OpportunityTitle: Innovative Pilot Studies of Novel Mechanism of Action Compounds for Treating Psychiatric Disorders (U01)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:   Alaska Native and Native Hawaiian Serving Institutions; Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.    Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Description: The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement grant applications to support experimental medicine-based first in human (FIH) and proof of concept (POC) studies of new mechanism of action, IND-ready candidate medications to treat mental disorders. The objective of the FOA is to accelerate the development of innovative pharmacological treatments through support of early phase human clinical testing. FIH pharmacology studies should assess target engagement, pharmacological effects, safety, and tolerability of novel compounds in order to build a pipeline for initial POC or efficacy trials in patients. POC studies of novel compounds should use pharmacologically based dosing, with assessment of target engagement and evaluation of the impact of compounds on clinically relevant physiological systems as well as clinical indicators of effect. The overall objective is to facilitate rapid collection of data to &quot;de-risk&quot; novel mechanism of action or combination treatments and to attract private funding for further clinical and commercial development of candidate medications. Partnerships between academia and industry are strongly encouraged.
GrantorContactEmailDescription: If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV &lt;br/&gt;