Early 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 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 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.

  • Ensitrelvir

    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.

    Ensitrelvir Early Access

  • Fetroja

    For early access requests related to Fetroja® (cefiderocol) in Argentina, Canada, Chile, Colombia, Guatemala, Mexico and Panama, please visit Inceptua’s request portal.

    Fetroja Early Access
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.

Zatolmilast 

At this time, we are not able to offer Early Access for zatolmilast, an investigational drug being studied for Fragile X syndrome. We believe it is in the best interest of patients to make zatolmilast available only through clinical trials. As such, Early Access requests will be referred to study investigators to determine whether a patient is eligible for an ongoing clinical trial. As additional studies are completed for this investigational drug, we may revisit this policy.

 S-337395

At this time, we are not able to offer Early Access for our investigational RNA-dependent RNA polymerase inhibitor (S-337395) being studied for respiratory syncytial virus. As this investigational drug is in an early stage of development, we believe it is in the best interest of patients to make it available only through clinical trials. As such, any Early Access requests will be referred to study investigators to determine whether a patient is eligible for an ongoing clinical trial. As additional studies are completed for this investigational drug, we may revisit this policy.  

S-892216 Long-Acting Injectable

At this time, we are not able to offer Early Access for our investigational drug S-892216 long-acting injectable, which is a long-acting Mpro inhibitor of SARS-CoV-2 being studied for the pre-exposure prophylaxis (PrEP) of COVID-19. As this investigational drug is in an early stage of development, more information is needed to define the optimal utility of this drug. As additional studies are completed for this investigational drug, we may revisit this policy.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.