Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) | PAR 18 174

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.

• 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.

Apply for PAR 18 174

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