Trevi Therapeutics Announces Completion of End-of-Phase 2 Meeting with the FDA, Gaining Alignment for Its Development Program for Idiopathic Pulmonary Fibrosis-Related Chronic Cough
Rhea-AI Summary
Trevi Therapeutics (NASDAQ: TRVI) reported that it completed an End-of-Phase 2 meeting with the FDA and gained alignment on its development plan for Haduvio (oral nalbuphine ER) in IPF-related chronic cough. Two pivotal Phase 3 trials will run in parallel, with initiation targeted in Q2 2026 and the second in H2 2026. The program also includes remaining Phase 1 studies the company expects to complete to support an NDA.
Both randomized, double-blind, placebo-controlled global trials will test 54 mg BID dosing, use objective 24-hour cough-frequency as the primary endpoint, and randomize patients 2:1 versus placebo.
Positive
- FDA alignment achieved at End-of-Phase 2 meeting
- Two pivotal Phase 3 trials to run in parallel starting 2026
- Planned Phase 3 dosing: 54 mg BID with objective cough endpoint
- First Phase 3 trial planned enrollment about 300 patients
Negative
- Additional Phase 1 studies are still required before NDA support
- Phase 3 trial designs remain subject to final FDA protocol review
- First pivotal trial includes 52 weeks fixed dosing, lengthening timeline
News Market Reaction – TRVI
In the Mar 9 session, TRVI declined 12.03%, reflecting a significant negative market reaction. Argus tracked a peak move of +11.1% during that session. Argus tracked a trough of -11.5% from its starting point during tracking. Our momentum scanner triggered 30 alerts that day, indicating elevated trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 02 | Phase 2b topline | Positive | -3.0% | Positive Phase 2b CORAL results with significant cough reduction across dose groups. |
| May 20 | Phase 2a analyses | Positive | -0.3% | Additional positive analyses from Phase 2a RIVER trial in refractory chronic cough. |
| Mar 10 | Phase 2a topline | Positive | +41.2% | Positive topline Phase 2a RIVER results with strong placebo-adjusted cough reduction. |
| Feb 25 | Trial enrollment | Neutral | +4.9% | Completion of enrollment for Phase 2b CORAL trial in IPF chronic cough. |
| Dec 12 | Sample size review | Positive | +44.6% | Positive SSRE outcome confirming no change to 160-patient CORAL sample size. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial news has often driven large moves, with several strong positive reactions but also some negative or muted responses, yielding an average move of 17.46% on similar announcements.
Over the past year, Trevi has steadily advanced Haduvio through multiple clinical stages. Earlier RIVER and CORAL trial readouts in 2024–2025 showed statistically significant cough reductions and led to both sharp rallies and occasional pullbacks. Completion of CORAL enrollment and a positive sample size re-estimation set up the pivotal path. Today’s End-of-Phase 2 FDA alignment on IPF-related chronic cough Phase 3 design follows that sequence, converting prior trial success into a defined registrational program.
Key Terms
idiopathic pulmonary fibrosis medical
interstitial lung disease medical
refractory chronic cough medical
new drug application regulatory
phase 3 medical
randomized, double-blind, placebo-controlled medical
bid medical
objective cough monitor medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
The Company will conduct two Phase 3 clinical trials of nalbuphine ER for the treatment of patients with IPF-related chronic cough
First pivotal trial is on track to initiate in the second quarter of 2026, with the second pivotal trial expected to initiate in the second half of 2026
NEW HAVEN, Conn., March 09, 2026 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (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 the results of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). At the meeting, the Company gained overall alignment on the plan for the remaining development program. The Company plans to conduct two pivotal Phase 3 clinical trials and obtained agreement on the remaining Phase 1 clinical studies that the Company expects to conduct to support the New Drug Application (NDA) submission. The Company plans to conduct the Phase 3 trials in parallel with each other and is on track to initiate the first Phase 3 trial in the second quarter of 2026 and the second Phase 3 trial in the second half of 2026.
“We very much appreciate the FDA’s careful review of our IPF-related chronic cough program to date and the highly collaborative discussions we had during the meeting,” said James Cassella, PhD, Chief Development Officer of Trevi Therapeutics. “We clarified the path forward for our Phase 3 program and received useful guidance on the remaining Phase 1 studies to be conducted. We are well positioned to initiate pivotal parallel Phase 3 trials beginning in the second quarter of 2026 and to execute on the remaining development program.”
Jennifer Good, President and CEO of Trevi Therapeutics, added, “The End-of-Phase 2 meeting was an important milestone for the Company, and we are grateful for the guidance from the FDA. With no FDA-approved therapies for IPF-related chronic cough, it remains highly burdensome for patients living with IPF and is a condition which has historically had limited options. Our team is focused on advancing Haduvio for these patients and potentially addressing this urgent unmet need.”
The Phase 3 trials will both be randomized, double-blind, placebo-controlled, multicenter, global trials evaluating the safety and efficacy of nalbuphine ER tablets, with 54 mg twice-a-day (BID) dosing, for the treatment of patients with IPF-related chronic cough. Patients enrolled in the trials will be randomized 2:1 to either nalbuphine ER or placebo. The first of the two Phase 3 trials is planned to enroll approximately 300 patients with IPF-related chronic cough and have 52 weeks of fixed dosing, with the primary endpoint at 24 weeks of fixed dosing. The other Phase 3 trial is planned to enroll approximately 130 patients with IPF-related chronic cough and have 12 weeks of fixed dosing. The primary efficacy endpoint for both trials will be the relative change from Baseline in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for nalbuphine ER compared with placebo. These trial designs are subject to final review of the protocols by the FDA.
About Idiopathic Pulmonary Fibrosis (IPF)-Related 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 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.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials, statements regarding FDA guidance, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2025 filed with the Securities and Exchange Commission and in subsequent filings made by the Company with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
IR@trevitx.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
