Trevi Therapeutics: Pioneering Respiratory Disease Innovation with Near-Term Catalysts and Expansive Market Potential

Trevi Therapeutics, a clinical-stage biopharmaceutical company, is emerging as a pivotal player in respiratory disease innovation, with its investigational therapy Haduvio™ (nalbuphine extended-release) poised to address significant unmet needs in chronic cough management for patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Following its high-impact presentation at the CHEST 2025 Annual Meeting, the company's near-term catalysts and strategic positioning warrant close scrutiny for investors seeking exposure to a rapidly evolving therapeutic landscape.

Near-Term Catalysts: Robust Clinical Data and FDA Engagement

Trevi's Phase 2b CORAL trial of Haduvio for IPF chronic cough delivered compelling results, with the highest dose (108 mg twice daily) achieving a 60.2% reduction in 24-hour cough frequency compared to a 16.9% reduction in the placebo group, according to Trevi's CORAL topline results. These findings, presented by Professor Philip Molyneaux at CHEST 2025, underscore the therapy's potential to become a first-in-class treatment in a market dominated by symptomatic therapies. The trial also demonstrated rapid efficacy as early as Week 2 and favorable tolerability, with discontinuation rates comparable to placebo.

Complementing these results, the Phase 2a RIVER trial for RCC showed a 57% placebo-adjusted reduction in cough frequency (p<0.0001), with all secondary endpoints met, according to Trevi's Q1 2025 results. Associate Professor Imran Satia's presentation of patient-reported outcomes at CHEST 2025 further highlighted the therapy's impact on quality of life, a critical metric for regulatory and payer acceptance.

With topline data from CORAL already announced in Q2 2025 and the FDA engagement roadmap expanding to include non-IPF interstitial lung diseases (ILDs), Trevi is well-positioned to initiate Phase 3 trials in 2026, per Trevi's Q1 2025 results. The company's proactive strategy to merge data from non-IPF ILD studies with its IPF indication could accelerate regulatory pathways and broaden market access.

Market Potential: Capturing a $6.12 Billion Opportunity by 2030

The IPF market, valued at $4.39 billion in 2025, is projected to grow at a compound annual growth rate (CAGR) of 6.84%, reaching $6.12 billion by 2030, according to the Mordor Intelligence report. Current therapies like pirfenidone and nintedanib focus on slowing fibrosis progression but lack efficacy in managing chronic cough, a debilitating symptom affecting up to 80% of IPF patients, according to Coherent Market Insights. Haduvio's dual central and peripheral mechanism-targeting both opioid receptors and cough reflex pathways-positions it to capture a significant share of this market.

For RCC, the global treatment market is expected to expand from $1.05 billion in 2024 to $1.75 billion by 2033 at a 6.1% CAGR, per Verified Market Reports. Here, Trevi faces competition from P2X3 receptor antagonists like GSK's BLU-5937 and Merck's Gefapixant, which have shown promise but are hampered by side effects such as dysgeusia. Haduvio's 67% reduction in objective cough frequency in the RIVER trial, as reported by Trevi's Q1 2025 results, coupled with its favorable safety profile, could differentiate it in a market where patient adherence remains a challenge.

Strategic Expansion and Commercialization Readiness

Trevi's financial and operational strategy further strengthens its investment case. The company reported $103.3 million in cash reserves as of Q1 2025, sufficient to fund operations through Q4 2026, according to Trevi's Q1 2025 results. This runway supports its plan to launch a specialty sales force targeting 80 U.S. ILD centers, with a team of 50–75 representatives focused on high-prescribing pulmonologists. A proposed $60,000–$85,000 annual pricing model aligns with the value proposition of addressing a severe, unmet need while remaining competitive with existing IPF therapies, as outlined in Trevi's Q1 2025 results.

Moreover, Trevi's pipeline expansion into non-IPF ILDs-such as sarcoidosis and hypersensitivity pneumonitis-could unlock additional market potential. By proposing two IPF-focused studies to the FDA and integrating non-IPF ILD data, the company aims to secure broader label indications and extend its commercial footprint, per Trevi's Q1 2025 results.

Conclusion: A Compelling Investment Thesis

Trevi Therapeutics' strategic alignment with high-growth respiratory disease markets, supported by robust clinical data and a clear regulatory pathway, presents a compelling opportunity for investors. With near-term catalysts including Phase 3 trial readiness and a $6.12 billion IPF market by 2030, the company is well-positioned to capitalize on its first-mover advantage in chronic cough management. As the competitive landscape evolves, Haduvio's differentiated profile and Trevi's disciplined commercialization strategy could drive significant shareholder value.