Forazapadin Expanded Access Policy
Satellos Bioscience, Inc. Last updated Oct. 6, 2026.
Current availability
Forazapadin (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, forazapadin is available only through clinical trials. Satellos is not currently providing forazapadin 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 forazapadin at this time.
How we evaluate expanded access requests
Although we do not offer forazapadin through expanded access at this time, a licensed physician may still submit an expanded access request on behalf of an individual patient. Whether expanded access to an investigational drug can be made available depends on program-level criteria, including:
- the current stage of the forazapadin development program and the safety information available to date;
- whether adequate data exist to support use outside a controlled clinical trial; and
- whether providing the drug outside a clinical trial could interfere with the clinical studies needed to support potential approval and wider availability.
Based on these criteria, and given the current stage of clinical development, Satellos does not grant expanded access to forazapadin at this time. Enrolling in a clinical trial remains the way to access forazapadin.
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 automated acknowledgment of receipt upon submission. Because Satellos does not grant expanded access to forazapadin at this time, we will confirm this position in response to a request.
Clinical trial and availability information
Information about forazapadin clinical trials, including whether expanded access is available, is on ClinicalTrials.gov:
Important information
Posting this policy is not a guarantee of access to forazapadin 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.