Expanded Access Policy for Quisinostat

Viriom, Inc.
Last updated: November 5, 2026

Our approach

Viriom, Inc. is developing quisinostat, an investigational medicine being studied as adjuvant treatment for high-risk, nonmetastatic uveal melanoma following definitive local therapy. Quisinostat is not approved by the FDA or any other regulatory authority, and its safety and effectiveness have not been established.

Clinical trials provide a structured setting to evaluate investigational medicines and are the preferred route for access. We recognize that some patients with serious or immediately life-threatening conditions may be unable to participate in a clinical trial and may have no comparable or satisfactory treatment alternatives.

Expanded access, sometimes called compassionate use, is a potential pathway for such patients to receive an investigational medicine outside a clinical trial, subject to applicable regulatory requirements and the company’s agreement to provide the medicine.

Current availability

Viriom does not supply quisinostat outside of clinical trials and does not offer expanded access (compassionate use). Quisinostat is available only to patients enrolled in a clinical trial. Supply of investigational drug is limited, and adjuvant treatment may continue for an extended period, so we cannot ensure that a patient could complete a full course of treatment outside a trial. We believe clinical trials are the best way to give patients access while establishing whether quisinostat is safe and effective.

Viriom therefore does not evaluate individual expanded access requests. If this changes, we will update this policy with the criteria and process that would apply.

How to contact us

Physicians, patients, and caregivers with questions about this policy may contact:

Viriom Expanded Access Contact
Email: expandedaccess@viriom.com
Telephone: +1 (858) 794-4860 (Monday to Friday, 9:00 a.m. to 5:00 p.m. Pacific Time)

Please use the subject line “Quisinostat Expanded Access Inquiry.”

Please do not include the patient’s name or other directly identifying information.

Acknowledgment

We anticipate acknowledging receipt of inquiries within five (5) business days, excluding US federal holidays, and will help physicians connect with the clinical trial described below.

Acknowledgment confirms receipt only. It does not constitute agreement to provide quisinostat.

Because quisinostat is not available outside clinical trials, Viriom cannot support emergency requests.

Clinical trial information

The Phase 2 Trial of Adjuvant Quisinostat in High-Risk Uveal Melanoma, led by Dr. Lutzky at the University of Miami, is enrolling at sites in the United States. Information is available on ClinicalTrials.gov under NCT06932757. The study record provides information about eligibility, participating sites, study contacts, and recruitment status. Patients interested in quisinostat should ask their physician about referral to this study. Physicians may also contact Viriom, and we will help them connect with the study.

Expanded access availability information: There is currently no expanded access record for quisinostat on ClinicalTrials.gov.

Policy updates

Viriom may revise this policy as clinical evidence, supply, development plans, or other circumstances change. Updates will be posted on this webpage.

Publication of this policy does not guarantee that any individual patient will receive quisinostat.