Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Food and Drug Administration · Other Federal · FOR-FD-25-020

Source: Grants.gov · View original posting ↗

AwardWhat a single award can be worth — the funder's published per-award amount or floor–ceiling range.

Amount not listed

DeadlineFinal application due date.

Not yet posted

Letter of intentDue date for the letter of intent (a short pre-application some funders require or request before the full proposal).

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MechanismNIH activity code — the grant type (R01 research project, R21 exploratory, K series career development, F series fellowship, …).

R01

DurationMaximum project period for a single award.

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Expected awardsHow many awards the funder anticipates making under this opportunity.

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Funding cycleHow often the program accepts applications (annual, multiple cycles per year, rolling, or one-time).

Unknown

Open dateWhen applications open (or opened).

Jul 11, 2025

Total fundingThe overall pool the funder expects to commit across ALL awards under this opportunity — not what one project receives.

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Clinical trialWhether proposed projects must, may, or must not include a clinical trial.

Required