Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Posted by National Institutes of Health
Opportunity snapshot. This Grants.gov announcement — Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed) — is cataloged under number RFA-TR-25-002 and tied to CFDA assistance listing 93.350, posted by National Institutes of Health. Grants.gov currently shows the opportunity as open, first posted on December 6, 2024. The funding category is Discretionary, delivered as a grant.
Award economics. The award range on file is Varies by applicant. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. Applications close on June 2, 2026. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully — federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed — it helps clarify scope and scoring priorities.
Award Range
Varies by applicant
Close Date
June 2, 2026
Posted
December 6, 2024
Instrument
Grant
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
00;01;02;04;05;06;07;08;11;12;13;20;22;23;25
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Mental Health National Research Service Awards
National Institutes of Health
Agency Contact
NIH Grants Information<br/>grantsinfo@nih.gov
Key Dates
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Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
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| Publisher | Kiznis Studio |
| Sources | Public official public datasets |