PAR-25-352
National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)
Summary
PAR-25-352: National Cooperative Drug/Device Discovery/Development Groups for Mental Disorders
Research Focus
This funding opportunity accelerates translation of novel pharmacological agents and neuromodulation devices from discovery through early human studies for mental health disorders. NIMH seeks applications advancing rational drug discovery, preclinical development, and proof-of-concept testing of innovative candidates targeting molecular, circuit, and oscillatory mechanisms underlying mood and anxiety disorders, schizophrenia, eating disorders, obsessive-compulsive disorder, autism, fragile X syndrome, and other psychiatric illnesses. The program supports development of pharmacologic and neurostimulation research tools (including positron emission tomography [PET] and single photon emission computed tomography [SPECT] imaging agents), validation of neurophysiological and pharmacodynamic biomarkers, and early-stage human studies assessing safety, tolerability, target engagement, and pharmacokinetic/pharmacodynamic effects. Research may encompass ligand discovery, large biologic macromolecules (proteins, antibodies, peptides), gene-based therapies (oligonucleotide and viral vector approaches), cell therapies, and emerging modalities (microbial and microbiome therapies). Academic-industry partnerships are strongly encouraged, with emphasis on experimental medicine approaches and Research Domain Criteria (RDoC) alignment.
At a Glance
- Who can apply: Academic, biotechnology, biomedical device, and pharmaceutical industry investigators; multidisciplinary teams with appropriate expertise; foreign institutions and NIH Intramural scientists may participate in some aspects.
- Funding & project length: Not stated (see award mechanism details in full FOA).
- Award mechanism: U01 (Research Project – Cooperative Agreement); single research project per application; multi-project programs should use companion PAR-25-353 (U19).
- Key dates: Applications due February 25, June 25, October 25, 2025 and continuing through 2027; earliest start date December 2025 (varies by cycle); expiration October 26, 2027.
- Best fit for: Drug/device discovery and early translational research teams in psychiatry and neuroscience pursuing Phase Ia/Ib trials or first-in-human device studies with target engagement and biomarker validation.
Key Facts
Deadline
Mon, October 25, 2027
Posted
Wed, January 15, 2025
Award / Year (direct costs)
$500,000
Max Total
$2,500,000
Max Duration
5 years
Keywords
Research Areas
Gotchas (3)
U01 mechanism limited to single Research Project; applications with multiple Research Projects must use companion U19 mechanism (PAR-25-353)
95%
Source Text
“A U01 application can include no more than a single Research Project. Applications proposing two or more Research Projects along with Scientific and/or Administrative Core components should respond to the companion NOFO utilizing the U19 mechanism (PAR-25-353)”
Funding supports only up to First-in-Human (FIH) for devices or Phase Ia/Ib trials for drugs; later-stage trials (Phase II+) are out of scope
95%
Source Text
“This NOFO will support up through First-in-Human (FIH) for devices or Phase Ia or Ib trials for pharmacological agents. For these trials, studies are expected to assess the agent/device for 1) safety and tolerability, 2) target engagement, and 3) pharmacodynamic effects on relevant circuits or systems.”
Projects must demonstrate major impact on unmet medical need, not merely incremental; vague standard that could lead to desk rejection
85%
Source Text
“The agent/indication (if successful) should have a major, not merely incremental, impact on unmet medical need in psychiatric disorders.”