Company Overview

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel treatments for chronic pruritus (severe itching) and related conditions with significant unmet medical need. The company operates within the biotechnology and pharmaceutical research industry and is publicly traded on the NASDAQ under the ticker TRVI. Its core strategy centers on repurposing and reformulating well-characterized molecules using proprietary delivery technology to address conditions that lack effective therapies.

Trevi’s primary product candidate is Haduvio™ (oral nalbuphine extended-release), which is designed to target opioid receptors involved in itch signaling while minimizing central nervous system side effects. The company’s initial focus has been on chronic pruritus associated with primary biliary cholangitis (PBC) and chronic kidney disease-associated pruritus (CKD-aP). Trevi was founded in 2011 and has evolved from early formulation research into a late-stage clinical development company, advancing Haduvio through multiple Phase 2 and Phase 3 clinical programs.

Business Operations

Trevi Therapeutics operates as a single-segment clinical-stage biopharmaceutical company, with substantially all activities dedicated to the research, development, and potential commercialization of Haduvio™. The company does not generate product revenue and relies on equity financing and capital markets to fund operations. Research and development activities include clinical trials, regulatory engagement, manufacturing scale-up through third-party contractors, and intellectual property management.

Operationally, Trevi conducts its clinical trials through a network of contract research organizations (CROs) and collaborates with third-party manufacturers for drug substance and drug product production. The company does not currently market or sell any approved products and has no disclosed revenue-generating subsidiaries. Its operations are primarily domestic, with clinical trial sites that may include international locations depending on study design and regulatory requirements.

Strategic Position & Investments

Trevi’s strategic direction is centered on advancing Haduvio™ toward regulatory approval for chronic pruritus indications, particularly in PBC-associated pruritus, where limited treatment options exist. The company’s investment focus is largely internal, prioritizing late-stage clinical trials, regulatory submissions, and lifecycle management opportunities for its lead asset rather than a broad pipeline expansion.

The company has not disclosed major acquisitions or diversified portfolio investments and remains highly concentrated on the success of Haduvio. Strategically, Trevi positions itself by leveraging nalbuphine’s established pharmacology combined with its proprietary extended-release formulation to differentiate on safety and tolerability. Emerging opportunities include evaluating Haduvio in additional pruritic conditions where opioid receptor modulation is clinically relevant.

Geographic Footprint

Trevi Therapeutics is headquartered in the United States, with its principal executive offices located in New Haven, Connecticut. The company’s operational footprint is primarily North America, reflecting its corporate headquarters, management team, and primary regulatory focus with the U.S. Food and Drug Administration.

While Trevi does not maintain a broad international commercial presence, its clinical development activities may involve international clinical trial sites to support patient enrollment and regulatory standards. The company’s long-term geographic strategy is expected to align with future commercialization plans, potentially involving partnerships or licensing arrangements outside the United States.

Leadership & Governance

Trevi Therapeutics is led by an experienced management team with backgrounds in pharmaceutical development, regulatory strategy, and corporate finance. The company emphasizes a leadership philosophy focused on disciplined clinical execution, regulatory rigor, and addressing underserved patient populations through targeted innovation.

Key executives include:

• Jennifer L. Good – President & Chief Executive Officer
• Timothy Noyes – Chief Financial Officer
• Andrew J. Furey, MD – Chief Medical Officer
• Mary K. Stutts – Chief Operating Officer
• Eric Bjerkholt – Chief Business Officer

The company is governed by a board of directors that provides oversight on strategy, risk management, and shareholder interests, consistent with governance standards applicable to U.S.-listed biotechnology companies.