Opportunity Information: Apply for PAR 23 195
The NIH funding opportunity PAR-23-195, titled "Simultaneous and Synergistic Multi-Target Validation for Alzheimers Disease-Related Dementias (R61/R33 Clinical Trial not allowed)," is aimed at pushing Alzheimers disease and Alzheimers disease-related dementias (AD/ADRD) drug discovery beyond the traditional one-target-at-a-time model. The central idea is that AD/ADRD biology is complex and involves interacting pathways, cell types, neural circuits, organ-level systems, and overlapping pathologies. Because of that complexity, the FOA is designed to support projects that deliberately evaluate multi-target strategies, either by developing a single drug or biologic that hits multiple relevant targets, or by advancing a combination approach that uses more than one therapy together. The emphasis is on synergy: not just adding effects from multiple targets, but demonstrating that working on them together produces a stronger or more meaningful disease-modifying impact than tackling each target independently, similar to how combination or multi-mechanism treatments have been transformative in infectious disease and cancer.
This is a phased, milestone-driven R61/R33 mechanism. The R61 is the early, exploratory stage where applicants are expected to test clear hypotheses about beneficial interactions among known targets and to dig into the mechanisms behind those interactions. In practice, this phase is meant to reduce uncertainty around whether the proposed targets truly interact in a way that is therapeutically actionable, and to generate the evidence needed to justify a more intensive validation effort. The follow-on R33 phase supports rigorous validation of the multi-target concept, with the intent of producing a well-supported package of results that can serve as a launch point for translational development. The FOA frames success as putting teams in a strong position to pursue the next step in translation, specifically calling out the NIH IGNITE program and similar translational funding mechanisms as logical next destinations once a multi-target strategy is convincingly validated.
A key boundary condition is that clinical trials are not allowed under this announcement. That means the work should remain preclinical or otherwise non-clinical in a way that does not meet NIH definitions of a clinical trial. The scientific scope is broad in terms of what "targets" can mean, extending beyond single proteins to include pathways, cell states, circuit-level dysfunction, system-level processes, and distinct but co-occurring pathologies that shape AD/ADRD. The FOA is essentially inviting applicants to propose rational combinations or multi-functional interventions, then systematically prove that the interactions are real, beneficial, and mechanistically understandable enough to merit future therapeutic development.
From an administrative standpoint, this is a discretionary grant program administered by the National Institutes of Health, within the health funding activity category, and associated with CFDA numbers 93.853 and 93.866. The listed award ceiling is $499,000. The opportunity was created on 2023-06-20, with an original closing date of 2023-09-15. While the notice references expected awards, the provided source text does not specify a number.
Eligibility is intentionally broad and includes many types of U.S.-based organizations: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, certain tribal governments other than federally recognized, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Foreign eligibility is more restrictive. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as the applicant organization. Non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which typically means the project can include certain international elements or collaborations if structured as a foreign component under NIH policy rather than as a foreign applicant institution.
Taken together, the FOA is best read as an NIH effort to create a stronger evidence base for multi-target disease modification in AD/ADRD by funding a structured progression from mechanistic interaction testing (R61) to thorough validation (R33). The intended endpoint is not a clinical trial, but a compelling, well-validated multi-target therapeutic rationale and supporting data set that can feed directly into later-stage translational programs and eventual therapeutic development.Apply for PAR 23 195
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Simultaneous and Synergistic Multi-Target Validation for Alzheimers Disease-Related Dementias (R61/R33 Clinical Trial not allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
- This funding opportunity was created on 2023-06-20.
- Applicants must submit their applications by 2023-09-15. (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 $499,000.00 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: NIH PAR-23-195 (R61/R33) Multi-Target Validation for Alzheimer's Disease-Related Dementias
What is PAR-23-195?
PAR-23-195 is an NIH funding opportunity titled "Simultaneous and Synergistic Multi-Target Validation for Alzheimers Disease-Related Dementias (R61/R33 Clinical Trial not allowed)." It supports research that moves AD/ADRD drug discovery beyond a single-target approach by testing and validating multi-target therapeutic strategies.
What is the main goal of this funding opportunity?
The goal is to generate strong evidence that intentionally engaging more than one AD/ADRD-relevant target at the same time can produce a synergistic, disease-modifying effect. The emphasis is on demonstrating that the combined approach is meaningfully stronger or more informative than addressing each target independently.
Why does this FOA emphasize multi-target strategies for AD/ADRD?
The FOA is based on the idea that AD/ADRD biology is complex, involving interacting pathways, multiple cell types, neural circuits, organ-level systems, and overlapping pathologies. Because those features can interact, the opportunity is designed to support strategies that test how targeting multiple components together may better address disease mechanisms than a one-target-at-a-time model.
What kinds of multi-target approaches are encouraged?
