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.
Browse similar grants
Funder: National Institutes of Health
Due Dates: February 17, 2027 (Application) | June 15, 2027 (Application) | October 15, 2027 (Final application)
Funding Amounts: Budgets are not capped; pharmacological projects generally 1–5 years, device trials up to 4 years; no cost sharing
Summary: NIMH supports milestone-driven early clinical trials of novel investigational drugs and neuromodulatory devices for psychiatric disorders with unmet medical needs.
Key Information: Trials must involve a CRO, CTSA, or equivalent with relevant regulatory-quality clinical trial expertise.
Description
The National Institute of Mental Health (NIMH) administers this U01 cooperative agreement for first-in-human, Phase Ib, Phase II/proof-of-concept, and early feasibility trials in adult and pediatric populations. It supports novel-mechanism investigational drugs, rescued or repurposed drugs, and invasive or noninvasive neuromodulatory devices on a regulatory development path. Stand-alone studies or combinations of early-stage studies are eligible.
The program uses experimental medicine approaches to establish central nervous system target engagement, safety, tolerability, and dose-dependent effects. Phase II/proof-of-concept studies also assess functional biological measures and clinical signals of efficacy. The goal is to reduce uncertainty around promising interventions and attract further public or private investment toward FDA-approved treatments. Partnerships between biomedical researchers and biotechnology, pharmaceutical, or device researchers are a key feature.
