Trevi Therapeutics Announces Publication of Data from the Phase 2b IPF Chronic Cough Trial of nalbuphine ER in the Journal of the American Medical Association (JAMA)

Trevi Therapeutics (Nasdaq: TRVI) announced that key Phase 2b CORAL trial results for oral nalbuphine ER in idiopathic pulmonary fibrosis (IPF) chronic cough were published in JAMA on Jan 22, 2026.

Rhea-AI Summary

Trevi Therapeutics (Nasdaq: TRVI) announced that key Phase 2b CORAL trial results for oral nalbuphine ER in idiopathic pulmonary fibrosis (IPF) chronic cough were published in JAMA on Jan 22, 2026. The trial showed a statistically significant reduction in 24-hour objective cough frequency across all dose groups at Week 6, with significant effects as early as Week 2. More than 60% of treated patients achieved ≥50% reduction in 24-hour cough frequency at Week 6. Patient-reported outcomes aligned with objective monitoring. Safety was consistent with prior data; discontinuations due to adverse events were 6% in treated groups versus 5% for placebo.

Positive

• Statistically significant 24-hour cough reduction at Week 6
• > 60% of nalbuphine ER patients reached ≥50% cough reduction at Week 6
• Patient-reported outcomes consistent with objective cough monitoring
• Serious adverse events 1.6% in nalbuphine ER groups versus 10.0% placebo

Negative

• Common adverse events included nausea, vomiting, constipation and somnolence
• Discontinuation due to adverse events in nalbuphine ER groups 5.6%

Argus Jan 22 session

+6.21% close to close 1.9x rel. volume Open Argus

Details

News Market Reaction – TRVI

On Jan 22, the day this news came out, TRVI closed 6.21% above the previous close. That session’s volume was 1.9x the stock’s average daily volume.

Data tracked by StockTitan Argus for the Jan 22 session.

Key Figures

Responders at Week 6: Over 60% Cough reduction threshold: 50% reduction AE discontinuations – nalbuphine ER: 5.6% +3 more

Responders at Week 6

Over 60%

Nalbuphine ER-treated patients with ≥50% reduction in 24-hour cough frequency vs baseline

Cough reduction threshold

50% reduction

Definition of meaningful decrease in 24-hour cough frequency vs baseline

AE discontinuations – nalbuphine ER

5.6%

Discontinuation rate due to adverse events in combined nalbuphine ER dose groups

AE discontinuations – placebo

5.0%

Discontinuation rate due to adverse events in placebo group

Serious AEs – placebo

4 patients (10.0%)

Non-fatal serious adverse events in placebo arm

Serious AEs – nalbuphine ER

2 patients (1.6%)

Non-fatal serious adverse events in nalbuphine ER-treated patients

Historical Context

5 past events · Latest: Jan 15

5 events

1. Jan 15

   Dividend tax details

   24h Move

   -2.6%

   Clarified 2025 dividend tax allocations and composition for shareholders.

2. Jan 08

   Strategic pipeline update

   24h Move

   -4.3%

   Outlined End-of-Phase 2 FDA meeting and planned Phase 3 and Phase 2b trials.

3. Dec 04

   CFO appointment

   24h Move

   -1.0%

   Named a new CFO with extensive financing and commercialization experience.

4. Nov 13

   Q3 2025 earnings

   24h Move

   -3.3%

   Reported Q3 loss and detailed cash runway, pipeline milestones, and trial data.

5. Nov 06

   Earnings date notice

   24h Move

   +0.0%

   Scheduled Q3 2025 earnings call and webcast logistics for investors.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2b, idiopathic pulmonary fibrosis, interstitial lung disease, refractory chronic cough, +3 more

7 terms

phase 2b medical

"key results from the Phase 2b CORAL trial of oral nalbuphine ER"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

idiopathic pulmonary fibrosis medical

"chronic cough in patients with idiopathic pulmonary fibrosis (IPF)"

Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.

interstitial lung disease medical

"non-IPF interstitial lung disease (non-IPF ILD)"

A group of lung conditions that cause inflammation and scarring of the thin tissue between the air sacs, which makes it harder for oxygen to pass into the blood; imagine the lungs’ fine filters becoming stiff and less effective. Investors care because reports of interstitial lung disease can affect a drug’s safety profile, trigger regulatory warnings or label changes, and shift demand for treatments or create liability risks that influence a company’s valuation.

refractory chronic cough medical

"non-IPF ILD, and refractory chronic cough (RCC)"

A refractory chronic cough is a long-lasting cough that persists despite standard medical evaluation and treatment, typically lasting eight weeks or more and not improving with usual therapies. Investors should care because it represents a clear unmet medical need that can drive demand for new drugs, devices, or diagnostics—similar to a stubborn problem customers keep returning to a store for until a better solution appears—affecting market potential and regulatory attention.

patient-reported outcome medical

"Patient-reported outcome measure of cough frequency was consistent"

