Expanded Access Policy for MTX-463

Expanded access, also called compassionate use, refers to the use of an investigational therapy outside of a clinical trial designed to evaluate safety and efficacy. The purpose of expanded access is to diagnose, prevent, or treat a serious or immediately life-threatening condition in a patient using medicines that have not yet been approved by the Food and Drug Administration (FDA).

Mediar Therapeutics is dedicated to advancing the development of innovative therapies for patients with serious or life-threatening conditions. MTX-463 is undergoing rigorous clinical evaluation to determine its safety and efficacy. As part of our commitment to patient safety and scientific integrity, we must ensure that any potential benefits of MTX-463 outweigh the risks. Given that we are still in the early stages of understanding MTX-463’s therapeutic profile and its risks and benefits, we cannot offer it through expanded access at this time. 

Providing MTX-463 outside of clinical trials at this early stage could compromise the integrity of our ongoing studies, potentially delaying the generation of the robust data needed to support regulatory approval and wider patient access. We are committed to adhering to FDA regulations and guidelines, which require a thorough understanding of a drug’s benefit-risk profile before it can be made available through expanded access.

We understand the urgency and need for new treatments for serious and life-threatening conditions. As we progress through the clinical development of MTX-463 and gather more comprehensive data, we will continually reassess our expanded access policy. Our goal is to ensure that patients in need can access MTX-463 safely and effectively, whether through clinical trials or future expanded access programs. 

For more information about our research and development efforts, clinical trials, or future updates on our expanded access policy, please contact us:

Email: info@mediartherapeutics.com
Phone: (617) 564-1370
Address: Mediar Therapeutics, Inc.
20 Overland St., Suite 520
Boston, MA 02215