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Trevi Therapeutics is a clinical-stage biopharma company focused on developing Haduvio, an oral extended-release formulation of nalbuphine, to treat chronic cough in idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease and refractory chronic cough (RCC). The drug acts as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough control while aiming to limit abuse risk.
Trevi reported positive Phase 2b CORAL data in IPF-related chronic cough, with Haduvio showing placebo-adjusted reductions in 24-hour cough frequency of roughly 48–60% across dose groups at Week 6, alongside supportive patient-reported outcomes and a safety profile consistent with prior studies. A prior Phase 2a CANAL trial also showed large, statistically significant cough reductions.
In RCC, the Phase 2a RIVER trial demonstrated a 57% placebo‑adjusted reduction in 24‑hour cough frequency and strong responder rates, with no treatment-emergent serious adverse events. Trevi plans two parallel Phase 3 IPF-related chronic cough trials starting in 2026, plus Phase 2b trials in non-IPF ILD cough and RCC, and is running Phase 1 studies on abuse potential, drug-drug interactions and respiratory safety to support a potential NDA.
Trevi Therapeutics reported fourth-quarter and full-year 2025 results and outlined plans to advance its chronic cough pipeline. The company is developing Haduvio, an oral nalbuphine extended-release therapy for chronic cough in idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough.
Trevi ended 2025 with $188.3 million in cash, cash equivalents and marketable securities, which it expects will fund operations into 2028. For 2025, research and development expenses fell to $33.5 million from $39.4 million, while general and administrative costs rose to $15.9 million from $12.1 million. The net loss narrowed to $42.8 million from $47.9 million in 2024.
The company gained overall FDA alignment on its Phase 3 program for IPF-related chronic cough and plans two pivotal Phase 3 trials beginning in 2026. It also plans Phase 2b trials in 2026 for refractory chronic cough and for non-IPF ILD-related chronic cough, and will host an Investor and Analyst Day on May 7, 2026.
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.
Cassella James V reported acquisition or exercise transactions in this Form 4 filing.
Trevi Therapeutics, Inc. reported that Chief Development Officer James V. Cassella received a grant of stock options covering 215,000 shares of common stock on February 19, 2026. The options were granted at a price of $0.0000 per share as a compensation award.
The 215,000 underlying shares are scheduled to vest in equal monthly installments through February 19, 2030, and vesting depends on Cassella’s continued service with the company. Following this award, he holds stock options for 215,000 shares directly.
Trevi Therapeutics, Inc. reported that company officer Christopher Galletta received a grant of stock options covering 35,000 shares of common stock. The award was made on February 19, 2026 as a compensation-related acquisition, not an open-market purchase.
The 35,000 underlying shares are scheduled to vest in equal monthly installments through February 19, 2030, conditioned on Galletta’s continued service with the company. This filing simply records the new equity award and Galletta’s resulting direct ownership of these options.
Trevi Therapeutics, Inc. reported that its Chief Scientific Officer, Thomas Sciascia, received a grant of stock options covering 85,000 shares of common stock. The options were awarded at an exercise price of $0.00 per share, reflecting a compensatory grant rather than an open-market purchase. According to the filing, these 85,000 underlying shares are scheduled to vest in equal monthly installments through February 19, 2030, and the vesting is conditioned on his continued service with the company.
Trevi Therapeutics, Inc. reported that President and CEO Jennifer L. Good received a grant of stock options covering 675,000 shares of common stock. The award was granted on February 19, 2026 at no cost on grant and represents a compensation-related acquisition, not an open-market purchase.
The 675,000 underlying shares are scheduled to vest in equal monthly installments through February 19, 2030, so long as she continues her service with the company. This structure ties the potential ownership benefit to her ongoing tenure over the multi-year vesting period.
Simon Farrell reported acquisition or exercise transactions in this Form 4 filing.
Trevi Therapeutics Chief Commercial Officer Simon Farrell received a grant of stock options covering 160,000 shares of common stock. The award was made on February 19, 2026 as an equity incentive.
The 160,000 underlying shares are scheduled to vest in equal monthly installments through February 19, 2030, conditioned on Farrell’s continued service with the company.
Rubric Capital Management LP and David Rosen report beneficial ownership of 3,766,749 shares of Trevi Therapeutics, Inc. common stock, equal to 2.94% of the outstanding shares based on 128,230,134 shares as of October 31, 2025. They share voting and dispositive power over all reported shares and indicate that the position is held in the ordinary course of business. They state the holdings were not acquired and are not held to change or influence control of Trevi Therapeutics.
Trevi Therapeutics, Inc. received an updated Schedule 13D/A from New Enterprise Associates–affiliated funds and managers, correcting earlier disclosures after exercises of certain NEA 16 warrants and acquisition of the underlying common shares before Amendment No. 7.
As of February 13, 2026, the NEA funds report beneficial ownership of a combined 15,074,080 shares of Trevi common stock, representing 11.6% of the class, based on 130,081,986 shares including NEA 16 warrants. This includes 12,273,280 shares held by NEA 16 and 948,948 shares held by NEA 18 Venture Growth Equity, plus 1,851,852 shares underlying NEA 16 warrants. Individual manager Forest Baskett is deemed to beneficially own 14,125,132 shares, or 10.9%. The filing states the firm shares were acquired for investment purposes and notes no specific current plans for corporate changes, though the funds may buy or sell additional shares over time.