Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01 Clinical Trial Not Allowed) | PAR 20 037

Opportunity Information: Apply for PAR 20 037

The National Institutes of Health (NIH) funding opportunity PAR 20-037 supports R01 research grants focused on developing and applying new PET or SPECT imaging radioligands as biomarkers to advance drug discovery and to study the biology of central nervous system (CNS) disorders. The main emphasis is on preclinical radioligand development and evaluation, specifically in rodent and nonhuman primate brain, with the goal of producing imaging tools that can measure relevant molecular targets or processes in the living brain. These tools are intended to help researchers understand disease mechanisms (pathophysiology) and to improve how potential therapies are tested by providing quantitative, target-specific readouts that can be used in translational research.

Applications are expected to cover the practical, methodical work required to bring a novel CNS PET or SPECT tracer from concept toward readiness for broader use. This includes designing or identifying promising ligands, radiolabeling and chemistry optimization, and demonstrating that the tracer shows useful properties for brain imaging such as adequate brain penetration, strong and selective binding to the intended target, and imaging signals that are quantifiable and reproducible. The FOA also highlights the importance of building appropriate preclinical models and incorporating pilot or feasibility-style evaluation within the preclinical program, so that the resulting ligand is not just chemically interesting but also realistically usable as a biomarker in neuroscience and drug development settings.

This announcement is explicitly labeled "Clinical Trial Not Allowed," meaning the supported work should not involve a clinical trial as NIH defines it. The FOA does allow for pilot or feasibility evaluation in the context of preclinical studies, but projects that propose clinical assessments of novel radioligands are directed to apply under a different FOA (referenced in the text as PAR XX-XXX). In other words, this opportunity is meant to fund the preclinical pipeline and supporting model development rather than human efficacy or clinical testing of a new radiotracer.

The opportunity is discretionary and uses the grant funding instrument under NIH's health research mission. It falls under CFDA numbers 93.242 and 93.273. While the listing does not specify an award ceiling or the expected number of awards in the provided source text, it is structured as an R01 mechanism, which generally supports substantial, multi-year research projects with a defined set of aims and deliverables.

Eligibility is broad and includes many types of domestic and international organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses) as well as small businesses; and other organizations. The FOA also explicitly notes additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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-domestic (non-U.S.) entities (foreign organizations), U.S. territories or possessions, and certain Indian/Native American tribal governments other than federally recognized tribes. The sponsoring agency is NIH.

Key dates in the source data show a creation date of January 7, 2020, and an original closing date of January 7, 2023. Overall, PAR 20-037 is aimed at accelerating the availability of high-quality CNS PET/SPECT tracers that can function as robust biomarkers for mechanistic studies and for decision-making in the drug discovery and development process, while keeping the work grounded in preclinical validation and translational readiness rather than clinical trial activities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01 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): 93.242, 93.273.
• This funding opportunity was created on 2020-01-07.
• Applicants must submit their applications by 2023-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 20 037

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