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

  1. 1
    If 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.
  2. 2
    Once we receive and confirm your request, we will send you an initial packet of documentation, including instructions, to initiate the EAP process.
  3. 3
    Should 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.
Shionogi does not guarantee it can or will approve access to 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