SAT-3247 Expanded Access Policy
Satellos Bioscience, Inc. Last updated July 6, 2026.
Current availability
SAT-3247 is an investigational drug. It has not been approved by the U.S. Food and Drug Administration or any other regulatory authority, and its safety and effectiveness have not been established. At this time, SAT-3247 is available only through clinical trials. Satellos is not currently providing SAT-3247 through expanded access, also known as compassionate use or pre-approval access, outside of its clinical trials.
We recognize the urgent need for new treatment options for families living with Duchenne, which is why we are steadfast in our commitment to advancing the clinical program and generating the data needed to support potential approval and wider availability. We require additional data before access outside of clinical trials can be considered. Enrolling in a clinical trial remains the way to access SAT-3247 at this time.
How we evaluate expanded access requests
Although we do not offer SAT-3247 through expanded access at this time, a licensed physician may still submit an expanded access request on behalf of an individual patient. When we receive a request, the factors we consider include:
- whether the patient has a serious or life-threatening condition;
- whether there is no comparable or satisfactory alternative therapy available;
- whether the potential benefit to the patient justifies the potential risks, based on the information available at the current stage of development;
- whether providing the drug outside a clinical trial could interfere with the clinical studies needed to bring SAT-3247 to patients; and
- the current stage of the SAT-3247 program and the safety information available to date.
Given the current stage of clinical development, however, Satellos is not granting expanded access to SAT-3247 at this time.
How to submit a request and contact us
Expanded access requests must be submitted by the patient’s treating physician. Physicians may contact us at expandedaccess@satellos.com. Patients interested in expanded access should speak with their treating physician, understanding that Satellos is not offering expanded access at this time for the reasons stated above.
Our response timing
Requests submitted by a treating physician receive an immediate confirmation of receipt. We will acknowledge each request within seven (7) business days and will communicate our determination following review.
Clinical trial and availability information
Information about SAT-3247 clinical trials, including whether expanded access is available, is on ClinicalTrials.gov:
Important information
Posting this policy is not a guarantee of access to SAT-3247 for any individual patient. Satellos may revise this policy at any time. As the program advances and additional data become available, we will reassess whether expanded access can be offered.