Expanded Access Policy

Newleos Therapeutics, Inc. is a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders 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.

General Policy

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.

Rationale

This policy reflects several important considerations:

  • Early Stage of Development: Our investigational products are in early clinical development, and their safety, efficacy, optimal dosing, and risk profile have not yet been fully characterized.
  • Patient Safety: Providing access outside of controlled clinical trials may expose patients to unknown or unacceptable risks and could compromise appropriate medical oversight.
  • Clinical Trial Integrity: 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.
  • Resource Constraints: As a small, early-stage biotechnology company, our manufacturing capacity and operational resources are limited and must be focused on conducting clinical trials required for regulatory evaluation.
  • Regulatory Responsibility: 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

Patients seeking access to Newleos’ investigational products are encouraged to discuss eligibility for ongoing or future clinical trials with their treating physician. 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.