Opportunity Information: Apply for PAR 18 174
The Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (PAR 18-174; CFDA 93.866) designed to move promising Alzheimer’s disease (AD) therapeutics through the expensive, high-effort stretch between late preclinical work and first-in-human testing. The central aim is practical drug development: supporting small-molecule drugs and biologic therapeutics intended to prevent AD, slow disease progression, or treat cognitive and behavioral symptoms. In other words, this program is meant for teams that already have a defined therapeutic candidate or a well-advanced lead and need resources and structured support to complete the experiments and manufacturing steps that make a Phase I trial and an Investigational New Drug (IND) application feasible.
The work this FOA is willing to fund is very development-focused and includes many of the standard components needed to “de-risk” a candidate before and during early clinical entry. Examples specifically called out include medicinal chemistry (for optimizing and characterizing a small-molecule candidate), pharmacokinetics (PK) and broader ADMET studies (Absorption, Distribution, Metabolism, Excretion, and Toxicology), efficacy testing in relevant animal models, formulation development, and scale-up activities such as chemical synthesis performed under Good Manufacturing Practices (GMP). It also supports IND-enabling studies (the package of toxicology, pharmacology, manufacturing, and other documentation typically required for IND submission) and can extend into initial Phase I clinical testing. Because it is a U01 cooperative agreement, applicants should generally expect substantial NIH involvement beyond standard grant oversight, with a more collaborative relationship and programmatic input compared to typical investigator-initiated mechanisms.
Just as important, the FOA draws clear boundaries around what it will not support. It is not intended for basic research aimed at understanding disease mechanisms, nor for biomarker development efforts, device development, or non-pharmacological interventions such as exercise, dietary programs, or cognitive training. It also excludes repurposed drugs, combination therapies, and earlier discovery-stage activities like high-throughput screening and hit optimization. Taken together, those exclusions signal that NIH is using this program to fund candidates that are already on a translational track toward clinical testing rather than generating new targets, new screening hits, or new diagnostic tools.
Eligibility is broad and includes many types of U.S.-based and some non-U.S. organizations. Eligible applicants listed for the opportunity include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (other than institutions of higher education); public housing authorities/Indian housing authorities; federally recognized Native American tribal governments as well as tribal organizations and tribal governments that are not federally recognized; for-profit organizations other than small businesses; small businesses; and other entities. The FOA also explicitly notes additional eligible applicants 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, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This breadth reflects an intent to pull in strong development teams wherever they are based, including academic groups, biotech and pharma developers, and mission-driven organizations with the capacity to run regulated development work.
From the funding details provided, the mechanism is discretionary and uses a cooperative agreement instrument, with an award ceiling listed at $1,000,000. The original closing date in the source data is June 7, 2018, and the record creation date is November 8, 2017. While those dates indicate the specific posting referenced is historical, the description captures the program’s core purpose: accelerating Alzheimer’s therapeutic candidates through preclinical development milestones, GMP manufacturing and IND readiness, and into early Phase I human testing when appropriate, while avoiding basic discovery or non-drug intervention work.Apply for PAR 18 174
- 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 2017-11-08.
- Applicants must submit their applications by 2018-06-07. (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)
What is the Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional)?
The Alzheimer’s Drug-Development Program is an NIH cooperative agreement funding opportunity (PAR 18-174; CFDA 93.866) focused on practical drug development for Alzheimer’s disease (AD). It is designed to help move promising therapeutic candidates through the costly and high-effort stage between late preclinical work and first-in-human testing.
What is the main goal of this funding opportunity?
The central goal is to advance Alzheimer’s therapeutics toward clinical entry by supporting the experiments and manufacturing steps needed to make a Phase I trial and an Investigational New Drug (IND) application feasible. The emphasis is on “de-risking” a defined candidate so it can credibly progress toward IND submission and early human testing.
What types of therapeutics are supported?
The program supports small-molecule drugs and biologic therapeutics intended to prevent Alzheimer’s disease, slow disease progression, or treat cognitive and behavioral symptoms.
Is this opportunity meant for early discovery research or for advanced candidates?
