Early Access Policy
Shionogi Clinical Trials
Shionogi encourages patients and their healthcare providers to learn more about Shionogi’s clinical trial programs here.
Shionogi Early Access
In addition, through its Early Access Programs (EAPs) (also known as compassionate use, managed access, special access, expanded access, named patient, and temporary authorizations for use programs), Shionogi may be able to supply an investigational drug for a patient outside of a clinical trial and in accordance with the local regulatory process when each of the following conditions are met:
Early Access Criteria
- The patient has a serious or immediately life-threatening disease or condition;
- No similar or satisfactory alternative therapy is available;
- It is not possible for the patient to enroll in a clinical trial;
- The HCP treating the patient has determined that the potential benefit of the treatment outweighs the potential risk of the treatment;
- An appropriate access pathway exists based on local regulatory requirements; and
- The investigational drug is available and can be supplied without negative impact to ongoing programs and in a timeframe that will allow for meaningful intervention.
Submitting Requests for Early Access
For early access requests related to our investigational COVID-19 oral antiviral, ensitrelvir (generic name: ensitrelvir fumaric acid, Code No.: S-217622), please see the Ensitrelvir Early Access page.
For early access requests related to Fetroja® (cefiderocol) in Argentina, Canada, Chile, Colombia, Guatemala, Mexico and Panama, please visit Inceptua’s request portal.