Opportunity Information: Apply for PAR 25 374
The National Institutes of Health (NIH) is soliciting R01 grant applications under Funding Opportunity Number PAR-25-374, titled "Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed)." The focus of this opportunity is on accelerating practical treatment and prevention strategies for Alzheimers disease and related dementias (AD/ADRD) by supporting rigorous preclinical studies that can generate strong proof-of-concept evidence for moving therapies forward. As an R01 mechanism, the intent is to fund substantial, hypothesis-driven research projects, but it explicitly does not allow clinical trials, keeping the work in the preclinical translational space rather than human interventional testing.
At the core of the NOFO is the expectation that applicants will use mouse models to evaluate drug repositioning and combination therapy approaches. In practical terms, this means testing medicines that are already approved or commonly used for other diseases, as well as investigational agents that are somewhere along the clinical development pipeline for non-AD indications, when there is credible rationale or predictive evidence suggesting potential benefit in AD/ADRD. The program is looking for projects that do more than exploratory screening; it emphasizes rigorous preclinical testing designed to yield interpretable, reproducible results that can support next-step decisions about advancing a candidate toward clinical development in dementia. The overarching goal is to create robust translational outcomes, meaning findings that are directly useful for rationally selecting repurposed drugs, deciding which combinations are worth pursuing, and identifying strategies that plausibly translate into human studies later.
A notable feature of the opportunity is its encouragement of combination approaches, including both drug-drug combinations and drug plus non-pharmacologic interventions. Applications may propose to test repurposable or investigational drug candidates alongside non-pharmacologic strategies, with the idea that multimodal approaches could produce stronger or more durable effects than any single intervention alone. The program frames these studies as a path toward combination therapy development for AD/ADRD, which implies careful attention to how interventions might interact, how outcomes will be measured, and how the work will support a clear translational narrative rather than remaining purely mechanistic.
The funding opportunity sits within NIH's health research portfolio and is associated with CFDA number 93.866. The listed award ceiling is $1,000,000, indicating an upper limit on budget levels under this announcement. The original closing date is May 7, 2028, reflecting a multi-year application window. While the announcement notes "ExpectedAwards:" without a number provided in the supplied text, the key takeaway is that it is an active discretionary grant opportunity with a defined maximum award amount and a long submission horizon, which can be helpful for teams planning extensive preclinical programs or assembling multi-institution collaborations.
Eligibility is broad and includes many types of U.S. organizations and governmental entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The NOFO also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISI), faith-based or community-based organizations, eligible federal government agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth signals NIH's intent to attract a wide range of scientific and translational expertise, including from institutions serving underrepresented populations and from international partners where appropriate.
In short, PAR-25-374 is designed to push AD/ADRD therapy development forward by funding well-controlled, mouse-model-based preclinical studies that test repurposed or investigational drugs, including combination regimens and combinations with non-pharmacologic interventions. The expected output is strong proof-of-concept evidence that can guide rational decisions about which agents and combinations should advance toward later-stage development, while staying clearly outside the scope of clinical trials.Apply for PAR 25 374
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
- This funding opportunity was created on 2024-12-30.
- Applicants must submit their applications by 2028-05-07.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIH PAR-25-374 (R01) - Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias
What is the funding opportunity number and title?
The opportunity is NIH Funding Opportunity Number PAR-25-374, titled "Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed)."
Which NIH grant mechanism is being solicited?
This announcement solicits R01 grant applications, which are intended to support substantial, hypothesis-driven research projects.
Are clinical trials allowed under this funding opportunity?
No. The NOFO explicitly states "Clinical Trial Not Allowed," meaning human interventional clinical trials are outside the scope of this opportunity.
What is the main scientific focus of this opportunity?
The focus is to accelerate practical treatment and prevention strategies for Alzheimers disease and related dementias (AD/ADRD) by supporting rigorous preclinical studies that generate strong proof-of-concept evidence to move therapies forward.
What type of evidence is NIH looking for from funded projects?
NIH is looking for strong, interpretable, reproducible proof-of-concept evidence from rigorous preclinical testing that can support next-step decisions about advancing candidates toward clinical development in dementia.
What experimental models are expected to be used?
The NOFO expects applicants to use mouse models to evaluate drug repositioning and combination therapy approaches for AD/ADRD.
Does the program support exploratory screening studies?
The emphasis is on rigorous preclinical testing rather than exploratory screening, with the goal of producing results that are directly useful for translational decisions.
What does "drug repositioning" mean in the context of this NOFO?
In this NOFO, drug repositioning refers to testing medicines that are already approved or commonly used for other diseases, as well as investigational agents in the clinical development pipeline for non-AD indications, when there is credible rationale or predictive evidence suggesting potential benefit in AD/ADRD.
Can investigational agents be included, or only approved drugs?
Both can be included. The opportunity supports testing of repurposable approved or commonly used medicines and investigational agents that are in development for non-AD indications, provided there is credible rationale or predictive evidence for potential benefit in AD/ADRD.
Are combination therapy projects encouraged?
Yes. The NOFO encourages combination approaches, including drug-drug combinations and drug plus non-pharmacologic interventions.
Can a project combine a drug with a non-pharmacologic intervention?
Yes. Applications may propose testing repurposable or investigational drug candidates alongside non-pharmacologic strategies as part of a multimodal approach.
What is the translational goal of studying combinations?
The translational intent is to determine which combinations are worth pursuing and to build a clear narrative for advancing candidates and regimens toward later-stage development, while remaining in the preclinical translational space.
Is the opportunity limited to mechanistic studies?
The program emphasizes translational outcomes and proof-of-concept evidence that can guide therapy advancement decisions, rather than remaining purely mechanistic.
What is the award ceiling for this announcement?
The listed award ceiling is $1,000,000, indicating an upper limit on budget levels under this announcement.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.866.
What is the closing date for the opportunity?
The original closing date listed is May 7, 2028.
Is the number of expected awards specified?
In the provided information, the announcement notes "ExpectedAwards:" but does not provide a number.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. organizations and governmental entities, as well as non-U.S. entities (foreign organizations).
Which U.S. governmental entities are eligible?
Eligible applicants include state governments, county governments, city or township governments, and special district governments.
Are educational institutions eligible?
Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.
Are tribal entities eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and other Native American tribal organizations.
Are housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Are nonprofit organizations eligible?
Yes. Nonprofits with and without 501(c)(3) status (other than institutions of higher education) are eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are eligible, and small businesses are also eligible.
Are institutions that serve specific communities highlighted as eligible?
Yes. The NOFO highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Asian American Native American Pacific Islander Serving Institutions (AANAPISI).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are listed among the highlighted eligible applicant categories.
Are federal agencies eligible to apply?
Yes. Eligible federal government agencies are included among the highlighted eligible applicant categories.
Are U.S. territories eligible?
Yes. U.S. territories or possessions are listed among the highlighted eligible applicant categories.
Are foreign organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are explicitly included in the eligibility description provided.
What kinds of outcomes should a successful project produce?
The expected outcomes include robust translational findings that help rationally select repurposed drugs, decide which combinations merit further pursuit, and identify strategies that plausibly translate into human studies later, without conducting clinical trials under this award.
What disease area does this opportunity target?
This opportunity targets Alzheimers disease and related dementias (AD/ADRD).
What is the overall purpose of PAR-25-374 in one sentence?
PAR-25-374 aims to push AD/ADRD therapy development forward by funding well-controlled, mouse-model-based preclinical studies testing repurposed or investigational drugs, including combination regimens and combinations with non-pharmacologic interventions, to generate strong proof-of-concept evidence for next-step development decisions.
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