Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
Open Posted
- Opportunity number
- PAR-25-297
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $1,500,000
Opportunity facts
- Assistance listings
-
- 93.866 Aging Research
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Higher Education Inst. (Public)
- Public or Indian Housing Auth.
- Other
- 501(c)(3) Nonprofits
- Small Businesses
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Private)
- County Governments
- Tribal Governments (Federally Recognized)
- Non-501(c)(3) Nonprofits
- For Profit Organizations
- Special District Governments
- Independent School Districts
- State Governments
- City/Township Governments
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health seeks applicants for the Alzheimer's Drug-Development Program (U01 Clinical Trial Optional), a cooperative agreement funding pre-clinical and early-stage clinical development of novel small-molecule and biologic drug candidates, with applications due November 5, 2027.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, state and local governments, tribal organizations (federally and non-federally recognized), county and city governments, special district governments, independent school districts, and public or Indian housing authorities. Applicants also include HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, TCCUs, faith-based and community-based organizations, eligible federal agencies, regional organizations, U.S. territories, and non-domestic components of U.S. organizations. Non-domestic entities are not eligible to apply, though foreign components as defined in the NIH Grants Policy Statement are allowed.
Funded activities encompass medicinal chemistry, pharmacokinetics, ADMET studies, efficacy testing in animal models, biomarker development for target engagement, formulation development, GMP chemical synthesis, IND-enabling studies, and Phase I clinical testing. Excluded activities include basic disease mechanism research, biomarker discovery and development, devices, non-pharmacological interventions, repurposed drugs and combination therapies, high-throughput screening and hit optimization, and stand-alone clinical trials.
The program falls under Assistance Listing 93.866 (Aging Research) administered by the National Institute on Aging. Award amounts, expected number of awards, period of performance, and cost-share requirements are not specified in the source material.
Synopsis
The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials.
Eligibility
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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-297-Full-Announcement.html | HTML file | |
| PKG00289419.pdf |
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