Atom | Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01 Clinical Trial Optional)

Funder: National Institutes of Health

Funding Amounts: No budget cap; budgets must reflect actual project needs. Project period up to 5 years.

Summary: Supports development and evaluation of novel PET and SPECT imaging ligands as biomarkers for CNS disorder research and drug discovery, including pilot or clinical feasibility studies.

Key Information: Applicants requesting ≥$500,000 direct costs in any year must contact NIH program staff at least 6 weeks before submission.

Description

This opportunity invites research grant applications for the development and evaluation of novel radioligands for positron emission tomography (PET) or single photon emission computed tomography (SPECT) imaging in the human brain. The focus is on molecular targets implicated in central nervous system (CNS) disorders, with the goal of advancing these ligands for use as biomarkers in clinical research, drug discovery, and studies of disease pathophysiology. Projects may include pilot or clinical feasibility studies using pre-clinical data.

The program encourages collaborations between academia and industry to accelerate the development and application of PET/SPECT radiotracers for mental health and neurodegenerative disorders. Both pre-clinical and clinical research are supported, and clinical trials are optional.

Due Dates

New Applications: June 5, 2025 | October 5, 2025 | February 5, 2026
Renewal/Resubmission/Revision: July 5, 2025 | November 5, 2025 | March 5, 2026
AIDS-related Applications: September 7, 2025 | January 7, 2026 | May 7, 2026
Expiration Date: May 8, 2026

All applications are due by 5:00 PM local time of the applicant organization. Early submission is encouraged to allow time for corrections.

Funding Amount

Budget: No specific budget limit; budgets must be well-justified and reflect the actual needs of the proposed project.
Project Period: Up to 5 years.
Number of Awards: Contingent on NIH appropriations and the number of meritorious applications.

Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

Eligibility

Eligible organizations include:

Public/State and Private Institutions of Higher Education
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, County, City, Township, and Special District Governments
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American tribal governments (federally recognized and other)
Faith-based and community-based organizations
Regional organizations
U.S. Territories and Possessions
Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations

Eligible Individuals: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s).

Application Process

Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
Required Registrations: Applicant organizations must have active registrations in SAM, Grants.gov, and eRA Commons. PDs/PIs must have an eRA Commons account.
Application Guide: Follow the NIH How to Apply - Application Guide.
Forms: Use the SF424 (R&R) application package.
Page Limits: Adhere to the NIH Table of Page Limits.
Data Management and Sharing Plan: Required for all applications.
Resource Sharing Plan: Plan to share protocols, procedures, ligands, analytical tools, and other materials developed.
Human Subjects/Clinical Trials: Complete the PHS Human Subjects and Clinical Trials Information form if applicable.

Additional Information

Scope: Projects should focus on the development of PET/SPECT ligands for molecular targets relevant to CNS disorders, including but not limited to receptors, cell adhesion molecules, intracellular messengers, and disease-related proteins.
Feasibility: Applications must include data or literature supporting the feasibility of developing a radiotracer for the target (e.g., density and affinity in human brain regions).
Collaborations: Partnerships between academic and industry scientists are strongly encouraged.
Clinical Trials: Optional; both clinical and non-clinical studies are supported.
Review Criteria: Significance, innovation, approach, investigator(s), and environment, with specific attention to the justification for tracer development and feasibility.

External Links

Contact Information

Contact Type	Name/Title	Institute/Center	Email	Phone
Scientific/Research Contact	Dr. Enrique Michelotti	NIMH	michelottiel@mail.nih.gov	301-443-5415
Scientific/Research Contact	Dr. Alessandra Rovescalli	NIA	rovescaa@nih.gov	301-555-1212
Grants Management Contact	Heather Weiss	NIMH	weissh@mail.nih.gov	301-443-4415
Grants Management Contact	Philip Smith	NIA	philip.smith2@nih.gov	301-555-1212
General Grants Info	NIH Grants Information	NIH	GrantsInfo@nih.gov	301-480-7075
Grants.gov Support	Grants.gov Help Desk	Grants.gov	support@grants.gov	800-518-4726

For technical assistance with electronic submission, contact the eRA Service Desk:
https://www.era.nih.gov/need-help (301-402-7469 or 866-504-9552)