National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)
Funding available for research on innovative drug and device treatments for mental disorders, substance use, and alcohol use, promoting collaboration between academia and industry through U01 mechanism.
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Funder: National Institutes of Health
Due Dates: February 25, 2027 (Applications) | June 25, 2027 (Applications) | October 25, 2027 (Applications)
Funding Amounts: No budget cap; requests must reflect project needs; up to five years; no cost sharing required
Summary: Supports discovery, preclinical development, and early human testing of novel drugs, neurostimulation devices, and research tools for mental and addictive disorders.
Key Information: Only one research project per application; each PD/PI is expected to commit at least 1.8 person-months.
Description
This NIH cooperative agreement, administered by the National Institute of Mental Health (NIMH), supports multidisciplinary drug and device discovery and development. Work may span novel ligands, target-validation tools, biologics, gene and cell therapies, imaging tracers, and neuromodulation technologies through early human studies. The program seeks rationally based treatments and tools that address unmet needs in mental disorders; the Grants.gov listing also includes substance use and alcohol use disorders.
Academic–industry partnerships and partners’ in-kind contributions are strongly encouraged. Projects should connect novel molecular, circuit, or clinical targets to disease biology and assess target engagement. Clinical support extends through first-in-human device studies or Phase Ia/Ib drug trials, emphasizing safety, tolerability, and pharmacodynamic effects. The U01 supports a single, circumscribed project; multi-project programs should consider the companion U19 opportunity.
