Policy on Expanded Access to Investigational Medicine in the U.S.
Chugai Pharmaceutical Co., Ltd. is a research and development-oriented pharmaceutical company with unique technology and science as its strengths. We dedicate ourselves to adding value by creating and delivering innovative products and services for the medical community and human health around the world. “Patient Centric” is one of Chugai’s core values, and we make each patient’s well-being our highest priority.
Based on this mission and our core values, Chugai strives to develop investigational medicines in compliance with the laws and regulations of each country and region. In the standard drug development process, participating in clinical trials is considered the best approach for ensuring patient safety.
Expanded Access Policy
Chugai understands that patients and physicians may be interested in accessing investigational medicines prior to regulatory approval. At this time, however, Chugai does not offer expanded access to investigational medicines outside of our clinical trials. Chugai’s investigational medicines being developed in the U.S. are in the early stages of clinical development, therefore their potential risks and benefits to patients, as well as appropriate dosing, have not yet been sufficiently established.
We believe that the most appropriate and safest way for patients to access our investigational medicines at this stage is through clinical trial participation. This approach ensures that patients are closely monitored by medical experts and that the data collected in such clinical trials can be used to support regulatory approvals, ultimately providing broad access to new therapies.
Additional information about Chugai’s ongoing clinical trials in the U.S. is available on the NIH’s ClinicalTrials.gov website. (Open in a new window)
Chugai may revise this Expanded Access Policy considering data obtained from clinical trials at any time in the future, and will update this posting accordingly.
Inquiries
If you have any inquiries about our Clinical trials and Expanded Access, please contact.
We will acknowledge receipt of any inquiry within five (5) business days.