Opportunity Information: Apply for PAR 25 297
The National Institutes of Health (NIH) is offering a cooperative agreement opportunity called the Alzheimer's Drug-Development Program (U01 Clinical Trial Optional), listed as PAR-25-297 (CFDA 93.866). The aim is to move promising, novel therapeutic candidates for Alzheimer's disease (AD) forward through late preclinical work and into early human testing. Specifically, the program supports development of new small-molecule drugs and biologics intended to prevent Alzheimer's, slow or modify disease progression, or treat cognitive and behavioral symptoms associated with the disease. The focus is intentionally practical and milestone-driven, emphasizing the work needed to advance a candidate toward clinical readiness rather than open-ended research.
The funding is designed to cover the types of development activities that typically stand between a strong lead candidate and an Investigational New Drug (IND) application, and in some cases, the first-in-human Phase I study. Supported activities include medicinal chemistry and optimization (for small molecules), pharmacokinetics (PK), and ADMET (absorption, distribution, metabolism, excretion, and toxicology) studies; demonstration of efficacy in appropriate animal models; development of biomarkers specifically aimed at confirming target engagement; formulation development; and chemical synthesis and manufacturing under Good Manufacturing Practices (GMP). The program also supports IND-enabling studies and allows initial Phase I clinical testing, which is why the notice is labeled "Clinical Trial Optional." In other words, applicants can propose a package that ends at IND-enabling work, or one that continues into early Phase I, as long as the overall plan fits the program's drug-development purpose.
Just as important is what the NOFO does not fund. It is not intended for basic science studies on disease mechanisms or broad investigations into how a drug works at a fundamental level. It also excludes efforts focused solely on developing risk, diagnostic, prognostic, predictive, or prevention biomarkers (as standalone biomarker programs), as well as devices and non-pharmacological interventions such as exercise programs, dietary interventions, or cognitive training approaches. Repurposed drugs and combination therapies are considered non-responsive under this announcement, and so are discovery-stage activities like high-throughput screening, hit identification, and early hit-to-lead optimization when the work is still at the discovery stage. Stand-alone clinical trials that are not embedded in a broader preclinical-to-IND-to-Phase-I development pathway are also not a fit. The underlying message is that NIH wants applicants who already have a defined therapeutic candidate and a credible development plan to de-risk it and move it toward early clinical evaluation.
This opportunity uses the U01 mechanism, meaning it is a cooperative agreement rather than a standard grant. In practical terms, a cooperative agreement generally implies substantial involvement from the NIH program team during the project, often through active scientific and programmatic stewardship, alignment to milestones, and ongoing coordination around development decisions. For applicants, that typically means proposing clear deliverables and development checkpoints, and being prepared for a more collaborative, guided form of federal support than a traditional investigator-initiated research award.
Eligibility is broad across the U.S. research and development ecosystem. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The NOFO also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and eligible federal agencies.
On the international side, the rules are specific. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning certain project elements can be performed abroad when appropriately justified and structured under a U.S.-based applicant.
Key administrative details include that the sponsoring agency is NIH, the opportunity category is discretionary, and the instrument type is a cooperative agreement (U01). The original closing date provided is 2027-11-05. The listed award ceiling is $1,500,000, indicating the maximum award amount under the announcement (with actual budgets typically depending on the scope, milestones, and NIH program priorities). Overall, this NOFO is best suited for teams with a novel AD therapeutic candidate that is beyond discovery, ready for rigorous preclinical development and IND-enabling work, and potentially positioned to enter initial Phase I clinical testing within the proposed project period.Apply for PAR 25 297
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)" 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 2024-12-04.
- Applicants must submit their applications by 2027-11-05.
- Each selected applicant is eligible to receive up to $1,500,000.00 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: Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) - PAR-25-297
What is this NIH funding opportunity?
This is an NIH cooperative agreement opportunity called the Alzheimer's Drug-Development Program (U01 Clinical Trial Optional). It is listed as PAR-25-297 (CFDA 93.866) and is designed to support practical, milestone-driven drug development for Alzheimer's disease (AD).
What is the main goal of the program?
The goal is to move promising, novel therapeutic candidates for Alzheimer's disease through late preclinical development and into early human testing. The program is structured to help teams advance a defined candidate toward clinical readiness (including IND-enabling work and, in some cases, initial Phase I testing).
What types of Alzheimer's therapies does the program support?
The program supports development of new small-molecule drugs and biologics intended to prevent Alzheimer's, slow or modify disease progression, or treat cognitive and behavioral symptoms associated with the disease.
Is this program intended for discovery research or basic science?
No. The program is intentionally practical and development-focused. It is not intended for basic science studies of disease mechanisms or broad, open-ended investigations of how a drug works at a fundamental level.
What stage should a project be in to be a good fit?
This NOFO is best suited for teams that already have a defined, novel AD therapeutic candidate that is beyond discovery and ready for rigorous late preclinical development and IND-enabling work, with the potential to move toward initial Phase I clinical testing within the project period.
