Trevi Therapeutics
Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio, an oral extended-release nalbuphine therapy targeting chronic cough in IPF, non-IPF ILD, and refractory chronic cough patients, with Phase 3 trials planned to begin in 2026.
- Company typePublic
- Founded2011
- HeadquartersSandy Hook, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Trevi Therapeutics does
Trevi Therapeutics is a clinical-stage biopharmaceutical company founded in 2011 and headquartered in New Haven, Connecticut, listed on NASDAQ under the ticker TRVI. The company is developing Haduvio, an oral extended-release formulation of nalbuphine, a dual-acting opioid with a KAMA (kappa opioid receptor agonist and mu opioid receptor antagonist) mechanism. Trevi is targeting chronic cough in three distinct patient populations: idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (ILD), and refractory chronic cough (RCC). The CORAL Phase 2b trial in IPF chronic cough was published in JAMA in January 2026, and the company completed an End-of-Phase 2 meeting with the FDA in March 2026, with Phase 3 trials planned to initiate in the second half of 2026 across all three indications.
The company's core technology is the reformulation of nalbuphine into an oral extended-release product, combined with the novel application of the KAMA mechanism to chronic cough pathways. Trevi holds 24 issued US and foreign patents covering formulations and methods of use, with a key composition-of-matter patent extending protection to 2039. There are currently no FDA-approved therapies for chronic cough in IPF or RCC, positioning Haduvio as a potential first-in-class therapy in these underserved indications. The addressable patient population is estimated at approximately 140,000 IPF patients and 2-5 million RCC patients in the US.
Trevi is pre-revenue and operates a capital-intensive clinical development business model funded primarily through public equity offerings. The company raised approximately $115.1 million in June 2025 and approximately $150 million in April 2026, bringing pro forma cash to roughly $334 million as of Q1 2026. With a market capitalization of approximately $2.56 billion and 95.76% institutional ownership, Trevi is in a Phase 3 preparation phase, building out commercial leadership (including a new CFO and CCO) in anticipation of a potential first US launch. The company employs 11-50 people and is expected to generate its first commercial revenue following Haduvio's potential regulatory approval, likely via specialty pharmacy distribution to pulmonologists and cough specialists.
Trevi Therapeutics firmographics
Firmographics- Name
- Trevi Therapeutics
- Legal name
- Trevi Therapeutics, Inc.
- Website
- https://trevitherapeutics.com
- Company type
- Public
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio, an oral extended-release nalbuphine therapy targeting chronic cough in IPF, non-IPF ILD, and refractory chronic cough patients, with Phase 3 trials planned to begin in 2026.
- Ownership category
- akta.pro rank
Trevi Therapeutics industry classification
Industry- Product category
- Respiratory Therapeutics
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF)
- akta.pro secondary industry
- Pulmonary Hypertension & Rare Pulmonary Disease Therapies (HLAIAIAG)
Keywords
Where Trevi Therapeutics is headquartered
LocationHeadquarters
- HQ city
- Sandy Hook
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Trevi Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations
Marketing channels4 records
Trevi Therapeutics product offering
Product offeringCore offering
Trevi Therapeutics develops Haduvio (nalbuphine ER), an investigational oral extended-release therapy that acts as a kappa agonist and mu antagonist (KAMA) targeting opioid receptors along the cough reflex arc both centrally and peripherally. The therapy is being advanced through late-stage clinical development for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough (RCC). Haduvio is not yet approved by any regulatory authority.
Product overview
Trevi Therapeutics is a clinical-stage biopharmaceutical company developing a single investigational therapy, Haduvio (nalbuphine ER), an oral extended-release formulation targeting chronic cough conditions. Haduvio acts as a kappa agonist and mu antagonist (KAMA), working both centrally and peripherally along the cough reflex arc. The company is pursuing development for three indications: chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough. Haduvio is not yet approved by any regulatory authority.
Differentiator
Problem solved
Functional benefit
Brands
- Haduvio: Oral nalbuphine ER therapy for chronic cough conditions including IPF-related chronic cough, non-IPF ILD, and refractory chronic cough. Novel KAMA mechanism acting as kappa agonist and mu antagonist targeting opioid receptors along the cough reflex arc.
Products and services
- Haduvio (nalbuphine ER) Haduvio is an investigational oral extended-release nalbuphine therapy that acts as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors along the cough reflex arc both centrally and peripherally. It is being developed for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). The therapy demonstrated statistically significant reductions in cough frequency in Phase 2b CORAL and Phase 2a RIVER trials. Not yet approved by any regulatory authority.
Quantifiable outcome
- 60.2% reduction in 24-hour cough frequency from baseline at 108mg BID dose (p<0.0001) vs 16.9% for placebo in IPF patients
- +4 more outcomes
Companies that use Trevi Therapeutics
Customer profileSegments3 records
Ideal customer profiles3 records
Trevi Therapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Trevi Therapeutics partnerships and signals
Strategic signalScale indicators13 records
Recent moves6 records
Expansion highlights6 records
Trevi Therapeutics competitors and assessment
Company assessmentDirect peers
- GlaxoSmithKline (via Bellus Health acquisition): GSK acquired Bellus Health in 2023 to advance camlipixant (BLU-5937), a P2X3 antagonist in Phase 3 development for refractory chronic cough — the most directly competing late-stage chronic cough program to Trevi's Haduvio (nalbuphine ER).
