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Orphan Products Clinical Trials Grants Program

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases

Funds clinical research for rare disease products by supporting trial design and study execution.

Between cyclesFDA Office of Orphan Products DevelopmentUnited States

The FDA Office of Orphan Products Development (OOPD) Clinical Trials Grants Program, established under the Orphan Drug Act of 1983, funds clinical trials of drugs, biologics, medical devices, and foods for medical purposes indicated for rare diseases or conditions affecting fewer than 200,000 people in the United States. Diagnostics and vaccines qualify only if the U.S. population to whom they wil…

Clinical trials evaluating safety or efficacy of drugs, biologics, medical devices, or foods for medical purposes intended for rare diseases or conditions affecting fewer than 200,000 people in the United States.

CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.Annual
Next deadlineiThe next date applications are due. Rolling means you can apply any time.20 Oct 2026
Decision timeiTypical time from the deadline to the funder's decision.—
Project durationiHow long the funded work is expected to run.—
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Grant
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.0%
Funding pooliThe total budget available across all awards in this round.$5M

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Last verified: 22 Jul 2026Source: www.fda.gov