The National Institutes of Health (NIH), through the National Institute of Mental Health (NIMH), has reissued the funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)," under the funding opportunity number PAR-25-352. This initiative is a cooperative agreement that facilitates partnerships between academic institutions and the pharmaceutical, biotechnology, and medical device industries to expedite the discovery and early development of novel therapeutics and neuromodulation devices for mental health disorders. The program fosters translational research from basic scientific discoveries to early human trials and encourages multidisciplinary collaboration to address significant unmet needs in psychiatric treatment.

The primary aim of this NOFO is to support the development and validation of new pharmacologic and neuromodulatory tools for both research and clinical applications. Eligible projects include the development of pharmacologic agents, neurostimulation devices, biotechnology products, biologics such as proteins and gene-based therapies, and emerging interventions like microbial or microbiome therapies. The initiative will fund studies from early preclinical discovery through to First-in-Human (FIH) and early-phase clinical trials. These trials must assess safety, tolerability, pharmacodynamics, and target engagement, and be designed to provide data necessary for further Proof of Concept (PoC) and efficacy trials.

The funding opportunity offers awards under the U01 cooperative agreement mechanism. Applications must focus on discrete, well-defined research projects and not broad, multi-project programs, which should instead be submitted under the companion U19 opportunity (PAR-25-353). Awards are not capped but must be justified by project needs, and the total project period may not exceed five years. Applicants must submit their applications electronically and follow all application instructions as outlined in the NIH Application Guide. Applications proposing clinical trials must include several mandatory attachments, such as milestone plans, clinical and data monitoring plans, and data management and sharing plans aligned with NIMH policies.

Eligible applicants include a wide range of organizations such as higher education institutions, non-profits, for-profits, and government entities, including local, state, and tribal governments. Foreign organizations may not apply, though foreign components of U.S.-based institutions are allowed. The principal investigator is required to devote a minimum of 1.8 person-months to the program, and all key personnel must be registered in NIH’s eRA Commons system. Partnerships that include in-kind contributions from industry collaborators are encouraged.

Applications are due multiple times per year: February 25, June 25, and October 25 through 2027. Letters of intent are encouraged 30 days prior to each due date. The earliest start dates for awards correspond with the NIH review cycles: December 2025, April 2026, July 2026, and so on. The NOFO is set to expire on October 26, 2027. The application process involves detailed review criteria, including the importance, rigor, feasibility, and innovation of the research, as well as the qualifications of the investigators and adequacy of institutional resources.

Applicants are urged to contact NIH staff to ensure that their proposals align with program priorities. For scientific questions, contact Yael Mandelblat-Cerf at yael.mandelblat-cerf@nih.gov. For peer review, contact Nicholas Gaiano at nick.gaiano@nih.gov. For financial management questions, contact Heather Weiss at weissh@mail.nih.gov. Applications must be submitted through Grants.gov or NIH ASSIST and comply with all NIH policies, including human subjects protection, data sharing requirements, and clinical trial registration and monitoring protocols.