Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (Phased Innovation Award R21/R33) | Apply Online

Opportunity Summary:

The NIH Funding Opportunity Announcement PA-06-463 focuses on building better brain imaging tools for central nervous system (CNS) research and drug development by supporting the development and early testing of new PET and SPECT radioligands. In plain terms, the opportunity is meant to help researchers create novel radioactive tracers that bind to specific biological targets in the human brain (such as receptors, transporters, enzymes, protein aggregates, or other molecular features) so those targets can be visualized and measured noninvasively with positron emission tomography (PET) or single photon emission computed tomography (SPECT). The bigger goal is to turn these imaging ligands into practical biomarkers that can be used both to understand disease biology (pathophysiology) and to speed up and de-risk drug discovery by showing whether a drug engages its intended target, how strongly it binds, where it goes in the brain, and how it changes the underlying biology over time.

The announcement is organized around a Phased Innovation Award mechanism, meaning it is explicitly designed to support a staged workflow that starts with high-impact early development and then moves into a more advanced feasibility phase if the project meets pre-specified milestones. The first phase uses the R21 mechanism, which typically supports exploratory or proof-of-concept work, such as designing and synthesizing candidate ligands, optimizing radiochemistry, and establishing preliminary evidence that a tracer has the right properties to be worth taking further. The second phase uses the R33 mechanism, which supports the next step: more extensive validation and feasibility testing that moves the ligand closer to real-world use as an imaging biomarker. What makes this FOA distinctive is that it expects applicants not only to invent new ligands but also to include pilot or clinical feasibility evaluation, which could be carried out through preclinical studies, model development, or clinical studies. In other words, the program is not limited to chemistry alone; it encourages a translational arc that connects ligand development to actual imaging performance and interpretability.

The scientific emphasis is on PET and SPECT imaging in the human brain, reflecting NIH interest in tools that can be applied directly to human CNS disorders. Projects responsive to this opportunity would generally aim to show that a candidate ligand has adequate specificity and selectivity for its target, suitable pharmacokinetics (brain entry and washout consistent with quantification), stability and an acceptable radiometabolite profile, and enough signal-to-noise to support reliable measurements. Because the FOA highlights biomarkers for drug discovery, successful applications would usually also make a clear case for how the ligand will be used in therapeutic development pipelines, for example by enabling target engagement studies, occupancy measurements, dose selection, patient stratification, or monitoring treatment response. At the same time, the FOA explicitly values pathophysiological studies, meaning ligands that help map disease processes in vivo across conditions like mental health disorders, neurodegenerative diseases associated with aging, alcohol use disorders, and substance use disorders are within the intended scope, aligning with the participating NIH Institutes.

Several NIH Institutes co-sponsor the FOA, including the National Institute of Mental Health (NIMH), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on Drug Abuse (NIDA). That mix signals that the program is meant to serve multiple neuroscience-related disease and public health areas, not a single diagnostic category. The listing of CFDA numbers further reinforces the breadth of relevance, spanning mental health research, alcohol research, drug abuse and addiction research, neuroscience and neurological disorders, aging research, and technological innovation to improve human health. In practice, applicants would be expected to position their imaging target and proposed ligand in a way that clearly connects to one or more of these mission areas, such as developing tracers for neurotransmitter systems, neuroinflammation pathways, protein aggregation, synaptic markers, or other molecular mechanisms implicated in CNS disease and treatment.

From an administrative standpoint, PA-06-463 is a discretionary grant opportunity using the NIH grant funding instrument. Cost sharing or matching is not required. The opportunity was posted August 7, 2006, and it used multiple receipt dates (rather than a single deadline), with a listed current closing date of September 7, 2009, and an archive date of October 7, 2009, indicating it is no longer active but remains available as a record of the program. The FOA’s “multiple receipt dates” structure meant that applications could be submitted at several standard NIH deadlines during the active period, with applicants directed to the full announcement for the exact schedule.

Eligibility is broad and includes many common NIH applicant categories: public and private institutions of higher education, nonprofits (including those with 501(c)(3) status and certain others), for-profit organizations (including but not limited to small businesses), state and local governments, county and township governments, special district governments, independent school districts, public housing authorities/Indian housing authorities, and Native American tribal governments and tribal organizations. The FOA also states that foreign institutions are eligible to apply, eligible federal agencies can apply, and faith-based or community-based organizations may apply. It also allows applicant organizations to submit more than one application as long as each application is scientifically distinct, which can matter for institutions with multiple tracer programs or separate targets under development.

Overall, the opportunity is best understood as an NIH push to strengthen the imaging biomarker pipeline for the brain by funding projects that connect radioligand invention to early validation and feasibility, with a clear line of sight to human application. The phased R21/R33 structure is intended to support innovation while still demanding practical progress, so applicants are expected to propose measurable milestones that justify moving from the exploratory phase into a more advanced development and evaluation phase. For anyone trying to build a PET or SPECT tracer program aimed at CNS targets, the FOA’s core message is that NIH is interested in ligands that are not just chemically novel, but demonstrably useful as quantitative, translatable biomarkers for understanding disease mechanisms and improving the efficiency and certainty of CNS drug development.

The full announcement and any detailed requirements, including milestone expectations and submission instructions, were provided through the NIH Grants Guide link: http://grants.nih.gov/grants/guide/pa-files/PA-06-463.html. For access or linking problems, the FOA lists the NIH Office of Extramural Research (OER) webmaster contact at FBOWebmaster@OD.NIH.GOV.

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Next opportunity: Dissemination and Implementation Research in Health (R03)

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

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