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NIH Research Project Cooperative Agreement (U01)

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

Funds the first human trials of a novel-mechanism psychiatric drug or a novel neuromodulatory device, with milestones gating each step.

OpenNational Institutes of HealthUnited States

This is the notice a psychiatric drug or device company should read first. It funds the step into people, for both modalities, under one announcement.

What qualifies is novelty of mechanism. Investigational drugs with a novel mechanism of action, or novel neuromodulatory devices, for psychiatric disorders in areas of unmet medical need. Paediatric and adult populations are both in scope, and the …

Milestone-driven early-stage clinical trials of novel mechanism of action investigational drugs and novel neuromodulatory devices for psychiatric disorders in areas of unmet medical need, in paediatric and adult populations — first-in-human and phase II drug studies assessing target engagement, pharmacological effects, safety and tolerability; proof-of-concept studies evaluating functional and clinical measures; and first-in-human and early feasibility device studies. A clinical trial is required.

CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.Multiple per year
Next deadlineiThe next date applications are due. Rolling means you can apply any time.15 Oct 2027
Decision timeiTypical time from the deadline to the funder's decision.26 weeks
Project durationiHow long the funded work is expected to run.—
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Cooperative agreement
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.—
Funding pooliThe total budget available across all awards in this round.—

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Last verified: 25 Aug 2026Funder reference: PAR-25-180Source: www.grants.gov