Core Viewpoint - Trevi Therapeutics is advancing its investigational therapy Haduvio™ for chronic cough related to idiopathic pulmonary fibrosis (IPF) and plans to initiate two pivotal Phase 3 clinical trials in 2026, following a successful End-of-Phase 2 meeting with the FDA [1][2]. Group 1: Clinical Trials - The first Phase 3 trial is set to begin in Q2 2026, while the second trial is expected to start in the second half of 2026 [1]. - Both trials will be randomized, double-blind, placebo-controlled, and multicenter, evaluating the safety and efficacy of nalbuphine ER tablets at a dosing of 54 mg twice daily [2]. - The first trial aims to enroll approximately 300 patients with a 52-week fixed dosing period, with a primary endpoint at 24 weeks [2]. - The second trial plans to enroll around 130 patients with a 12-week fixed dosing period, with the same primary efficacy endpoint of relative change in 24-hour cough frequency [2]. Group 2: Unmet Medical Need - Chronic cough in IPF patients represents a significant unmet medical need, with around 150,000 patients in the U.S., two-thirds of whom experience uncontrolled chronic cough [3]. - Patients may cough up to 1,500 times per day, leading to increased morbidity and mortality risks, including disease progression and reduced quality of life [3]. Group 3: Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ for chronic cough in patients with IPF, non-IPF interstitial lung disease, and refractory chronic cough [4]. - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and refractory chronic cough [4]. - The drug acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough control [4].