Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Funds clinical trials testing new or existing treatments to improve care and expand approved uses for rare diseases with unmet medical needs.
Funder: Food and Drug Administration (FDA)
Due Dates: Projected: July 2025 (anticipated annual cycle)
Funding Amounts: Funding amounts vary; typical R01 awards support multi-year clinical trials.
Summary: Supports clinical trials evaluating efficacy and/or safety of products to address unmet needs in rare diseases or conditions.
Key Information: Forecasted opportunity; all dates and details subject to update.
Description
This grant opportunity supports clinical trials of products aimed at evaluating efficacy and/or safety for new indications or label changes to address unmet needs in rare diseases or conditions. The FDA seeks to fund collaborative, efficient, and innovative clinical trials that will increase the number of approved treatments for rare diseases and have a broad, positive impact on rare disease drug development.
