Atom | First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)

Funder: National Institutes of Health

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.

First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)

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