Patient-reported outcome is information gathered directly from patients about their symptoms, quality of life, or ability to perform everyday activities, without interpretation by clinicians. Investors care because these measures can determine whether a treatment wins regulatory approval, gains reimbursement, and attracts customers — similar to how product reviews influence buyer demand and a company’s sales prospects.

adverse events medical

"Discontinuation rates due to adverse events were similar"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

serious adverse events medical

"Serious adverse events (all non-fatal) were reported for four patients"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Statistically-significant reduction in the relative change from baseline in 24-hour objective cough frequency observed across all dose groups of nalbuphine ER at Week 6 with statistically-significant cough reduction as early as Week 2, the first time point measured

Over 60% of nalbuphine ER-treated patients achieved at least a 50% reduction in 24-hour cough frequency at Week 6 vs baseline

Patient-reported outcome measure of cough frequency was consistent with reduction observed with objective cough monitoring

NEW HAVEN, Conn., Jan. 22, 2026 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy oral nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that the key results from the Phase 2b CORAL trial of oral nalbuphine ER for the treatment of chronic cough in patients with IPF have been published in the Journal of the American Medical Association (JAMA).

"The publication of these positive Phase 2b results with nalbuphine ER in JAMA represents an important validation of the trial findings and highlights the significance of chronic cough in patients with IPF," said James Cassella, PhD, Chief Development Officer of Trevi Therapeutics. "The statistically-significant reduction in 24-hour objective cough frequency across all dose groups shows the potential that nalbuphine ER has for the treatment of chronic cough in patients with IPF. We look forward to continuing the development of nalbuphine ER, and thank all the patients, investigators, and study staff, who have participated in our clinical trials to get us to this point."

Philip Molyneaux, MD, PhD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London, said, "Chronic cough continues to represent a major unmet need in the care of my patients with IPF and imposes a significant burden on their day-to-day lives. As an investigator for the trial, I was thrilled to see the consistency between objective and patient-reported outcomes, demonstrating that the patients are not only experiencing fewer objective coughs, but overall feeling an improvement as well. These results reinforce the need for continued evaluation of nalbuphine ER."

Access the publication here.

The safety results of the CORAL trial were generally consistent with the known safety profile of nalbuphine ER from previous trials. Discontinuation rates due to adverse events were similar in the combined nalbuphine ER dose groups (5.6%) and placebo group (5.0%). The most common adverse events experienced included: nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth. Serious adverse events (all non-fatal) were reported for four patients (10.0%) in the placebo group and for two patients (1.6%) treated with nalbuphine ER.

About Idiopathic Pulmonary Fibrosis (IPF) Chronic Cough
Chronic cough in patients with IPF is a condition with high unmet need and no FDA-approved therapies. There are ~150,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life.    

About the Phase 2b CORAL Trial
The Phase 2b Cough Reduction in IPF with nalbuphine ER (CORAL) trial was a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg twice daily) compared to placebo for the treatment of chronic cough in patients with IPF over a 6-week treatment period. 165 patients with IPF chronic cough were randomized 1:1:1:1 to one of three nalbuphine ER dose groups or placebo with an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial was the relative change in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for the modified intent-to-treat (mITT) population at the end of Week 6 versus Baseline for nalbuphine ER compared to placebo. The mITT population consisted of all patients who were randomized and received at least one dose of study drug or placebo. 

About Trevi Therapeutics, Inc.    
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.

Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. 

For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn. 

Investor Contact 
Jonathan Carlson 
Trevi Therapeutics, Inc. 
(203) 654 3286 
carlsonj@trevitherapeutics.com

Media Contact 
Rosalia Scampoli 
914-815-1465 
rscampoli@marketcompr.com 

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SOURCE Trevi Therapeutics, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Trevi Therapeutics (TRVI) publish in JAMA on Jan 22, 2026 about nalbuphine ER?

Key Phase 2b CORAL results showing a statistically significant reduction in 24-hour objective cough frequency across all dose groups and > 60% of treated patients achieving ≥50% cough reduction at Week 6.

How quickly did nalbuphine ER show cough reduction in the TRVI Phase 2b trial?

Statistically significant cough reduction was observed as early as Week 2, the first time point measured.

What safety findings were reported for nalbuphine ER in the CORAL trial (TRVI)?

Safety was said to be consistent with prior trials; common adverse events included nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and discontinuations were 5.6% for treated groups versus 5.0% for placebo.

What proportion of TRVI trial patients achieved a clinically large cough reduction with nalbuphine ER?

> 60% of nalbuphine ER–treated patients achieved at least a 50% reduction in 24-hour cough frequency at Week 6 versus baseline.

Did patient-reported outcomes match objective cough monitoring in the TRVI study?

Yes; patient-reported measures of cough frequency were reported to be consistent with reductions observed via objective cough monitoring.

What were the serious adverse event rates in the TRVI CORAL trial?

Serious adverse events were reported at 1.6% in nalbuphine ER–treated patients and 10.0% in placebo patients.