Trevi Therapeutics Announces Oral Presentation Accepted at the CHEST 2026 Annual Meeting

Trevi flags a major unmet need but withholds trial results ahead of its CHEST 2026 reveal.

What the company is saying

Trevi Therapeutics is spotlighting the upcoming oral presentation of its Phase 2b CORAL trial results for oral nalbuphine ER in chronic cough associated with idiopathic pulmonary fibrosis (IPF) at the CHEST 2026 Annual Meeting. The company emphasizes the scale of the unmet need, citing ~140,000 U.S. IPF patients (two-thirds with uncontrolled cough), ~228,000 non-IPF ILD patients (50–60% with uncontrolled cough), and 2–3 million with refractory chronic cough (RCC). Trevi frames Haduvio as an investigational therapy that has shown statistically significant reductions in cough frequency and patient-reported outcome improvements in prior clinical trials, but does not provide any new efficacy or safety data in this announcement. The tone is confident and focused on opportunity, with mechanistic claims about Haduvio’s action as a kappa agonist and mu antagonist, but these are presented as beliefs rather than new findings. The company is clear that nalbuphine is not scheduled by the DEA and that there are currently no FDA-approved therapies for these conditions. The announcement positions the CHEST 2026 presentation as the next major milestone, without previewing the actual clinical results.

What the data suggests

The announcement provides detailed trial design: a double-blind, randomized, placebo-controlled Phase 2b study with 165 IPF patients, three nalbuphine ER dose arms (27 mg, 54 mg, 108 mg twice daily), a 2-week titration and 4-week fixed dosing, and a primary endpoint of relative change in 24-hour cough frequency at week 6. Epidemiological data highlight the addressable market: ~140,000 U.S. IPF patients (two-thirds with uncontrolled cough), ~228,000 non-IPF ILD patients (50–60% with uncontrolled cough), and 2–3 million with RCC. Patients with these conditions may cough up to 1,500 times per day, underlining the severity and impact. The company claims Haduvio has shown statistically significant reductions in cough frequency and improved patient-reported outcomes, but provides no numerical efficacy or safety results from the CORAL trial. No financial data, revenue, or commercial projections are disclosed. The evidence is limited to trial structure and market need, with no new data to independently assess clinical or commercial progress.

Analysis

The announcement is upbeat in tone, emphasizing the upcoming presentation of Phase 2b trial results and the high unmet need in chronic cough associated with IPF and related conditions. However, it does not disclose any topline efficacy or safety data from the trial, nor does it provide financial or operational metrics. The claim that Haduvio showed statistically-significant reductions in cough frequency and improvements in patient-reported outcomes is not substantiated with numerical data in this release. The only forward-looking statement is the intent to propose a trade name, and there is no discussion of regulatory timelines, commercialization, or capital outlay. The gap between narrative and evidence is moderate: the company highlights potential and unmet need but does not overstate imminent benefits or make unsupported commercial projections. The absence of efficacy data means the true signal cannot be stronger than weak_positive, and the moderate hype level reflects the promotional framing of unquantified clinical progress.

Risk flags

• ●No efficacy or safety data from the Phase 2b CORAL trial are disclosed in this announcement, leaving the clinical value of Haduvio unproven until the CHEST 2026 presentation. This creates significant uncertainty for investors regarding the likelihood of regulatory or commercial success.
• ●The company’s claims of statistically significant reductions in cough frequency and improved patient-reported outcomes are not supported by numerical data in this release, raising the risk that actual results may not meet expectations set by the narrative.
• ●There are currently no FDA-approved therapies for chronic cough in IPF, non-IPF ILD, or RCC, so even positive trial results would face regulatory uncertainty and potential delays before any commercial value can be realized.

Bottom line

Trevi Therapeutics is drawing attention to its upcoming Phase 2b CORAL trial results for Haduvio in chronic cough, but has not released any efficacy or safety data ahead of the CHEST 2026 conference. The company quantifies a large U.S. patient population—~140,000 with IPF, ~228,000 with non-IPF ILD, and 2–3 million with RCC—underscoring the potential market if Haduvio proves effective. However, without topline results, investors have no basis to judge the clinical or commercial prospects of the drug. The narrative is opportunity-driven but lacks substantiating data, and the absence of FDA-approved therapies in these indications means regulatory hurdles remain high. The most important takeaway is that the true value of this program will only become clear once detailed trial results are disclosed at CHEST 2026; until then, the investment case is speculative.

Announcement summary

(NASDAQ:TRVI) Trevi Therapeutics, Inc. announced that results from the Phase 2b CORAL trial of oral nalbuphine ER for chronic cough in idiopathic pulmonary fibrosis (IPF) will be presented as an oral presentation at the CHEST 2026 Annual Meeting of the American College of Chest Physicians, scheduled for October 18–21, 2026, in Phoenix, Arizona. The presentation, titled 'Patient-Reported Outcomes Show Early and Sustained Improvement Following Nalbuphine Extended-Release in Patients with Idiopathic Pulmonary Fibrosis Experiencing Chronic Cough,' will be delivered by Philip Molyneaux, MD, PhD, on October 20 from 1:45 p.m. to 2:30 p.m. MST at the Phoenix Convention Center Exhibit Hall Rapid Fire Area 2D. The Phase 2b CORAL trial was a double-blind, randomized, placebo-controlled, parallel-arm study evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg twice daily) versus placebo over a 6-week treatment period in 165 patients with IPF chronic cough. Patients were randomized 1:1:1:1 to one of the three nalbuphine ER dose groups or placebo, with a 2-week titration period followed by 4 weeks of fixed dosing. The primary efficacy endpoint was the relative change in 24-hour cough frequency (coughs per hour), measured by an objective cough monitor, for the modified intent-to-treat (mITT) population at Week 6 versus Baseline. The mITT population included all patients randomized and who received at least one dose of study drug or placebo. Haduvio™ (oral nalbuphine extended-release) is Trevi's investigational therapy for chronic cough in IPF, non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). In clinical trials, Haduvio showed a statistically-significant reduction in cough frequency, consistent across baseline cough frequencies, and improvements in patient-reported outcomes in both IPF-related chronic cough and RCC. Haduvio is believed to act as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors involved in chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough in IPF and non-IPF ILD represents a high unmet need with no FDA-approved therapies. There are approximately 140,000 U.S. patients with IPF, with two-thirds experiencing uncontrolled chronic cough. There are approximately 228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. Patients may cough up to 1,500 times per day, which can lead to increased morbidity, mortality, disease progression, respiratory hospitalizations, and reduced quality of life. RCC affects an estimated 2-3 million U.S. patients and is defined as a persistent cough lasting more than 8 weeks despite treatment for underlying conditions. RCC is associated with cough reflex hypersensitivity and is highly debilitating. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER, but its safety and efficacy have not been evaluated by any regulatory authority.

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