Opportunity Information: Apply for PAR 18 820
The Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional), listed as NIH Funding Opportunity PAR-18-820 (CFDA 93.866), is a discretionary health funding opportunity that uses a cooperative agreement mechanism (U01). The core purpose of the program is to move promising, novel Alzheimer’s disease therapeutics through the practical, product-focused steps needed to reach the clinic, with support spanning late preclinical development and early clinical testing. The emphasis is on building credible therapeutic candidates that could prevent Alzheimer’s disease, slow disease progression, or treat cognitive and behavioral symptoms, rather than generating new basic science insights.
This FOA specifically targets development of new small-molecule drugs and biologic therapeutics. It is designed to fund the kinds of activities that typically sit between an early discovery concept and a first-in-human study, where projects often stall due to cost and the need for specialized capabilities. Supported activities include medicinal chemistry and lead refinement, pharmacokinetics (PK) work, and comprehensive ADMET profiling (absorption, distribution, metabolism, excretion, and toxicology). It also supports efficacy testing in relevant animal models, formulation development to create a viable dosage form, and chemical synthesis under Good Manufacturing Practices (GMP) so that material used for clinical studies meets regulatory standards. In addition, the FOA supports IND-enabling studies (the package of safety and manufacturing data needed for an Investigational New Drug application) and can extend through initial Phase I clinical testing, making clinical trials optional rather than required.
At the same time, the program draws clear boundaries around what it will not fund. It is not intended for basic research on disease mechanisms or for studying mechanisms of drug action in a discovery sense. It does not support biomarker development, device development, or non-pharmacological interventions such as exercise programs, dietary approaches, or cognitive training. It also excludes projects based on repurposed drugs, combination therapies, or earlier discovery-stage activities like high-throughput screening and hit optimization. In practice, this means applicants are expected to come in with a defined therapeutic candidate or a sufficiently advanced lead series and a development plan that is oriented toward regulatory readiness and, potentially, a Phase I clinical entry.
The applicant pool is broad and includes many organization types. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The FOA also explicitly highlights eligibility for a range of institutions and organizations such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-U.S. (foreign) entities, and U.S. territories or possessions. The sponsoring agency is the National Institutes of Health.
In terms of funding details provided in the source information, the award ceiling is listed as $1,000,000. The FOA record shows a creation date of 2018-06-07 and an original closing date of 2021-11-15. Overall, the opportunity is best understood as a translational, milestone-driven pathway to advance Alzheimer’s therapeutics through the expensive and technically demanding preclinical-to-Phase-I transition, with NIH involvement typical of a cooperative agreement structure and a strong preference for projects that are clearly aligned with IND preparation and early human testing.Apply for PAR 18 820
- 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 2018-06-07.
- Applicants must submit their applications by 2021-11-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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Frequently Asked Questions (FAQs): Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional)
What is this funding opportunity?
This opportunity is the Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional), an NIH funding opportunity listed as PAR-18-820 (CFDA 93.866). It uses a cooperative agreement mechanism (U01) to support advanced, product-focused development of Alzheimer’s disease therapeutics.
Which agency sponsors this program?
The sponsoring agency is the National Institutes of Health (NIH).
What is the main goal of the program?
The goal is to move promising, novel Alzheimer’s disease therapeutics through practical, development-stage steps needed to reach the clinic. The program is geared toward late preclinical development and early clinical testing, with an emphasis on building credible therapeutic candidates that could prevent Alzheimer’s disease, slow disease progression, or treat cognitive and behavioral symptoms.
Is this program intended to generate new basic science discoveries?
No. The program is not intended to generate new basic science insights or support basic research on disease mechanisms in a discovery sense. It is focused on translational development work aimed at clinical readiness.
What types of therapeutics are targeted?
The FOA specifically targets development of new small-molecule drugs and biologic therapeutics for Alzheimer’s disease.
What stage of development is this FOA designed to support?
It is designed to support activities that typically fall between an early discovery concept and a first-in-human study. Applicants are generally expected to have a defined therapeutic candidate or a sufficiently advanced lead series and a plan oriented toward regulatory readiness (including IND preparation) and potentially entry into Phase I.
What kinds of activities can be supported under this FOA?
Supported activities include medicinal chemistry and lead refinement, pharmacokinetics (PK) work, comprehensive ADMET profiling (absorption, distribution, metabolism, excretion, and toxicology), efficacy testing in relevant animal models, formulation development for a viable dosage form, and chemical synthesis under Good Manufacturing Practices (GMP) to produce clinical-grade material.
Does the program support IND-enabling work?
Yes. The FOA supports IND-enabling studies, meaning the package of safety and manufacturing data needed to prepare for an Investigational New Drug (IND) application.
Are clinical trials required?
No. Clinical trials are optional rather than required. The FOA can extend through initial Phase I clinical testing, but applicants are not required to include a clinical trial.
What is meant by "cooperative agreement (U01)" in this context?
The FOA uses a cooperative agreement mechanism (U01), which typically involves NIH involvement consistent with the cooperative agreement structure. The program is described as milestone-driven and aligned with the preclinical-to-Phase-I transition.
What kinds of projects are explicitly not supported?
The FOA draws clear boundaries on what it will not fund. It is not intended for basic research on disease mechanisms or studying mechanisms of drug action in a discovery sense. It also does not support biomarker development, device development, or non-pharmacological interventions such as exercise programs, dietary approaches, or cognitive training.
Does the program fund drug repurposing projects?
No. Projects based on repurposed drugs are excluded under this FOA.
Does the program fund combination therapies?
No. Combination therapies are excluded under this FOA.
Does the program support early discovery activities like high-throughput screening?
No. Earlier discovery-stage activities such as high-throughput screening and hit optimization are excluded under this FOA.
Is biomarker development supported as part of this program?
No. Biomarker development is specifically listed as not supported.
Are devices or non-drug interventions eligible under this FOA?
No. Device development and non-pharmacological interventions (including exercise programs, dietary approaches, and cognitive training) are excluded.
Who is eligible to apply?
The applicant pool is broad. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities.
Are non-U.S. (foreign) entities eligible?
Yes. The FOA explicitly highlights eligibility for non-U.S. (foreign) entities.
Are U.S. territories or possessions eligible?
Yes. The FOA explicitly highlights eligibility for U.S. territories or possessions.
Are specific types of institutions explicitly highlighted as eligible?
Yes. The FOA explicitly highlights eligibility for institutions and organizations including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, and regional organizations.
What is the award ceiling listed for this opportunity?
The award ceiling is listed as $1,000,000.
When was the FOA record created and what was the original closing date?
The FOA record shows a creation date of 2018-06-07 and an original closing date of 2021-11-15.
What is the overall best-fit use case for this program?
This program is best suited for translational, milestone-driven projects that need support for the expensive and technically demanding transition from late preclinical development toward IND readiness and potentially early Phase I clinical entry, with an emphasis on product-focused development rather than discovery research.
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