Ensitrelvir Early Access
Early access to our investigational COVID-19 oral antiviral, ensitrelvir (generic name: ensitrelvir fumaric acid, Code No.: S-217622) for the treatment of COVID-19 may be provided for qualified patients with SARS-CoV-2 infection when approved therapies or a clinical trial of ensitrelvir are not options. Shionogi is not providing early access for ensitrelvir for post-exposure prophylaxis.
How To Submit a Request for Early Access
- 1If you are a treating physician and believe your patient is eligible for ensitrelvir for the treatment of COVID-19 through early 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 access for a patient, we will send a letter of authorization to you along with additional instructions and the remaining forms and reference materials.
Shionogi does not guarantee it can or will approve access to an investigational drug based on your request. Shionogi may require up to five (5) business days to review an EAP request.
Shionogi Medical Information
Tel: + 1 (800) 849-9707, 9 a.m. to 5 p.m. ET
Email: medinfo@shionogi.com