Ethyreal does not currently provide access to our investigational products outside of our clinical trials.

Ethyreal Bio, Inc. (Ethyreal) is a biotechnology company advancing targeted therapies for autoimmune conditions driven by TSHR. We are committed to conducting clinical trials to evaluate the safety and effectiveness of new potential treatments, which is a necessary and required step before seeking approval by the Food and Drug Administration (FDA) or other regulatory agencies. At this time, our investigational products are not available through an Expanded Access Program. Access to our investigational therapies is currently only available through enrollment in our clinical trials.

Expanded Access Program (EAP) refers to the potential pathway for patients with a serious or immediately life-threatening disease or condition to obtain treatment with an investigational medicine outside of a clinical trial. The intent of an EAP is to provide patients access to treatment when no comparable or satisfactory alternative therapy options are available. In the future, Ethyreal may consider making one or more of its investigational products available through an EAP and expanded access may be appropriate when a request is made by a patient’s treating physician and the following apply:

  • The patient has a serious or immediately life-threatening disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

If you have questions, please speak with your physician, or have your physician contact medinfo@ethyrealbio.com.

Ethyreal reserves the right to revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record if such record becomes available.