---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-098676"
form_type: "8-K"
ticker: "TRVI"
cik: "0001563880"
company_name: "Trevi Therapeutics, Inc."
filed_at: "2026-03-09T23:59:59+00:00"
generated_at: "2026-05-15T17:41:52.705824+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Trevi Therapeutics gains FDA alignment on Phase 3 plan for nalbuphine ER in IPF cough; first trial Q2 2026

## Summary
- End-of-Phase 2 FDA meeting: overall alignment on IPF-related chronic cough development program including two pivotal Phase 3 trials and Phase 1 studies for NDA support.
- First Phase 3 trial (~300 patients, 52-week dosing, primary endpoint at 24 weeks) expected to start Q2 2026; second Phase 3 (~130 patients, 12-week dosing) in H2 2026.
- Both trials randomized, double-blind, placebo-controlled, global, evaluating nalbuphine ER 54 mg BID vs placebo with 2:1 randomization.
- Primary endpoint for both: relative change from baseline in 24-hour cough frequency measured by objective cough monitor.
- Trial designs are subject to final FDA protocol review.

## SEC filing metadata
- accession: 0001193125-26-098676
- form_type: 8-K
- ticker: TRVI
- cik: 0001563880
- company_name: Trevi Therapeutics, Inc.
- filed_at: 2026-03-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563880/000119312526098676/0001193125-26-098676-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563880/000119312526098676/trvi-20260309.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-098676
- JSON: https://secwatch.observer/filing/0001193125-26-098676.json
- Plain text: https://secwatch.observer/filing/0001193125-26-098676.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.