Description

This opportunity supports the formation of multidisciplinary research groups to accelerate the discovery, preclinical development, and early-stage human testing of novel drugs and devices for the treatment of mental disorders, substance use disorders (SUDs), and alcohol use disorder (AUD). The program encourages innovative, high-impact research on new pharmacological agents, neurostimulation devices, and research tools (e.g., ligands, circuit-engagement devices) that address unmet needs in mental health. Partnerships between academia and industry are strongly encouraged to leverage complementary expertise and resources.

The program is designed for collaborative, multi-project research efforts that require a broad, multidisciplinary, and often long-term approach. Projects focused on a single, discrete research question should consider the companion U01 mechanism.

Research scope includes, but is not limited to:

• Discovery and validation of novel drug or device targets for mental disorders.
• Preclinical and early-stage clinical studies (up to first-in-human for devices, Phase Ia/Ib for drugs).
• Development of pharmacologic, neuromodulatory, or biomarker tools for experimental therapeutics.
• Preclinical discovery of biotechnology products and biologics (e.g., proteins, antibodies, gene/cell therapies, microbiome therapies).
• Application of machine learning and computational approaches to drug/device discovery.

Applications proposing analogs of established agents or lacking required attachments for clinical trials will not be considered.