Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R21) | Apply Online

Opportunity Summary:

The grant opportunity PA 13-157 is an NIH R21 (Exploratory/Developmental) funding announcement focused on creating and early-testing new brain imaging radioligands for PET (positron emission tomography) or SPECT (single photon emission computed tomography). Its central purpose is to accelerate the development and application of imaging biomarkers that can be used both in drug discovery (for example, to confirm target engagement, measure receptor occupancy, or track pharmacodynamic effects in the living human brain) and in studies aimed at understanding the biology and progression of central nervous system (CNS) disorders. The FOA is specifically oriented toward novel radiotracers that can be translated to, or directly evaluated in, humans, and it expects applicants to pair ligand development with some form of feasibility assessment, such as pilot preclinical evaluation, initial modeling work, or early clinical studies.

In practical terms, the FOA supports work along the radioligand pipeline: identifying or designing candidate compounds, radiolabeling them with appropriate isotopes, and establishing whether they have the characteristics needed for a useful PET or SPECT brain imaging agent. That typically includes demonstrating adequate brain penetration, target specificity and selectivity, a favorable signal-to-noise profile, measurable and interpretable binding, and kinetics that can be modeled to yield quantitative or semi-quantitative outcomes. The announcement emphasizes that projects should not stop at chemistry alone; they should incorporate early evaluation steps that show the ligand has a plausible path to real-world use. Depending on the project, that might mean in vitro binding assays and autoradiography, animal imaging with kinetic analysis, metabolite and plasma input function characterization, dosimetry estimates for human use, or small pilot studies in people to assess safety, brain uptake, target binding, and test-retest reliability.

The broader scientific motivation is that PET and SPECT ligands can serve as biomarkers that de-risk neuroscience drug development and deepen knowledge of disease mechanisms. Imaging ligands can help determine whether a drug is reaching the brain, whether it binds its intended molecular target, how much occupancy is achieved at a given dose, and how target engagement relates to clinical or behavioral outcomes. They can also enable pathophysiological studies by mapping abnormalities in receptors, transporters, enzymes, protein aggregates, neuroinflammation markers, or other molecular processes implicated in psychiatric, neurodegenerative, substance use, and aging-related CNS conditions. The FOA aligns with multiple NIH research areas reflected in its CFDA listings, including mental health, alcohol research, drug abuse and addiction, and aging research, indicating that proposed ligands and applications may span a wide range of CNS disorders and research questions.

As an R21 mechanism, the opportunity is designed for exploratory, proof-of-concept, and early-stage development rather than large, definitive clinical validation studies. The posted award ceiling in the source data is $175,000, and the announcement states there is no cost sharing or matching requirement. The activity category is listed as Education/Health, and the sponsoring agency is the National Institutes of Health. While the source excerpt does not list project duration, R21 awards are generally intended for shorter, high-impact developmental efforts, and applicants typically use this mechanism to generate the critical preliminary data needed for subsequent, larger-scale grant applications.

Eligibility is broad and includes many types of organizations. Eligible applicants include small businesses and other for-profit organizations (other than small businesses), nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, and a wide range of government entities (state, county, city/township, special district, and certain tribal governments and organizations). The FOA also explicitly allows applications from non-U.S. entities and foreign institutions, as well as non-U.S. components of U.S. organizations, and it permits foreign components as defined in the NIH Grants Policy Statement. In addition, it highlights eligibility for various mission-driven and minority-serving institutions and community-based or faith-based organizations, including HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and U.S. territories or possessions.

Key dates in the provided record indicate the FOA was posted March 25, 2013, with an original closing date of January 7, 2016. The record also shows a current closing date of July 24, 2013 and an archive date of August 24, 2013, meaning the opportunity is no longer active in this form and was archived after that period. For full details, the announcement was available through the NIH Grants Guide at the provided link (http://grants.nih.gov/grants/guide/pa-files/PA-13-157.html). For access or technical issues, NIH directs applicants to contact the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

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Next opportunity: Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R21/R33)

Previous opportunity: Further the Education Goals of the University of Alaska, Department of Alaska Native and Rural Development and the National Park Service Through the Sponsorship of a Student Annual Spring Seminar and Recruitment Program

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