Expanded Access Policy

Scorpion is committed to bringing new, innovative therapies to patients by conducting rigorous clinical trials and obtaining marketing approval by the U.S. Food and Drug Administration (FDA) and other regulatory authorities.

Expanded access program (EAP), sometimes called compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. 

Our EAP policy is described below:

Several factors consistent with the FDA and other regulatory agencies’ guidelines, are essential when considering expanded access requests:

• The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or open clinical trials)
• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
• The ability to provide a therapy in a fair and equitable manner, so that there is adequate manufacturing capacity to provide therapies across all ongoing clinical trials and expanded access programs
• Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

Given the early stage of our development program, we believe that participation in our clinical trial is the most appropriate way to access our investigational therapy. Therefore, we are not currently making our investigational product available through an expanded access program. If you have additional questions, please speak with your physician, or have your physician contact clinicaltrials@scorpiontx.com.  We anticipate acknowledging receipt of requests sent to this address within five business days.

In line with the 21st Century Cures Act, Scorpion Therapeutics, Inc may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov if such record becomes active.