EXPANDED ACCESS
one FDA-authorized pathway
Hope Biosciences is proud to make our investigational products available for among the most comprehensive Expanded Access research suites in cellular therapeutics in the United States.
Expanded Access, also known as “Compassionate Use,” is an FDA-authorized pipeline designed to extend access to promising investigational therapeutics to individuals who do not qualify for participation in larger clinical trials due to disease complexity, level of disease progression, age, physical inability to travel to a clinical trial site due to disease burden, or similar considerations, and when no comparable or satisfactory alternative therapy options are available. Expanded Access protocols can be designed for individual patients, or for “Intermediate Size” patient groups smaller than the volume typical of a clinical trial. Expanded Access protocols uphold the same safety, reporting, and regulatory standards as larger clinical trials.
The 21st Century Cures Act requires companies developing investigational drugs to make policies regarding evaluation of and response to requests for Expanded Access publicly and readily available.
Hope Biosciences currently executes Expanded Access protocols through the Hope Biosciences Research Foundation (HBRF).
HBRF manages the Expanded Access process, including response to inquiries. To begin, please contact HBRF by calling (346)900-0340, writing to clinical@hopebio.org, or through the submission form on their website. Once HBRF receives your request, they will work directly with you to complete your Expanded Access application, including receipt and screening of medical records. Expanded Access requests are prioritized based on an algorithm that considers, among other factors, severity of condition and impact on quality of life, and that prioritizes pediatric patients, U.S. residents, and military servicemembers.
There is no treatment cost associated with participation in Expanded Access. As of 2026, average wait time to receive treatment through Expanded Access is approximately 3-4 years.