Trevi Therapeutics to Detail 2025 Results Amidst Unmet Cough Treatment Need
Event summary
- Trevi Therapeutics will report Q4 and FY2025 financial results and provide business updates on March 17, 2026, at 4:30 PM ET.
- The company is developing Haduvio™ (oral nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and RCC.
- Haduvio is the only therapy demonstrating statistically significant cough reduction across IPF and RCC patients in clinical trials.
- Approximately 2-3 million U.S. patients suffer from refractory chronic cough (RCC), a condition with no FDA-approved therapies.
- Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER, which has not been evaluated by any regulatory authority.
The big picture
Trevi Therapeutics is targeting a significant unmet need in chronic cough management, a condition affecting hundreds of thousands of patients with IPF, ILD, and RCC. The lack of FDA-approved therapies for RCC creates a substantial commercial opportunity, but success will depend on demonstrating clinical benefit and navigating a complex regulatory landscape. The company’s focus on a unique mechanism of action (KAMA) presents both a potential advantage and a risk, as it may require a novel regulatory approach.
What we're watching
- Clinical Adoption
- The success of Haduvio will hinge on physician adoption and patient willingness to try a novel treatment approach for a condition often managed with multiple therapies.
- Regulatory Pathway
- The FDA’s assessment of Haduvio’s efficacy and safety profile, particularly given its unique mechanism of action, will dictate the timeline and potential scope of commercialization.
- Market Penetration
- Trevi’s ability to capture market share within the large RCC patient population will depend on effective marketing and reimbursement strategies, given the existing treatment landscape.
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