Actio Biosciences’ products are known as investigational study drugs, meaning that neither the United States Food and Drug Administration (FDA) nor any regulatory authority from another country has approved them for sale or general use. Actio products are in the early stages of being tested to make sure they are safe and work in the conditions being studied. At times there is interest in accessing study drugs prior to approval, through expanded access. The use of our drugs in patients outside of a clinical trial should not be considered until it is known if they have a favorable safety profile and a potential to provide benefit to patients. We recognize and appreciate that many patients have serious disease symptoms and are desperate for anything that might help. At this time, Actio’s study drugs are not ready to be considered for use outside of a clinical trial.

Controlled clinical trials are necessary for government approval of new medicines to make them available to patients. Actio is focused on developing clinical trials in collaboration with patient advocacy groups, physicians, and health authorities to generate data that will support future approvals for these potential new medicines. For these reasons, Actio is not currently able to provide study drug outside of company sponsored trials. We advise patients and care providers who are interested in our study drugs to enroll in our ongoing and planned clinical trials.

As sufficient safety testing is completed and if a positive benefit-risk profile is established, Actio will re-examine our position on an ongoing basis.

Expanded Access Policy dated: 19 April 2025

Contact Actio Biosciences at info@actiobio.com