Expanded Access (Compassionate Use)

Expanded Access (Compassionate Use) Policy

Neutrolis, Inc. is a clinical-stage company developing investigational therapies, including NTR-1011, for serious and life-threatening diseases. Our foremost objective is to establish the safety and efficacy of our investigational therapies through well-controlled clinical trials so that, if approved by regulatory authorities, they can be made available to the broadest possible group of patients as quickly and safely as possible.

In certain circumstances, people living with a serious or immediately life-threatening disease or condition may be able to access an investigational medicine outside of clinical trials when no comparable or satisfactory alternative therapy is available. This pathway is known as “Expanded Access,” and is sometimes also called “Pre-Approval Access” or “Compassionate Use.”

Our goal is to provide access to our investigational medicines at the appropriate time and in a safe manner. We believe enrollment in our ongoing clinical trials is the most effective way of achieving this goal. Therefore, at this time we are unable to provide investigational medicines via expanded access programs, and we do not currently accept or grant any requests for expanded access to any of our investigational medicines outside of our clinical programs.

To learn more about our ongoing clinical programs, please visit clinicaltrials.gov. If you have questions about participating in our clinical trials, please discuss this with your health care provider.

If you have questions about this policy, please contact Neutrolis Medical Affairs at medicalaffairs@neutrolis.com. We aim to acknowledge inquiries within 5-7 business days. Being in contact with us does not guarantee access to any investigational therapy or enrollment in any clinical trial.

We reserve the right to revise this policy at any time, consistent with our obligations under the 21st Century Cures Act.