This opportunity is meant for teams with a defined therapeutic candidate or a well-advanced lead. It is positioned for projects that are already on a translational track toward clinical testing, not for generating new targets or early hits.
What kinds of activities and studies can be funded?
The FOA is development-focused and can support many standard steps needed to prepare a candidate for IND submission and early clinical entry. Examples specifically described include:
- Medicinal chemistry (optimizing and characterizing small-molecule candidates)
- Pharmacokinetics (PK) and ADMET studies (Absorption, Distribution, Metabolism, Excretion, and Toxicology)
- Efficacy testing in relevant animal models
- Formulation development
- Scale-up activities, including chemical synthesis under Good Manufacturing Practices (GMP)
- IND-enabling studies (toxicology, pharmacology, manufacturing, and documentation typically required for IND submission)
- Potential extension into initial Phase I clinical testing
Does the program support IND-enabling work?
Yes. The FOA explicitly supports IND-enabling studies, which generally include the toxicology, pharmacology, manufacturing, and other documentation needed to prepare an IND submission.
Does the program allow clinical trials?
Yes. The FOA is labeled “Clinical Trial Optional” and it may support work extending into initial Phase I clinical testing when appropriate, in addition to preclinical and IND-enabling activities.
What does it mean that this is a U01 cooperative agreement?
A U01 is a cooperative agreement mechanism, meaning NIH involvement is expected to be substantial compared to typical investigator-initiated grants. Applicants should anticipate a more collaborative relationship, with programmatic input beyond standard oversight.
What kinds of projects are specifically not supported?
The FOA draws clear boundaries and excludes several categories of work. It is not intended to support:
- Basic research aimed at understanding disease mechanisms
- Biomarker development efforts
- Device development
- Non-pharmacological interventions (for example: exercise, dietary programs, cognitive training)
- Repurposed drugs
- Combination therapies
- Earlier discovery-stage activities (for example: high-throughput screening and hit optimization)
Are repurposed drugs eligible under this program?
No. Repurposed drugs are explicitly listed among the exclusions for this FOA.
Are combination therapies eligible?
No. Combination therapies are explicitly excluded under this FOA.
Does this FOA fund high-throughput screening or hit optimization?
No. Earlier discovery-stage activities such as high-throughput screening and hit optimization are specifically excluded.
Does this FOA fund biomarker development or diagnostic tool development?
No. Biomarker development is excluded, and the FOA is not positioned as a diagnostic/tool-development program.
Does this FOA fund devices or non-drug interventions?
No. Device development and non-pharmacological interventions (such as exercise, dietary programs, or cognitive training) are excluded.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organization types and also non-U.S. (foreign) organizations. Eligible applicants listed include:
- State, county, city/township, and special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
- Public housing authorities/Indian housing authorities
- Federally recognized Native American tribal governments
- Tribal organizations and tribal governments that are not federally recognized
- For-profit organizations other than small businesses
- Small businesses
- Other entities
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The FOA explicitly includes non-domestic (non-U.S.) entities (foreign organizations) as eligible applicants.
Are special categories of institutions and community organizations included in eligibility?
Yes. The FOA explicitly notes additional eligible applicants 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, and U.S. territories or possessions.
What is the maximum award amount listed for this opportunity?
The funding details provided list an award ceiling of $1,000,000.
What is the CFDA number and NIH program reference?
The opportunity references CFDA 93.866 and the FOA identifier PAR 18-174.
What is the closing date shown for the referenced posting?
The original closing date in the provided source data is June 7, 2018.
Is this grant posting current or historical?
Based on the dates provided (record creation date of November 8, 2017 and closing date of June 7, 2018), the specific posting referenced is historical, even though the description summarizes the program’s core purpose.
What stage of development is this program trying to bridge?
It is designed to bridge the “expensive, high-effort” stretch between late preclinical development and first-in-human testing, including the steps needed for GMP readiness, IND preparation, and early Phase I entry when appropriate.
Why does the FOA emphasize “practical drug development”?
The FOA is structured to support the concrete, regulated development tasks required to make a credible transition to human testing (for example, ADMET, formulation, GMP scale-up, and IND-enabling packages), rather than exploratory biology or early-stage discovery.
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