The FOA supports either (1) a single drug or biologic designed to engage multiple relevant targets or (2) a combination approach that uses more than one therapy together, as long as the work is focused on demonstrating synergy and understanding the mechanisms behind the combined effects.
What does "synergy" mean in the context of this FOA?
Synergy here means more than simply adding together the individual effects of two targets or therapies. Applicants are expected to show that working on targets together produces a stronger or more meaningful disease-modifying impact than targeting them one-by-one, and to generate mechanistic evidence explaining why the interaction is beneficial.
What funding mechanism does this FOA use?
This opportunity uses the NIH R61/R33 phased innovation mechanism. It is milestone-driven and structured to move from early interaction testing (R61) to more rigorous validation (R33) if milestones are met.
What is the purpose of the R61 phase?
The R61 phase is the early, exploratory stage. It is intended for testing clear hypotheses about beneficial interactions among known targets and for investigating the mechanisms behind those interactions. This phase is designed to reduce uncertainty about whether proposed targets interact in a therapeutically actionable way.
What is the purpose of the R33 phase?
The R33 phase supports rigorous validation of the multi-target concept. The intent is to produce a strong package of results that can serve as a launch point for translational development after the project, even though clinical trials are not allowed under this FOA.
What is the intended endpoint of a successful project under this FOA?
The intended endpoint is not a clinical trial. Success is framed as creating a compelling, well-validated multi-target therapeutic rationale supported by mechanistic and validation data that positions the team for the next translational step.
Are clinical trials allowed under PAR-23-195?
No. Clinical trials are not allowed under this announcement. Projects must remain non-clinical or otherwise outside NIH's definition of a clinical trial.
Does "clinical trial not allowed" mean all human research is prohibited?
The information provided states that clinical trials are not allowed and that the work should remain preclinical or otherwise non-clinical in a way that does not meet NIH definitions of a clinical trial. It does not provide additional detail beyond that boundary condition.
How broadly does the FOA define "targets"?
"Targets" are defined broadly and can include not only single proteins but also pathways, cell states, circuit-level dysfunction, system-level processes, and distinct but co-occurring pathologies that influence AD/ADRD.
Is the FOA limited to any single type of AD/ADRD pathology?
No specific limitation is described in the provided information. The FOA explicitly mentions overlapping pathologies and a broad view of targets, suggesting applicants can address multiple interacting disease-relevant features.
What types of studies fit this FOA best?
Studies that rationally select more than one AD/ADRD-relevant target, intervention, or pathology to engage, then systematically test whether the combined engagement produces a synergistic and mechanistically understandable benefit, and finally validate that concept rigorously (across the phased R61/R33 structure).
What does "milestone-driven" mean for this opportunity?
The project is structured around defined milestones that guide progression from the R61 phase to the R33 phase. The provided information describes the R61 as generating evidence needed to justify the more intensive validation effort of the R33.
What translational programs are mentioned as next steps after this FOA?
The FOA specifically calls out the NIH IGNITE program and similar translational funding mechanisms as logical next destinations after a multi-target strategy is convincingly validated.
Which agency administers this grant program?
This is a discretionary grant program administered by the National Institutes of Health (NIH), within the health funding activity category.
What are the associated CFDA numbers?
The opportunity is associated with CFDA numbers 93.853 and 93.866.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $499,000.
When was this opportunity created, and what was the original closing date?
The opportunity was created on 2023-06-20, and the original closing date was 2023-09-15.
Does the provided information specify how many awards NIH expects to make?
No. The notice references expected awards, but the provided source text does not specify a number.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations, including state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations other than small businesses; and small businesses.
Are there specific types of institutions that the FOA explicitly highlights as eligible?
Yes. The FOA explicitly highlights Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, certain tribal governments other than federally recognized, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Can a non-U.S. (foreign) organization apply as the applicant?
No. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are not eligible to apply as the applicant organization.
Are foreign components allowed at all?
Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This typically means the project may include certain international elements or collaborations if structured as an NIH-allowable foreign component rather than a foreign applicant institution.
Does this FOA support single-target projects if they are strong?
The FOA is explicitly aimed at pushing beyond the traditional one-target-at-a-time model and is designed to support projects that deliberately evaluate multi-target strategies with an emphasis on synergy. The provided information does not describe support for single-target-only projects under this announcement.
What is the overall rationale for the phased structure (R61 to R33)?
The R61 phase is meant to test interaction hypotheses and mechanisms to reduce uncertainty and establish whether the multi-target interaction is actionable. The R33 phase then supports more intensive, rigorous validation to produce a strong evidence package suitable for the next translational step.
Is this opportunity focused on treatment development or basic research?
Based on the provided information, it is focused on generating a therapeutically actionable evidence base for multi-target disease modification that can feed into later translational development programs, while staying short of clinical trials.
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