Expanded Access Policy

Newleos Therapeutics, Inc. is a clinical-stage biotechnology company developing innovative treatments for life threatening conditions by conducting clinical trials and obtaining marketing approval by the U.S. Food and Drug Administration (FDA) and other regulatory authorities. Our investigational products have not been approved by any regulatory authority for commercial use.

At this time, Newleos does not provide expanded access (also referred to as compassionate use) to its investigational products outside of participation in clinical trials.

Our investigational products are in early clinical development, and their safety, efficacy, optimal dosing, and risk profile have not yet been fully characterized. Providing access outside of controlled clinical trials may expose patients to unknown or unacceptable risks and could compromise appropriate medical oversight.

Limiting access to clinical trials ensures that data are collected in a systematic and scientifically rigorous manner, which is essential for accurately evaluating the benefit–risk profile of our investigational products.

Completion of well-designed clinical trials is the most effective and responsible way to generate the evidence needed to support potential future regulatory approval and broader patient access.

Clinical Trial Participation

Information about active clinical trials, including eligibility criteria and study locations, may be found at  https://clinicaltrials.gov/   or https://euclinicaltrials.eu/

Requests for Information

While we cannot provide investigational products outside of clinical trials at this time, general inquiries regarding clinical development programs or trial availability may be directed to:

Email:  clinicaltrials@newleos.com
Phone:  +1 978 780 5937

Newleos may revise this policy at any time.