First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
This grant funds early stage trials of new drugs and neuromodulatory devices for psychiatric disorders, aiming to de-risk and attract further funding.
Funder: National Institutes of Health
Due Dates: June 17, 2025 | October 15, 2025 | February 13, 2026 | June 15, 2026 | October 15, 2026 | February 17, 2027 | June 15, 2027 | October 15, 2027 (Applications) | May 18, 2025 | September 15, 2025 | January 14, 2026 | May 16, 2026 | September 15, 2026 | January 18, 2027 | May 16, 2027 | September 15, 2027 (Letters of Intent, 30 days prior)
Funding Amounts: No budget cap; budgets must reflect actual project needs. Typical project periods: up to 1 year (FIH), 2 years (Phase Ib), 3 years (Phase II/PoC), 4 years (device studies), or up to 5 years for combined phases. NIH intends to commit $27M in FY 2026 across this and companion NOFOs.
Summary: Supports early stage clinical trials of novel investigational drugs or neuromodulatory devices for psychiatric disorders to de-risk interventions and attract further development funding.
Key Information: Milestone-driven, cooperative agreement (U01); strong industry/biotech collaboration required; only clinical trials (not preclinical/animal studies) are eligible.
Description
This opportunity from the National Institute of Mental Health (NIMH), part of the NIH, funds early stage clinical trials of novel mechanism of action investigational drugs or neuromodulatory device-based interventions for psychiatric disorders. The goal is to accelerate the development of innovative treatments for psychiatric conditions, especially in areas of unmet medical need, by supporting first-in-human (FIH), Phase Ib, Phase II/proof-of-concept (PoC), and early feasibility studies (EFS) in both pediatric and adult populations.
The program is designed to generate rigorous, milestone-driven data on target engagement, safety, tolerability, and early efficacy, thereby "de-risking" new interventions and making them more attractive for further private or public investment and eventual FDA approval. A key feature is the requirement for collaborative partnerships between academic/biomedical researchers and industry or biotechnology partners.
