Trevi Therapeutics, Inc.

Trevi Therapeutics, Inc. (NASDAQ: TRVI) is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio, an oral extended-release formulation of nalbuphine, for the treatment of chronic cough in patients with specific respiratory conditions. The company's website is www.trevitherapeutics.com.

Haduvio represents the company's sole product candidate and operates as a kappa receptor agonist and mu receptor antagonist, targeting opioid receptors that play a critical role in controlling chronic cough. The drug acts on the cough reflex arc both centrally and peripherally. Nalbuphine, the active ingredient, has been approved and marketed as an injectable for pain indications for decades in the United States and Europe and is not scheduled as a controlled substance by the Drug Enforcement Agency, which the company believes mitigates abuse potential compared to traditional mu-opioid agonists.

Trevi is developing Haduvio across three primary indications. For idiopathic pulmonary fibrosis-related chronic cough, the company completed a Phase 2b CORAL trial in June 2025 demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups. For refractory chronic cough, the company announced positive Phase 2a RIVER trial results in March 2025 showing a 67 percent reduction in 24-hour cough frequency. The company also plans to develop Haduvio for non-IPF interstitial lung disease-related chronic cough, with a Phase 2b adaptive design trial planned for the second half of 2026.

Following an End-of-Phase 2 meeting with the FDA, Trevi gained alignment on its clinical development pathway, including two pivotal Phase 3 trials planned to initiate in the second quarter of 2026 and the second half of 2026, respectively. The company has retained worldwide commercial rights for Haduvio and plans to commercialize the product through its own focused specialty sales force targeting pulmonologists and other relevant specialists if regulatory approval is obtained.

Trevi relies on third-party contract manufacturers for drug substance and product manufacturing, with a single supplier providing nalbuphine hydrochloride. The company is evaluating alternate sources of supply to mitigate supply chain risk. As a clinical-stage company, Trevi has incurred significant losses since inception and expects to continue incurring losses as it advances its development programs.