Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
AGENCY
HHS-NIH11
PROGRAM
Discretionary
AMOUNT
—
CLOSES
Jul 2, 2027
Description
This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning.
Eligibility
State governments; Public housing authorities/Indian housing authorities; For profit organizations other than small businesses; Others (see text field entitled "Additional Information on Eligibility" for clarification); Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Native American tribal organizations (other than Federally recognized tribal governments); City or township governments; County governments; Private institutions of higher education; Public and State controlled institutions of higher education; Special district governments; Independent school districts; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Small businesses; Native American tribal governments (Federally recognized)
Contact
Additional details
- Funding instrument
- Grant
- Cost sharing required
- No
- Archived
- Aug 1, 2027
Opportunity number: RFA-TR-25-002
Search this number on Grants.gov for the official listing.