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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases

Funds foreign and domestic entities running rare-disease clinical trials through FDA orphan products research grants.

The Food and Drug Administration administers this grant through the Office of Orphan Products Development rare disease research grant programs. The R01 notice funds clinical trials of orphan products that evaluate efficacy or safety for a new indication or labeling change addressing unmet needs in rare diseases or conditions.

Foreign or domestic public or private for-profit and nonprofit entities

Clinical trials evaluating efficacy or safety of medical products for new indications or labeling changes addressing unmet needs in rare diseases.

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.

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Last verified: 5 Aug 2026Source: www.fda.gov