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.
Funder: National Institutes of Health
Due Dates: June 25, 2025 (New/Renewal/Resubmission/Revision) | October 25, 2025 | February 25, 2026 | June 25, 2026 | October 25, 2026 | February 25, 2027 | June 25, 2027 | October 25, 2027
Funding Amounts: No budget limit; project period up to 5 years; budgets must reflect actual project needs.
Summary: Supports multidisciplinary research to discover, develop, and test new drugs, devices, and neurostimulation approaches for mental disorders, with strong encouragement for academia-industry partnerships.
Key Information: Clinical trial optional; companion U19 FOA available for multi-project programs; limited submission—see eligibility details.
Description
This opportunity from the National Institutes of Health (NIH), led by the National Institute of Mental Health (NIMH), aims to accelerate the translation of innovative drug and device therapies for mental disorders from discovery through early human studies. The program supports the development and validation of pharmacologic and neuromodulatory tools, as well as early-stage human studies to assess safety, tolerability, and pharmacodynamics of promising candidates. The initiative strongly encourages partnerships between academia and industry, leveraging multidisciplinary teams to address unmet needs in mental health, substance use disorders (SUDs), and alcohol use disorder (AUD).
The program supports a single, discrete research project per application under the U01 cooperative agreement mechanism. For multi-project, multidisciplinary programs, applicants should consider the companion U19 funding opportunity.
