Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
About
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.
The Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) is a federal funding opportunity designed for researchers and organizations developing innovative treatments for Alzheimer's disease. This Notice of Funding Opportunity (NOFO) supports pre-clinical and early-stage clinical development of novel small-molecule and biologic drug candidates that prevent AD, slow its progression, or address cognitive and behavioral symptoms. Eligible applicants include academic institutions, faith-based organizations, community-based organizations, HBCUs, Hispanic-serving institutions, and tribal governments. Funding covers critical drug development activities including medicinal chemistry, pharmacokinetics, ADMET studies, animal model efficacy testing, biomarker development, GMP chemical synthesis, IND-enabling studies, and Phase I clinical testing. This is an ideal opportunity for researchers positioned to move promising Alzheimer's therapies from laboratory discovery toward human trials. Organizations with strong pre-clinical data and a clear development pathway should consider applying to accelerate their drug candidates toward clinical viability and potential FDA approval.
Funding Facts
● Applications openDeadline
November 5, 2027
Award Amount
Up to $1.5M
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Grant Amount
Up to $1.5M
Deadline
2027-11-05
Grant Type
federal
Application Cycle
Annual (Deadline: November 5, 2027)
Best For
Academic institutions, HBCUs, Hispanic-serving institutions, minority-serving institutions, and community-based organizations developing novel Alzheimer's disease therapeutics
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 Govern
Frequently Asked Questions
Who is eligible for Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)?
Eligible applicants include 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, and Historically Black Colleges and Universities (HBCUs). Indian/Native American Tribal Government entities are also eligible. For a complete and current list of eligible applicants, please visit the official NIH funding opportunity announcement.
How much funding does Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) provide?
Funding ranges from no specific minimum up to $1,500,000 per award. The actual amount awarded may vary based on the scope of the proposed research, project requirements, and available funding. Contact the NIH directly or review the official NOFO for specific details about funding levels for your application cycle.
How do I apply for Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)?
Applications must be submitted through the official NIH grants submission portal. The application deadline is November 5, 2027. You will need to prepare a detailed research proposal, budget justification, timeline, and supporting documentation. Visit the NIH website for the complete Notice of Funding Opportunity, detailed instructions, and submission guidelines for this specific program.
What can Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) funding be used for?
Funding supports therapy development activities including medicinal chemistry, pharmacokinetics (PK), ADMET studies, efficacy testing in animal models, biomarker development for target engagement, formulation development, GMP chemical synthesis, Investigational New Drug (IND) enabling studies, and initial Phase I clinical testing. Applications focused on basic disease mechanisms, diagnostic biomarkers, devices, non-pharmacological interventions, repurposed drugs, combination therapies, or stand-alone clinical trials are not responsive to this NOFO.
Last updated: July 5, 2026