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
Funding Amounts: No budget cap; budgets must reflect actual project needs. Maximum project period: 5 years. NIH intends to commit $27M in FY 2026 across this and companion NOFOs.
Summary: Supports confirmatory efficacy clinical trials of non-pharmacological and selected pharmacological interventions for mental disorders in adults and children, emphasizing experimental therapeutics and unmet therapeutic needs.
Key Information: Clinical trial required; strong preliminary evidence of target engagement and efficacy signal needed; limited to confirmatory efficacy stage (not initial development or effectiveness trials).