GOV — GOVERNMENT

FDA Orphan Products Grants — Clinical Trials (RFA-FD-25-020)

FDA Office of Orphan Products Development

Award

Up to $650K/yr × 4 yrs ($900K/yr for innovative designs)

Deadline

Receipt dates Oct 20, 2026 and Oct 19, 2027

Award type

Cash grant

Focus

Clinical research

Funds phase 1–3 clinical trials of drugs, biologics, devices, or medical foods for rare diseases, supporting new indications or labeling changes.

Why it's in this index

BTHS trials are within scope, including follow-ons to elamipretide-class programs or gene therapy. FDA has previously funded BTHS-relevant orphan trials.

Who can apply

Domestic and foreign applicants, academic or industry — any organization able to conduct the trial (the product must not yet be approved for the indication).

How to apply

NIH-style R01 application to FDA via Grants.gov / eRA Commons. Next receipt date Oct 20, 2026.

Links & downloads

RFA-FD-25-020 ↗FDA rare disease programs ↗