirds of whom suffer from debilitating, uncontrolled cough.
"We believe the path forward for our registration trials is clear," stated Good. "With no FDA-approved therapies for IPF-related chronic cough, we are aggressively moving to initiate our Phase III program with the goal of delivering the first targeted treatment to these patients."
Clinical Strategy and Trial Design
The agreed-upon plan involves two global Phase III trials for the IPF indication. The first, a 52-week study with a primary efficacy endpoint at 24 weeks, is slated to begin in Q2 2026 and will enroll roughly 300 patients. A second confirmatory trial, focusing on a 12-week endpoint and enrolling about 130 patients, is expected to start in the second half of the year. The dual-trial approach is designed to robustly demonstrate both durability of effect and confirm primary efficacy, building a substantial safety database required for a New Drug Application (NDA).
Chief Development Officer, Dr. James Cassella, noted that secondary endpoints will capture critical patient-reported outcomes (PROs), including cough severity and the impact on breathlessness—a major concern for patients. "It's very important in this program that we get the patient perspective," Cassella remarked.
Expanding the Pipeline and Financial Runway
Beyond IPF, Trevi is preparing to engage the FDA on a program for chronic cough in non-IPF interstitial lung disease (ILD), a patient population estimated to be more than double the size of the IPF cough market. The company plans an adaptive Phase IIb/III trial design, with a meeting request slated for Q3 2026. A Phase IIb dose-ranging study in refractory chronic cough (RCC) is also on track to begin in Q2.
Newly appointed CFO David Hastings reported a strong cash position of $188 million as of year-end 2025, providing an expected runway into 2028. This capital is projected to fund the company through key milestones, including top-line data from the RCC and non-IPF ILD studies, as well as the 12-week readout from the pivotal IPF trial.
Upcoming Catalysts and Analyst Commentary
Trevi highlighted two major upcoming events: an Investor & Analyst Day in New York City on May 7, and a presentation of new data at the American Thoracic Society (ATS) conference in May. These forums will offer deeper dives into the clinical strategy and commercial preparation.
Market Reaction and Expert Perspectives
The detailed update was met with cautious optimism from observers. "The FDA alignment removes a significant overhang and de-risks the program considerably," noted Dr. Anya Sharma, a biotech equity analyst at Horizon Insights. "Trevi's focused strategy on a high-unmet-need niche within pulmonology is smart, and the commercial synergy between IPF and broader ILD is compelling."
Michael Rostov, a portfolio manager specializing in healthcare, offered a more tempered view: "The execution risk is now front and center. Running two Phase III trials simultaneously is a massive operational undertaking. Their cash runway looks sufficient, but any enrollment delays or unexpected safety signals could pressure that timeline. The market needs to see flawless execution."
Taking a sharper tone, Sarah Chen, a patient advocate for pulmonary fibrosis, commented: "While the corporate progress is encouraging, patients are drowning *now*. Another two-plus years of trials feels like an eternity when every cough is exhausting and frightening. Trevi and the FDA must move with the urgency this suffering demands. 'Aggressive' timelines need to translate into real-world access faster."
The company's shares were active following the call as investors digested the clarified path to potential approval in a market currently devoid of approved therapies.