Trevi wins FDA alignment for two Phase 3 IPF cough trials

Trevi Therapeutics, Inc. is moving its lead program for IPF-related chronic cough into late-stage testing after reaching overall alignment with the U.S. Food and Drug Administration at an End-of-Phase 2 meeting.

Rhea-AI Filing Summary

Trevi Therapeutics, Inc. is moving its lead program for IPF-related chronic cough into late-stage testing after reaching overall alignment with the U.S. Food and Drug Administration at an End-of-Phase 2 meeting. The company plans two pivotal Phase 3 trials of nalbuphine ER tablets, both randomized, double-blind, placebo-controlled, multicenter and global, using a 54 mg twice-daily dose.

The first trial is planned to enroll about 300 patients with 52 weeks of fixed dosing and a primary endpoint at 24 weeks. The second trial is planned to enroll about 130 patients with 12 weeks of fixed dosing. In both, patients will be randomized 2:1 to nalbuphine ER or placebo, and the primary efficacy endpoint will be the relative change from baseline in 24-hour cough frequency, measured by an objective cough monitor. These designs remain subject to the FDA’s final protocol review.

Insights

Biotech clinical development analyst

FDA alignment allows Trevi to advance nalbuphine ER into two Phase 3 IPF cough trials.

Trevi Therapeutics obtained overall alignment with the FDA on its remaining IPF-related chronic cough development plan, which is a key step between Phase 2 and registration. The strategy centers on two pivotal, global, randomized, double-blind, placebo-controlled Phase 3 trials of nalbuphine ER tablets at 54 mg twice daily.

One trial is planned to enroll about 300 patients over 52 weeks of fixed dosing, with a primary endpoint at 24 weeks. The second trial targets about 130 patients over 12 weeks of fixed dosing. Both use relative change in 24-hour cough frequency as the primary endpoint, measured objectively, which may help reduce subjectivity in efficacy assessment.

The company plans to run the two trials in parallel, initiating the first in the second quarter of 2026 and the second in the second half of 2026, though the designs are still subject to final protocol review by the FDA. Future disclosures in company filings may provide more detail on recruitment progress, data timing, and any adjustments requested by regulators.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

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What did Trevi Therapeutics (TRVI) announce about its IPF-related chronic cough program?

Trevi Therapeutics announced it reached overall alignment with the FDA at an End-of-Phase 2 meeting for its IPF-related chronic cough program. The company now plans two pivotal Phase 3 nalbuphine ER trials, supporting a future New Drug Application submission if results are favorable.

How many Phase 3 trials will Trevi Therapeutics (TRVI) run for nalbuphine ER in IPF-related chronic cough?

Trevi Therapeutics plans two pivotal Phase 3 clinical trials of nalbuphine ER for IPF-related chronic cough. Both will be randomized, double-blind, placebo-controlled, multicenter and global studies designed to support a potential New Drug Application if they meet their efficacy and safety goals.

What are the planned sizes and durations of Trevi Therapeutics’ Phase 3 IPF cough trials?

One Phase 3 trial is planned to enroll about 300 IPF-related chronic cough patients with 52 weeks of fixed dosing and a primary endpoint at 24 weeks. The second is planned for about 130 patients with 12 weeks of fixed dosing using the same primary efficacy endpoint.

What is the primary endpoint in Trevi Therapeutics’ Phase 3 nalbuphine ER trials?

The primary endpoint in both Phase 3 trials is the relative change from baseline in 24-hour cough frequency, measured as coughs per hour. An objective cough monitor will be used to compare nalbuphine ER at 54 mg twice daily against placebo in IPF-related chronic cough patients.

When does Trevi Therapeutics (TRVI) plan to start its Phase 3 IPF-related chronic cough trials?

Trevi Therapeutics plans to start the first Phase 3 trial in the second quarter of 2026 and the second Phase 3 trial in the second half of 2026. Both timelines and trial designs remain subject to the FDA’s final protocol review before initiation.

How will patients be randomized in Trevi Therapeutics’ Phase 3 IPF cough trials?

In each Phase 3 trial, patients with IPF-related chronic cough will be randomized in a 2:1 ratio to receive nalbuphine ER or placebo. This means more patients receive active treatment while maintaining a placebo control group for robust comparison of efficacy and safety.

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

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Accepted by SEC EDGAR 03/09/2026 - 04:35 PM EDT Learn about SEC filing dates

false000156388000015638802026-03-092026-03-09

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 9, 2026

Trevi Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware		001-38886		45-0834299
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

195 Church Street, 16th Floor New Haven, Connecticut		06510
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (203) 304-2499

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common stock, $0.001 par value per share		TRVI		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events

On March 9, 2026, Trevi Therapeutics, Inc., a Delaware corporation (the “Company”), announced results of the Company’s End-of-Phase 2 meeting with the U.S. Food and Drug Administration (the “FDA”). At the meeting, the Company gained overall alignment on the plan for the remaining idiopathic pulmonary fibrosis (“IPF”)-related chronic cough 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.

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.

Forward-Looking Statements

Statements contained in this Current Report on Form 8-K 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 the Company’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 the Company’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 the Company’s ability to execute on its strategy; uncertainties with respect to regulatory authorities’ views as to the data from the Company’s clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including the Company’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 Current Report on Form 8-K 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.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

		TREVI THERAPEUTICS, INC.
Date: March 9, 2026		By:	/s/ David C. Hastings
			Name: David C. Hastings
			Title: Chief Financial Officer

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