NIH RFA · NCATS · R21

RFA-TR-25-002: Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)

Reviewed by Dr. Meng ZhaoLast reviewed October 16, 2026Data refreshed October 16, 2026Editorial standards

Open for applicationsExpires Jun 3, 2027

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…

Full NOFO in the NIH Guide Apply on Grants.gov

NOFO number
RFA-TR-25-002
Type
RFA
Activity code
R21
Primary institute
NCATS · National Center for Advancing Translational Sciences
Clinical trials
Not Allowed
Posted
Dec 6, 2024
Opens
May 2, 2025
Expires
Jun 3, 2027

Projects funded under RFA-TR-25-002

NIH RePORTER lists 8 projects funded under RFA-TR-25-002 in FY2022–FY2026, with $3.6M in award dollars. Counts include each project's later non-competing years, which keep the original NOFO number.

Projects funded

8

Distinct projects, FY2022–FY2026

New awards

8

Type 1 (new project) award records

NIH funding

$3.6M

Award dollars under RFA-TR-25-002, FY2022–FY2026

Funding by fiscal year

Award records, new awards, and funding by fiscal year under RFA-TR-25-002
Fiscal yearAward recordsNew awardsFunding
FY202200$0
FY202300$0
FY202400$0
FY202500$0
FY202688$3.6M

Institutions with the most funding

  1. Icahn School of Medicine at Mount Sinai$462K · 1 project
  2. UT Southwestern Medical Center$457K · 1 project
  3. Columbia University Health Sciences$451K · 1 project
  4. Children's Mercy Hosp (Kansas City, Mo)$450K · 1 project
  5. Oregon Health & Science University$448K · 1 project
  6. University of Minnesota$440K · 1 project
  7. Stanford University$427K · 1 project
  8. University of Georgia$415K · 1 project

Funding institutes

  • NCATS$3.6M · 8

Activity codes funded

Most recent new awards

What its predecessor RFA-TR-24-023 funded

RFA-TR-25-002 reissues RFA-TR-24-023. Its funding history is the best guide to who wins under this program: 6 projects and $2.6M in FY2022–FY2026.

Projects funded

6

Distinct projects, FY2022–FY2026

New awards

6

Type 1 (new project) award records

NIH funding

$2.6M

Award dollars under RFA-TR-24-023, FY2022–FY2026

Funding by fiscal year

Award records, new awards, and funding by fiscal year under RFA-TR-24-023
Fiscal yearAward recordsNew awardsFunding
FY202200$0
FY202300$0
FY202400$0
FY202566$2.6M
FY202600$0

Institutions with the most funding

  1. Children's Hosp of Philadelphia$490K · 1 project
  2. Northwestern University$440K · 1 project
  3. Stanford University$427K · 1 project
  4. Clemson University$419K · 1 project
  5. University of Florida$419K · 1 project
  6. Nostopharma, LLC$408K · 1 project

Funding institutes

  • NCATS$2.6M · 6

Activity codes funded

Most recent new awards

FY2026 closed on September 30, 2026, but NIH keeps posting that year's awards to RePORTER for several weeks. FY2026 figures reflect records available on October 16, 2026 and may rise slightly at the next refresh.

Participating institutes

2 NIH institutes and offices take applications under RFA-TR-25-002. Contact the program officer at the institute that fits your research before applying.

  • NCATS · National Center for Advancing Translational Sciences
  • none

Related notices

  1. Mar 31, 2025 · NOT-OD-24-084

    This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25,…

  2. Aug 31, 2022 · NOT-OD-22-198

    Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.

  3. Aug 5, 2022 · NOT-OD-22-189

    Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Award terms

Application types allowed
NewResubmission - Resubmission of Applications submitted to RFA-TR-23-016, RFA-TR-24-023 and this NOFO The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Award budget
The combined budget for direct costs for the two-year project period may not exceed 275,000. No more than 200,000 may be requested in any single year. 
Project period
The total project period may not exceed 2 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Funds available and number of awards
The NIH intends to commit up to 1,200,000 in FY26, contingent upon receiving scientifically meritorious applications. 3-5 awards are anticipated from this solicitation. Future year amounts will depend on annual appropriations. 

Summarized from the NOFO text; the full NOFO governs eligibility, budget, and review.

Related NOFOs

  • Reissue of RFA-TR-24-023.

Other open NOFOs for R21

Browse all open NIH NOFOs

About this page

GotGrant gathers the NOFO, its participation and change notices, and its NOSIs from the NIH Guide for Grants and Contracts, and counts funded projects from NIH RePORTER by the opportunity number each award was made under. Data refreshed October 16, 2026; the NIH Guide is the authoritative source. See our data methodology.

Find who wins under this NOFO

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