Sponsor Deadline
Posted: 4/17/2024

Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed)

The goal of this Funding Opportunity Announcement (FOA) is to identify, in animals, in vivo neurophysiological and behavioral measures for use as assays in the early screening phase of treatment development. This FOA will support efforts to optimize and evaluate measures of neurophysiological and behavioral processes that may serve as pharmacokinetic/pharmacodynamic (PK/PD) markers of neural processes of clinical interest based on available knowledge of the neurobiology of mental illnesses. The screening assays developed from this FOA are expected to build upon systems neurobiology and clinical neuroscience to enhance the scientific value of preclinical animal data contributing to a therapeutic development pipeline in which treatment candidates and therapeutic targets can be evaluated for their ability to impact neurobiological mechanisms of potential clinical relevance to mental illnesses.

The objectives of this FOA will be accomplished by supporting basic neuroscience aimed at improving the efficiency and scientific value of the therapeutic development pipeline by advancing the discovery of in vivo physiological and behavioral measures reflecting circuit engagement as tools for early phase target validation and therapeutic screening for mental illness treatment development. The efforts supported by this initiative focus on measures in animals as a first step in generating translational assay measures that are adaptable across early therapeutic screens in animals to evaluation in humans. The FOA may be considered a prequel to build a suite of assays that are evaluated in future projects for coherence of assay performance between the preclinical species and healthy humans. In summary, this FOA will support efforts to improve the tool kit of assays available for early phase testing of novel therapeutic agents by incorporating measures proximal to neural systems that impact mental health.


  • R01 Due Dates: Feb. 5, Jun. 5, Oct. 5
  • AIDS Due Dates: Jan. 7, May 7, Sep. 7

PAR-23-091 Expiration Date September 08, 2025

Amount Description

Application budgets are not limited but need to reflect the actual needs of the proposed project. It is expected that budgets of $250,000 direct costs per year or less will be adequate for most projects proposing to optimize just one measure.

The scope of the proposed project should determine the project period. The maximum period is 5 years.