Ensitrelvir Expanded Access
Expanded access to our investigational COVID-19 oral antiviral ensitrelvir (generic name: ensitrelvir fumaric acid, Code No.: S-217622) may be provided for qualified patients with SARS-CoV-2 infection when approved therapies or a clinical trial of ensitrelvir are not options.
How To Submit a Request for Expanded Access
- 1If you are a treating physician and believe your patient is eligible for ensitrelvir through expanded access, please submit a request to Shionogi Medical Information via our inquiry form. The request must be submitted by the treating physician on behalf of the patient.
- 2Once we receive and confirm your request, we will send you an initial packet of documentation, including instructions, to initiate the EAP process.
- 3Should Shionogi approve expanded access for a patient, we will send a letter of authorization to you along with additional instructions and the remaining forms and reference materials.