Trevi Therapeutics Schedules Phase 2 Trials for Chronic Cough in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 08 2026
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Source: PRnewswire
- FDA Meeting Scheduled: Trevi Therapeutics plans to hold an End-of-Phase 2 meeting with the FDA in Q1 2026 to align on its chronic cough treatment program, which aims to advance the clinical development of Haduvio.
- Clinical Trial Initiation: The company expects to initiate a Phase 2b trial for refractory chronic cough in the first half of 2026, providing new treatment options for patients with high unmet needs in this area.
- Market Demand Analysis: In the U.S., approximately 150,000 patients with idiopathic pulmonary fibrosis face uncontrolled chronic cough, indicating significant market potential and urgency for this treatment, which could greatly enhance patient quality of life.
- Strategic Execution Plan: The CEO of Trevi stated that 2026 will be a pivotal year focused on advancing Haduvio's clinical development, aiming to provide effective treatment solutions for chronic cough patients and further solidify its position in the biopharmaceutical sector.
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Analyst Views on TRVI
Wall Street analysts forecast TRVI stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for TRVI is 21.22 USD with a low forecast of 16.00 USD and a high forecast of 25.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
9 Analyst Rating
9 Buy
0 Hold
0 Sell
Strong Buy
Current: 10.510
Low
16.00
Averages
21.22
High
25.00
Current: 10.510
Low
16.00
Averages
21.22
High
25.00
About TRVI
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), chronic cough in patients with non-IPF interstitial lung disease, and refractory chronic cough. Haduvio is an oral extended-release (ER) formulation of nalbuphine. Nalbuphine is a mixed kappa-opioid receptor agonist and mu-opioid receptor antagonist. It has conducted a Phase II clinical trial and an open-label extension study of Haduvio in pruritus in patients with prurigo nodularis and a Phase IIb/III clinical trial. The Company’s Haduvio development programs include Chronic Cough in IPF Program, RCC Program, and Prurigo Nodularis Program. The Company’s subsidiary is Trevi Therapeutics Limited.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Trevi Therapeutics Reports Positive Phase 2b Results for Nalbuphine ER, Over 60% Cough Frequency Reduction at Week 6
- Clinical Trial Results: Trevi Therapeutics announced in JAMA that the Phase 2b CORAL trial demonstrated a statistically significant reduction in 24-hour cough frequency at Week 6, with over 60% of patients achieving at least a 50% reduction, indicating nalbuphine ER's potential for treating chronic cough in IPF patients.
- Patient-Reported Consistency: The consistency between patient-reported cough frequency and objective monitoring results highlights that patients not only experienced fewer coughs but also reported overall improvements, underscoring the significant burden chronic cough imposes on IPF patients' quality of life.
- Safety Results: The safety profile of the CORAL trial was consistent with previous nalbuphine ER studies, with discontinuation rates due to adverse events at 5.6% for nalbuphine ER and 5.0% for placebo, indicating a favorable safety profile for the drug.
- Market Demand: With approximately 150,000 IPF patients in the U.S., two-thirds of whom suffer from uncontrolled chronic cough, there is a pressing need for effective treatment options, and the development of nalbuphine ER could address this unmet medical need.
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Trevi Therapeutics Reports Significant Cough Frequency Reduction with Nalbuphine ER in Phase 2b Trial
- Clinical Trial Results: Trevi Therapeutics published Phase 2b CORAL trial results in JAMA, showing statistically significant reductions in 24-hour objective cough frequency across all nalbuphine ER dose groups at Week 6, indicating the drug's potential for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
- Patient Response Consistency: Over 60% of patients treated with nalbuphine ER achieved at least a 50% reduction in 24-hour cough frequency by Week 6, with patient-reported outcomes aligning with objective monitoring results, underscoring the drug's clinical value and overall patient improvement.
- Safety Analysis: The safety profile from the CORAL trial was consistent with previous studies, showing a 5.6% discontinuation rate due to adverse events in the nalbuphine ER group, comparable to 5.0% in the placebo group, indicating good safety for further development.
- Market Demand: With approximately 150,000 patients suffering from IPF in the U.S., two-thirds of whom experience uncontrolled chronic cough, the development of nalbuphine ER addresses this significant unmet medical need and has the potential to enhance patient quality of life while reducing morbidity and mortality risks.
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