National Institutes of Health · United States

Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)

Open

Applications close on 2 Jul 2027. Eligible applicant types include city or township governments, small businesses, nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education and 12 more.

Deadline: 2 Jul 2027 (in 229 days)
Grant amount: Not stated — see the official call
Funding rate: No mandatory cost sharing stated; funding percentage not stated
Cost sharing: Not required
Likely applicant types: Public bodies, SMEs / start-ups, Companies, Non-profits, Universities & research From source categories or programme rules; the call decides.
Funder: National Institutes of Health
Reference: RFA-TR-25-002
Assistance listing: 93.350 National Center for Advancing Translational Sciences
Last checked: 13 Nov 2026

Open the official call ↗ Add deadline to calendar

About this call

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.

Who can apply

City or township governments
Small businesses
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
State governments
County governments
Special district governments
For profit organizations other than small businesses
Public and State controlled institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Native American tribal governments (Federally recognized)
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant categories are a starting point. The official call decides eligibility.

Topics

Health

How to apply

Read the full notice of funding opportunity (NOFO) linked from the official page: eligibility, cost sharing and evaluation criteria.
Make sure your organisation has an active SAM.gov registration and Unique Entity ID (UEI); registration can take several weeks.
For NIH: the organisation and the principal investigator also need eRA Commons accounts; applications are usually submitted through Grants.gov (for example with ASSIST).
Prepare the required forms, narrative, budget and attachments exactly as the NOFO specifies.
Submit before the deadline and keep the tracking number. Check for amendments before you submit.

From the call text

Who can apply: Not stated in the call text we hold — check the official page
Company stage: Not stated in the call text we hold — check the official page
Single applicant or consortium: Not stated in the call text we hold — check the official page
Where applicants must be based: Not stated in the call text we hold — check the official page
Where to apply: Not stated in the call text we hold — check the official page

Contact

National Institutes of Health · grantsinfo@nih.gov · 301-402-2541

Where these facts come from

Fact	Value	How we know	Taken from the source
Deadline	2 July 2027	official data field	15 Nov 2026
Amount per applicant	Unknown — not stated in the source we hold	unknown	—
Total budget	Unknown — not stated in the source we hold	unknown	—
Funding rate	No mandatory cost sharing stated; funding percentage not stated	read from the official text	15 Nov 2026
Who can apply	City or township governments; Small businesses; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Private institutions of higher education; State governments; County…	official data field	15 Nov 2026
Where to apply	Unknown — not stated in the source we hold	unknown	—

Official sources

Official call page · Funder's programme page

Facts on this page come from the funder’s official data, taken on 13 Nov 2026. The funder's own documents, including later amendments, always take precedence.