- Bayer (via NeRRe Therapeutics acquisition): Bayer acquired NeRRe Therapeutics to develop eliapixant and orvepitant for refractory chronic cough; while Bayer later halted the eliapixant program, it remains a direct comparator in the chronic cough therapeutic space alongside GSK's camlipixant.
- Merck & Co. Merck acquired Afferent Pharmaceuticals and advanced gefapixant (MK-7264) — a P2X3 antagonist — for refractory chronic cough. Although Merck withdrew the original FDA application in 2022, the program represents the most direct historical precedent for Haduvio's commercialization trajectory.
- Pliant Therapeutics: Pliant Therapeutics is a clinical-stage biotech developing integrin inhibitors (bexotegrast/PLN-74809) for idiopathic pulmonary fibrosis and primary sclerosing cholangitis, directly overlapping Trevi's IPF patient population and competing for the same pulmonology specialty prescribing audience.
- FibroGen: FibroGen developed pamrevlumab (anti-CTGF) for idiopathic pulmonary fibrosis and other fibrotic diseases — sharing Trevi's IPF patient population and clinical development path, providing a relevant benchmark for IPF therapeutic clinical readouts.
- Bayer (eliapixant program context): Bayer's NeRRe-derived eliapixant (P2X3 antagonist for chronic cough) halted Phase 3 in 2023; Bayer serves as both a precedent (Merck withdrawal) and direct mechanism-class competitor to Haduvio in chronic cough.
Broad incumbents
- Boehringer Ingelheim: Boehringer Ingelheim markets OFEV (nintedanib) and Esbriet (pirfenidone) — the two FDA-approved therapies for idiopathic pulmonary fibrosis. As the incumbent in Trevi's primary IPF-CC indication, BI is the dominant specialist prescriber base that any Haduvio launch would need to leverage.
- United Therapeutics: United Therapeutics is a specialty pharmaceutical company with a dominant pulmonary hypertension franchise (Tyvaso, Remodulin) and orphan/rare disease focus, serving as a public-market comparable for capital-efficient pulmonary specialty pharma business models.
- Insmed: Insmed is a specialty pulmonary pharmaceutical company (brensocatib for bronchiectasis, ARIKAYCE for NTM lung infection) with a similar orphan/rare pulmonary disease commercialization playbook and late-stage clinical assets targeting underserved pulmonary indications.
Emerging players
- Shionogi (chronic cough pipeline): Shionogi has historically been active in cough therapeutics (codeine-based formulations and novel cough candidates) in Asia and selectively in the US, representing a partial-overlap chronic cough competitor with regional strength.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks5 records
Key highlights7 records
Customer concentration
Trevi Therapeutics social profiles
Digital presenceTrevi Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Trevi Therapeutics leadership team
Management profileNumber of profiles
Profiles14 records
Trevi Therapeutics funding detail
Funding detailFunding overview
Funding rounds9 records
Investors15 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Trevi Therapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Trevi Therapeutics
What does Trevi Therapeutics do?
Trevi Therapeutics develops Haduvio (nalbuphine ER), an investigational oral extended-release therapy that acts as a kappa agonist and mu antagonist (KAMA) targeting opioid receptors along the cough reflex arc both centrally and peripherally. The therapy is being advanced through late-stage clinical development for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough (RCC). Haduvio is not yet approved by any regulatory authority.
Is Trevi Therapeutics a public or private company?
Trevi Therapeutics is a public company. It is classified as public and is currently operating.
When was Trevi Therapeutics founded?
Trevi Therapeutics was founded in 2011. It employs 11 to 50 people.
Where is Trevi Therapeutics based?
Trevi Therapeutics is headquartered in Sandy Hook, United States, in the North America region.
Who are Trevi Therapeutics's main competitors?
Direct peers on record are GlaxoSmithKline (via Bellus Health acquisition), Bayer (via NeRRe Therapeutics acquisition), Merck & Co., Pliant Therapeutics, FibroGen and Bayer (eliapixant program context). Broad incumbents are Boehringer Ingelheim, United Therapeutics and Insmed. Shionogi (chronic cough pipeline) is listed as an emerging player.
Does Trevi Therapeutics have an API?
No public API is recorded for Trevi Therapeutics.
What industry is Trevi Therapeutics in?
Trevi Therapeutics's product category is Respiratory Therapeutics. Its primary akta.pro industry code is HLAIACAF, Pulmonology & Allergy Specialty Pharmaceuticals, with a secondary code of HLAIAIAG, Pulmonary Hypertension & Rare Pulmonary Disease Therapies. Its NAICS code is 5417 and its SIC code is 2834.