Clinical Trial Outcome Uncertainty: The success of Haduvio in ongoing and future clinical trials for various indications is highly uncertain, and failures could significantly impact the company's prospects.

Regulatory Approval Challenges: Even if clinical trials are successful, obtaining necessary regulatory approvals from agencies like the FDA or EMA for Haduvio is not guaranteed and can involve lengthy processes.

Funding and Capital Needs: Trevi Therapeutics will require significant additional capital to fund its operations, complete clinical development, and prepare for commercialization, which may not be available on favorable terms or at all.