Expanded Access Policy
Shionogi Clinical Trials
Shionogi & Co., Ltd. and its subsidiary companies, including Shionogi Inc. in the U.S. (Shionogi), are committed to developing safe and effective medicines and treatments for patients worldwide through clinical trials of unlicensed medicinal products (investigational drugs). The clinical trials are designed to evaluate whether such investigational drugs are safe and effective for treating a specific disease or condition before seeking regulatory approval to market the drugs.
Shionogi encourages patients and their healthcare providers to learn more about Shionogi’s clinical trial programs here.
Shionogi Expanded Access
In addition, through its Expanded Access Programs (EAPs) (also known as compassionate use, managed access, special access, early 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:
Expanded 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 Expanded Access
For general questions about Shionogi’s EAP programs, or if a treating HCP believes a patient may meet the above criteria and is eligible for one of Shionogi’s EAP programs, the HCP can submit a request to Shionogi Medical Information or call Shionogi Medical Information at +1 (800) 849-9707 between 9 a.m. and 5 p.m. ET.
For expanded access requests related to our investigational COVID-19 oral antiviral ensitrelvir (generic name: ensitrelvir fumaric acid, Code No.: S-217622) please see the Ensitrelvir Expanded Access page.
Upon receipt of a request from an HCP related to an EAP for a patient, a representative from Shionogi Medical Information will confirm the request and will provide the HCP with an initial packet of documentation to complete to initiate the EAP process.
Shionogi does not guarantee it can or will approve access to investigational drugs pursuant to the request, as it must evaluate several factors such as the total amount of available investigational drugs stocked.
Shionogi may require up to five (5) business days to acknowledge and/or review an EAP request.