NIH PAR · NCATS · R21

PAR-25-450: Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

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

Open for applicationsNext due date: Feb 17, 2027Expires Jul 21, 2028

This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

Full NOFO in the NIH Guide Apply on Grants.gov

NOFO number
PAR-25-450
Type
PAR
Activity code
R21
Primary institute
NCATS · National Center for Advancing Translational Sciences
Clinical trials
Not Allowed
Posted
Sep 22, 2025
Opens
Jan 17, 2026
Expires
Jul 21, 2028

PAR-25-450 due dates

4 application due dates remain before the NOFO expires. Dates marked * are NIH standard due dates. Check the related notices below for changes NIH made after posting.

Application due dates and review cycles for PAR-25-450
Application Due Date(s)Renewal / Resubmission / Revision (as allowed)AIDS - New/Renewal/Resubmission/Revision, as allowedScientific Merit ReviewAdvisory Council ReviewEarliest Start Date
February 18, 2026March 17, 2026Not ApplicableJuly 2026October 2026December 2026
June 17, 2026July 17, 2026Not ApplicableOctober 2026January 2027April 2027
February 17, 2027March 17, 2027Not ApplicableJuly 2027October 2027December 2027
June 17, 2027July 19, 2027Not ApplicableOctober 2027January 2028April 2028
February 17, 2028March 17, 2028Not ApplicableJuly 2028October 2028December 2028
June 20, 2028July 20, 2028Not ApplicableOctober 2028January 2029April 2029

What its predecessor PAR-23-159 funded

PAR-25-450 reissues PAR-23-159. Until awards appear under the new number, its funding history is the best guide to who wins under this program: 10 projects and $4.1M in FY2022–FY2026.

Projects funded

10

Distinct projects, FY2022–FY2026

New awards

10

Type 1 (new project) award records

NIH funding

$4.1M

Award dollars under PAR-23-159, FY2022–FY2026

Funding by fiscal year

Award records, new awards, and funding by fiscal year under PAR-23-159
Fiscal yearAward recordsNew awardsFunding
FY202200$0
FY202300$0
FY202444$1.4M
FY202576$2.7M
FY202600$0

Institutions with the most funding

  1. Duke University$456K · 1 project
  2. University of Pennsylvania$402K · 1 project
  3. Myogene Bio, LLC$303K · 1 project
  4. Greenstone Biosciences, Inc.$303K · 1 project

Funding institutes

  • NCATS$3.4M · 9
  • NICHD$718K · 2

Activity codes funded

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 PAR-25-450. Contact the program officer at the institute that fits your research before applying.

  • NCATS · National Center for Advancing Translational Sciences
  • NICHD · Eunice Kennedy Shriver National Institute of Child Health and Human Development

Related notices

  1. 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.

  2. 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 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
Applications can request budgets that are up to 275,000 direct costs for the 2-year project period of the award. No more than 200,000 direct costs may be requested in any single year.
Project period
The scope of the proposed project should determine the project period. The maximum project period is 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 number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

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

Related NOFOs

  • Reissue of PAR-23-159.

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