What development activities can be supported with these funds?
Supported activities include work that commonly sits between a strong lead candidate and an IND application (and potentially first-in-human Phase I). Examples listed in the opportunity include medicinal chemistry/optimization for small molecules, PK and ADMET studies, efficacy studies in appropriate animal models, biomarker development for target engagement, formulation development, GMP chemical synthesis/manufacturing, and IND-enabling studies.
Does the program support medicinal chemistry for small molecules?
Yes. Medicinal chemistry and optimization activities for small-molecule candidates are included among the supported development activities.
Are pharmacokinetics (PK) and ADMET/toxicology studies supported?
Yes. The opportunity specifically calls out pharmacokinetics (PK) and ADMET (absorption, distribution, metabolism, excretion, and toxicology) studies as eligible development activities.
Can applicants include animal efficacy studies?
Yes. Demonstration of efficacy in appropriate animal models is described as a supported activity.
Does the NOFO support biomarker development?
It supports biomarker development specifically aimed at confirming target engagement. However, the opportunity does not support efforts focused solely on developing risk, diagnostic, prognostic, predictive, or prevention biomarkers as standalone biomarker programs.
Are formulation development and GMP manufacturing supported?
Yes. The NOFO includes formulation development and chemical synthesis/manufacturing under Good Manufacturing Practices (GMP) among the supported activities.
Does this program support IND-enabling studies?
Yes. The program supports IND-enabling studies and other late preclinical work designed to advance a candidate toward an Investigational New Drug (IND) application.
Are clinical trials required under this announcement?
No. The NOFO is labeled "Clinical Trial Optional," meaning applicants can propose a package that ends at IND-enabling work or one that continues into early Phase I clinical testing, as long as the overall plan aligns with the program's drug-development purpose.
What does "Clinical Trial Optional" mean in practical terms?
It means a clinical trial is allowed but not mandatory. A project may stop at IND-enabling activities or extend into a first-in-human Phase I study, provided the project is part of a broader preclinical-to-IND-to-Phase-I development pathway.
Does the program fund standalone clinical trials?
No. Stand-alone clinical trials that are not embedded in a broader preclinical-to-IND-to-Phase-I development pathway are described as not a good fit for this announcement.
What types of projects are explicitly not supported?
The NOFO is not intended to fund: basic science studies on disease mechanisms; broad fundamental studies of drug mechanism; standalone biomarker programs focused only on risk/diagnostic/prognostic/predictive/prevention biomarkers; devices; non-pharmacological interventions (such as exercise, dietary interventions, or cognitive training approaches); repurposed drugs; combination therapies; and discovery-stage activities such as high-throughput screening, hit identification, and early hit-to-lead optimization when the work is still at the discovery stage.
Are drug repurposing projects eligible?
No. Repurposed drugs are considered non-responsive under this announcement based on the provided description.
Are combination therapies eligible?
No. Combination therapies are described as non-responsive under this announcement.
Does the program support high-throughput screening or hit identification?
No. Discovery-stage activities, including high-throughput screening, hit identification, and early hit-to-lead optimization (when still at the discovery stage), are described as not a fit for this NOFO.
Are devices or non-drug interventions allowed?
No. Devices and non-pharmacological interventions (including exercise programs, dietary interventions, or cognitive training approaches) are excluded based on the information provided.
What funding mechanism is used?
The opportunity uses the U01 mechanism, which is a cooperative agreement rather than a standard grant.
What does a U01 cooperative agreement imply for the project?
A cooperative agreement generally implies substantial NIH program involvement during the project. The description emphasizes active scientific and programmatic stewardship, alignment to milestones, and ongoing coordination around development decisions, which typically means applicants should propose clear deliverables and development checkpoints.
Who is eligible to apply?
Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The NOFO also highlights eligible categories such as HBCUs, Hispanic-serving institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, and eligible federal agencies.
Can for-profit organizations apply?
Yes. For-profit organizations (including those other than small businesses) are listed as eligible applicants.
Are small businesses eligible?
Yes. Small businesses are included among eligible applicants.
Are non-U.S. (foreign) organizations eligible to apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization.
Can a U.S. applicant include foreign components in the project?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement. This means certain project elements can be performed abroad when appropriately justified and structured under a U.S.-based applicant.
Which agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the opportunity category and instrument type?
The opportunity category is discretionary, and the instrument type is a cooperative agreement (U01).
What is the closing date listed for this opportunity?
The original closing date provided is 2027-11-05.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $1,500,000. Actual budgets are typically dependent on the proposed scope, milestones, and NIH program priorities as described in the opportunity summary.
How should applicants think about milestones and deliverables?
The program is described as milestone-driven and focused on practical development work. Applicants should be prepared to propose clear deliverables and development checkpoints consistent with advancing a therapeutic candidate toward IND readiness and potentially early Phase I testing.
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