Trevi Therapeutics, Inc.
TRVI evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for TRVI—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · TRVI
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio (nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and refractory chronic cough, with Phase 3 trials ongoing and a cash position of $54.3M as of 2026-06-30 [sec].
Key risk: No approved products or revenue
BioSniper Score
Based on 5 of 6 signals
Market Cap
$2.39B
Cash Runway
53.0 moLead Asset
haduvio (Phase 3)
Next Catalyst
Phase2_Topline · Dec 31, 2026Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 10 clinical trials · 3 catalysts for Trevi Therapeutics, Inc..
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio (nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and refractory chronic cough, with Phase 3 trials ongoing and a cash position of $54.3M as of 2026-06-30 [sec].
- Haduvio (nalbuphine ER) is being developed for chronic cough in IPF, non-IPF ILD, and RCC, with Phase 3 trials expected to report topline results in the first half of 2028 and second half of 2027 [sec · filed 2026-04-17].
- Cash and equivalents were $54.3M as of 2026-06-30, with net income of -$17.8M and shareholders' equity of $183.2M [sec].
- The company has never generated product revenue and has incurred net losses since inception, with an accumulated deficit of $321.5M as of September 30, 2025 [sec_mda · as of 2025-11-13].
- A Phase 2b trial for non-IPF ILD chronic cough is planned for the second half of 2026, subject to FDA protocol review, with topline results expected in the second half of 2027 [sec · filed 2026-04-17].
- The company expects existing cash to fund operations for at least 12 months from the date of the latest financial statements, but this excludes commercial launch expenses [sec_mda · as of 2026-08-06].
What works
- Haduvio has shown statistically significant results on primary and secondary endpoints in prior trials, with no serious adverse events reported [sec_mda · as of 2026-03-17].
- The company has a clear clinical development plan with multiple Phase 2 and Phase 3 trials targeting large unmet needs in chronic cough [sec · filed 2026-04-17].
- Cash runway is projected to cover operations for at least 12 months, supporting near-term clinical milestones [sec_mda · as of 2026-08-06].
What to weigh
- The company has no approved products and has never generated revenue from product sales, with an accumulated deficit of $321.5M as of September 30, 2025 [sec_mda · as of 2025-11-13].
- Clinical development is subject to regulatory approvals and protocol reviews, which could delay timelines [sec · filed 2026-04-17].
- The company faces significant competition and must establish healthcare coverage and reimbursement if Haduvio is approved [sec_mda · as of 2026-08-06].
- Cash resources do not include commercial launch expenses, requiring additional financing for potential commercialization [sec · filed 2026-04-17].
From the filings
Quoted directly from source documents.
Cash position as of June 30, 2026
“As of June 30, 2026, we had cash, cash equivalents and marketable securities of $318.9 million.”
SEC MD&A · August 6, 2026
Accumulated deficit as of September 30, 2025
“As of September 30, 2025, we had an accumulated deficit of $321.5 million”
SEC MD&A · November 13, 2025
Phase 3 topline results timeline
“The Company expects to have topline results from the first Phase 3 trial in the first half of 2028 and from the second Phase 3 trial in the second half of 2027.”
SEC filings · April 17, 2026
No product revenue and history of losses
“We have not generated any revenue from product sales and, as a result, we have never been profitable and have incurred net losses in each year since commencement of our operations.”
SEC MD&A · November 13, 2025
Catalyst timeline
- 2026-12-31 · Phase2_Topline · haduvio — Phase 2 Readout: haduvio — Topline results from a Phase 2 trial of Haduvio are expected by the end of 2026.
- 2027-12-31 · Phase2_Topline · haduvio — Phase 2 Readout: haduvio — Topline results from another Phase 2 trial of Haduvio are expected by the end of 2027.
- 2028-07-01 · Phase3_Topline — Phase 3 Topline: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphi — Topline results from a Phase 3 trial of nalbuphine (Haduvio) are expected around mid-2028.
Risks & what to watch (4)›
Key risks
- No approved products or revenue — Company has never generated product revenue and has an accumulated deficit of $321.5M as of Sep 2025 [sec_mda · as of 2025-11-13].
- Clinical trial delays — Trial initiations and timelines are subject to FDA protocol reviews and regulatory approvals [sec · filed 2026-04-17].
- Cash runway excludes commercial costs — Existing cash does not cover commercial launch expenses, requiring future financing [sec · filed 2026-04-17].
- Competition and reimbursement — Success depends on establishing coverage and reimbursement against competing technologies [sec_mda · as of 2026-08-06].
What to watch
- Initiation and enrollment of the Phase 2b trial for non-IPF ILD chronic cough in the second half of 2026 [sec · filed 2026-04-17].
- Topline results from the second Phase 3 trial expected in the second half of 2027 [sec · filed 2026-04-17].
- Topline results from the first Phase 3 trial expected in the first half of 2028 [sec · filed 2026-04-17].
- Any updates on FDA protocol reviews for planned trials [sec · filed 2026-04-17].
Sources: SEC filings · SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
53.0 months
D/E 0.03 · 0% dilution
Lead: Phase 3
1 candidate
3 upcoming, next in ~123d
No insider transactions in the last 180 days
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
197
Total value held
$1.32B
| Holder | Shares | Value |
|---|---|---|
| blackrock, inc. | 10,240,186 | $122.2M |
| vanguard capital management llc | 9,957,134 | $118.8M |
| fmr llc | 8,038,061 | $95.9M |
| wellington management group llp | 5,189,088 | $61.9M |
| marshall wace, llp | 3,966,019 | $47.3M |
| mpm bioimpact llc | 3,298,430 | $39.4M |
| viking global investors lp | 3,198,644 | $38.2M |
| alliancebernstein l.p. | 2,845,472 | $35.6M |
| geode capital management, llc | 2,778,231 | $33.2M |
| state street corp | 2,665,313 | $31.8M |
Showing top 10 of 197 institutional holders of Trevi Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of Apr 28, 2026- % of float
- 14.1%
- Days to cover
- 12.4
- Shares short
- 16,139,168
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
TRVI short interestGovernance
Frequently asked questions
What is the AI investment thesis for Trevi Therapeutics, Inc.?
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio (nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and refractory chronic cough, with Phase 3 trials ongoing and a cash position of $54.3M as of 2026-06-30 [sec].
What is Trevi Therapeutics, Inc.'s lead drug candidate?
Trevi Therapeutics, Inc.'s most advanced tracked candidate is haduvio (Phase 3) for Prurigo nodularis.
What is Trevi Therapeutics, Inc.'s next catalyst?
Trevi Therapeutics, Inc.'s next tracked catalyst is a Phase2_Topline event — "Phase 2 Readout: haduvio" — expected December 31, 2026.
Who is the CEO of Trevi Therapeutics, Inc.?
Ms. Jennifer L. Good is the chief executive officer of Trevi Therapeutics, Inc. (TRVI).
Where is Trevi Therapeutics, Inc. headquartered?
Trevi Therapeutics, Inc. (TRVI) is headquartered in New Haven, CT, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.