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National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)

US · MD National Institutes of Health (NIH) grant open #PAR-25-352
Response due Oct 25, 2027 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications under PAR-25-352 for the National Cooperative Drug/Device Discovery/Development Groups (NCDDG) program focused on the treatment of mental disorders. This is a U01 cooperative agreement mechanism with clinical trials optional. The program supports collaborative, multi-disciplinary research groups engaged in the discovery and development of novel drugs or devices targeting mental health conditions. The opportunity opened in January 2025 and accepts applications through October 2027, suggesting a multi-cycle funding announcement.

What they want

Applicants must form cooperative research groups to conduct drug and/or device discovery, development, and translational research aimed at identifying and advancing novel therapeutic candidates for the treatment of mental disorders. Work may optionally include clinical trials. The U01 mechanism implies a cooperative agreement structure where NIH staff have substantial programmatic involvement alongside the awardee.
Technical requirements
  • Cooperative, multi-disciplinary research group structure required
  • Research must focus on drug and/or device discovery or development for mental disorders
  • Clinical trial component is optional
  • Must comply with U01 cooperative agreement terms including NIH programmatic involvement

How they evaluate

  • Scientific and technical merit (NIH peer review process)
  • Innovation and significance
  • Approach and methodology
  • Investigator qualifications and team composition
  • Environment and resources
Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

  • Extremely long open window (Jan 2025 – Oct 2027) is standard for NIH Program Announcement with Receipt Dates (PAR) but may limit competitive urgency
  • Minimal detail provided in source text — full program requirements, budget limits, and eligibility criteria not available for review; full FOA (PAR-25-352) should be consulted on NIH Guide

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

National Cooperative Drug/Device Discovery…
Due Oct 25
Onboard ↗