NIH PAR · NIMH · U01

PAR-25-180: First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)

Reviewed by Dr. Meng ZhaoLast reviewed October 16, 2026Data refreshed October 16, 2026Editorial standards

Open for applicationsNext due date: Feb 17, 2027Expires Oct 16, 2027

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs…

Full NOFO in the NIH Guide Apply on Grants.gov

NOFO number
PAR-25-180
Type
PAR
Activity code
U01
Primary institute
NIMH · National Institute of Mental Health
Clinical trials
Required
Posted
Nov 26, 2024
Opens
Jan 14, 2025
Expires
Oct 16, 2027

PAR-25-180 due dates

3 application due dates remain before the NOFO expires. Dates marked * are NIH standard due dates. Check the related notices below for changes NIH made after posting.

Application due dates and review cycles for PAR-25-180
Application Due Date(s)Renewal / Resubmission / Revision (as allowed)AIDS - New/Renewal/Resubmission/Revision, as allowedScientific Merit ReviewAdvisory Council ReviewEarliest Start Date
February 14, 2025February 14, 2025Not ApplicableJuly 2025October 2025December 2025
June 17, 2025June 17, 2025Not ApplicableNovember 2025January 2026April 2026
October 15, 2025October 15, 2025Not ApplicableMarch 2026May 2026July 2026
February 13, 2026February 13, 2026Not ApplicableJuly 2026October 2026December 2026
June 15, 2026June 15, 2026Not ApplicableNovember 2026January 2027April 2027
October 15, 2026October 15, 2026Not ApplicableMarch 2027May 2027July 2027
February 17, 2027February 17, 2027Not ApplicableJuly 2027October 2027December 2027
June 15, 2027June 15, 2027Not ApplicableNovember 2027January 2028April 2028
October 15, 2027October 15, 2027Not ApplicableMarch 2028May 2028July 2028

What its predecessor PAR-21-133 funded

PAR-25-180 reissues PAR-21-133. Until awards appear under the new number, its funding history is the best guide to who wins under this program: 2 projects and $5.1M in FY2022–FY2026.

Projects funded

2

Distinct projects, FY2022–FY2026

New awards

2

Type 1 (new project) award records

NIH funding

$5.1M

Award dollars under PAR-21-133, FY2022–FY2026

Funding by fiscal year

Award records, new awards, and funding by fiscal year under PAR-21-133
Fiscal yearAward recordsNew awardsFunding
FY202200$0
FY202311$795K
FY202421$1.8M
FY202520$1.7M
FY202610$823K

Institutions with the most funding

  1. Columbia University Health Sciences$2.8M · 1 project
  2. Johns Hopkins University$2.3M · 1 project

Funding institutes

  • NIMH$5.1M · 6

Activity codes funded

Most recent new awards

FY2026 closed on September 30, 2026, but NIH keeps posting that year's awards to RePORTER for several weeks. FY2026 figures reflect records available on October 16, 2026 and may rise slightly at the next refresh.

Participating institutes

2 NIH institutes and offices take applications under PAR-25-180. Contact the program officer at the institute that fits your research before applying.

  • NIMH · National Institute of Mental Health
  • none

Related notices

  1. Jul 17, 2025 · NOT-MH-25-150

    Notice of Change to PAR-25-180 First in Human and Early State Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders U01 Clinical Trial Required).

  2. Mar 31, 2025 · NOT-OD-24-084

    This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25,…

  3. Aug 31, 2022 · NOT-OD-22-198

    Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.

  4. Aug 5, 2022 · NOT-OD-22-189

    Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Notices of Special Interest (NOSIs)

NIH has attached 1 NOSI to PAR-25-180; none are active now. A NOSI flags a topic an institute wants to fund through this NOFO.

Award terms

Application types allowed
NewRenewalResubmissionRevision Applicants seeking a renewal should reach out to the scientific contact prior to submission. The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Award budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Project period
For pharmacological agents, the duration of the project must be appropriate for the proposed project with a target goal of one year for completion of FIH, up to two years for completion of Phase Ib studies and three years for a Phase II/PoC study up to five years for applications to complete both phases).  Applicants should contact NIMH…
Funds available and number of awards
NIMH intends to commit a total of 27,000,000 million in FY 2026 to fund this NOFO and the companion NOFOs listed in Part 1. Overview Information. Future year amounts will depend on annual appropriations.

Summarized from the NOFO text; the full NOFO governs eligibility, budget, and review.

Related NOFOs

Other open NOFOs for U01

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About this page

GotGrant gathers the NOFO, its participation and change notices, and its NOSIs from the NIH Guide for Grants and Contracts, and counts funded projects from NIH RePORTER by the opportunity number each award was made under. Data refreshed October 16, 2026; the NIH Guide is the authoritative source. See our data methodology.

Find who wins under this NOFO

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