Trevi Therapeutics, Inc.

Trevi Therapeutics, Inc. is a U.S.-based biopharmaceutical company focused on developing Haduvio, an oral therapy for chronic cough and related respiratory conditions. The company’s work centers on clinical development, regulatory approval, and eventual commercialization of Haduvio in the United States and through partners outside the U.S.

19.66

19.66

— Trevi Therapeutics, Inc.
%
Haduvio clinical development100% Clinical-stage development of Haduvio across respiratory cough indications.
Regulatory and approval pathway0% Activities supporting FDA and other regulatory submissions for Haduvio.
Future commercialization0% Planned U.S. and ex-U.S. commercialization of approved Haduvio products.

Trevi does not currently sell commercial products; its eventual customers would be physicians, patients, and payors in...

  • Pulmonologistsprimary

    Specialists who would prescribe Haduvio for IPF and non-IPF ILD-related chronic cough.

  • Refractory chronic cough specialistsprimary

    Pulmonologists and allergists treating RCC patients who have failed other therapies.

  • Third-party payorsprimary

    Insurers and government payors that decide coverage and reimbursement levels.

  • Patients with chronic coughprimary

    End users of the therapy, especially those with IPF, non-IPF ILD, or RCC.

  • Ex-U.S. commercial partnerssecondary

    Potential collaborators that would help market and distribute Haduvio outside the U.S.

Trevi is headquartered in the United States and expects initial commercialization of Haduvio to be U.S.-focused...

  • •Headquartered in the United States
  • •Planned initial commercialization is U.S.-focused
  • •Ex-U.S. sales would likely rely on third-party partners
  • •Regulatory approval is needed in each target market
  • •Global expansion depends on local reimbursement and market access

Trevi’s strategy is to advance Haduvio through late-stage clinical development, secure regulatory approval, and build a...

01
Complete late-stage clinical development of Haduvioshort-term

Approval depends on demonstrating safety and efficacy in target cough populations.

02
Prepare for U.S. commercializationmedium-term

A focused specialty sales model is needed if the product is approved.

03
Secure reimbursement and market accessmedium-term

Coverage and reimbursement will determine whether the product can be adopted at scale.

04
Protect intellectual property and supply chain readinesslong-term

Patent protection and reliable manufacturing support long-term commercial value.

Trevi is a clinical-stage company with no product sales, so its value depends on successful development, approval, and...

critical

Clinical development failure

Haduvio must prove safety and efficacy across target cough indications before approval.

Scope
Phase 3, Phase 2b, and supportive studies
Materiality
high
high

Regulatory approval risk

FDA and other authorities may require more data, delay approval, or reject applications.

Scope
IPF, non-IPF ILD, and RCC programs
Materiality
high
high

Financing risk

The company expects to fund operations through external capital until product revenue exists.

Scope
Equity, debt, collaborations, strategic transactions
Materiality
high
high

Reimbursement and pricing risk

Payors may restrict coverage or require pricing concessions, limiting adoption.

Scope
U.S. and international market access
Materiality
high
medium

Manufacturing and third-party dependence

Drug substance and finished product supply rely on external vendors and cGMP compliance.

Scope
CROs, contract manufacturers, drug substance suppliers
Materiality
medium
medium

Intellectual property risk

Patent scope, validity, and foreign protection affect exclusivity and long-term value.

Scope
U.S. and foreign patent portfolios
Materiality
medium
Research and development accruals
Can shift reported R&D expense between periods
Stock-based compensation
Affects operating loss and non-cash reconciliation
Marketable securities valuation
Can affect reported investment gains/losses
Lease accounting
Affects balance sheet and operating expense presentation
Future revenue recognition and deductions
Will affect net product revenue and margins

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: 29.4.2026