Business Context and Reporting Period
This Form 8-K was filed by Trevi Therapeutics, Inc. on March 9, 2026, reporting an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its idiopathic pulmonary fibrosis (IPF)-related chronic cough development program.
Key Financial Metrics
The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on clinical development milestones and regulatory alignment rather than financial performance.
Material Changes and Clinical Developments
The Company achieved overall alignment with the FDA on the development plan for its drug candidate, nalbuphine ER tablets (Haduvio). Key developments include:
- Agreement to conduct two pivotal Phase 3 clinical trials in parallel.
- Confirmation of remaining Phase 1 clinical studies required to support the New Drug Application (NDA).
- Both Phase 3 trials will be randomized, double-blind, placebo-controlled, multicenter, global trials evaluating 54 mg twice-a-day dosing.
- Primary efficacy endpoint for both trials is the relative change from Baseline in 24-hour cough frequency.
Guidance, Outlook, and Risks
Outlook and Timeline:
- First Phase 3 trial initiation is targeted for the second quarter of 2026.
- Second Phase 3 trial initiation is targeted for the second half of 2026.
- The first trial plans to enroll approximately 300 patients with a 52-week fixed dosing period (primary endpoint at 24 weeks).
- The second trial plans to enroll approximately 130 patients with a 12-week fixed dosing period.
- Forward-looking statements are subject to uncertainties regarding the success, cost, and timing of clinical trials.
- Positive data from earlier trials may not predict results in later trials.
- Uncertainties exist regarding the Company's ability to fund future operations and clinical trials.
- Trial designs remain subject to final FDA protocol review.
Investor Verification Checklist
- Verify the Company's current cash runway and ability to fund the planned Phase 3 trials through 2026 and beyond.
- Confirm the final FDA approval of the Phase 3 trial protocols prior to initiation.
- Monitor the actual enrollment rates and start dates for the two Phase 3 trials against the Q2 and H2 2026 targets.
- Review subsequent filings for any updates on the Phase 1 studies required to support the NDA.