National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)
Can you apply?
This grant is for researchers and research institutions seeking to participate in collaborative drug or device discovery and development efforts focused on mental health disorders. Eligible applicants typically include NIH-eligible domestic and foreign organizations such as universities, research institutions, nonprofit organizations, and other entities with the ability to conduct clinical research. Applicants must have appropriate research infrastructure, access to patient populations when needed, and the capacity to collaborate within a cooperative group model. The program supports transdisciplinary teams working to identify, develop, or test novel therapeutics and medical devices for mental health treatment, with clinical trial components optional depending on project stage and design. Geographic scope is primarily U.S.-based institutions, though some international collaboration may be permitted. The program emphasizes coordinated, multi-site research that accelerates the path from discovery to clinical application.
This grant is for researchers and research institutions seeking to participate in collaborative drug or device discovery and development efforts focused on mental health disorders. Eligible applicants typically include NIH-eligible domestic and foreign organizations such as universities, research institutions, nonprofit organizations, and other entities with the ability to conduct clinical research. Applicants must have appropriate research infrastructure, access to patient populations when needed, and the capacity to collaborate within a cooperative group model. The program supports transdisciplinary teams working to identify, develop, or test novel therapeutics and medical devices for mental health treatment, with clinical trial components optional depending on project stage and design. Geographic scope is primarily U.S.-based institutions, though some international collaboration may be permitted. The program emphasizes coordinated, multi-site research that accelerates the path from discovery to clinical application.
Program description
Reissue of PAR-20-118. This Notice of Funding Opportunity (NOFO) encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders, substance use disorders (SUDs) or alcohol use disorder (AUD), and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged. This NOFO using the U01 mechanism supports a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies Projects seeking support for a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach should consider the companion U19 FOA.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers and research institutions seeking to participate in collaborative drug or device discovery and development efforts focused on mental health disorders. Eligible applicants typically include NIH-eligible domestic and foreign organizations such as universities, research institutions, nonprofit organizations, and other entities with the ability to conduct clinical research. Applicants must have appropriate research infrastructure, access to patient populations when needed, and the capacity to collaborate within a cooperative group model. The program supports transdisciplinary teams working to identify, develop, or test novel therapeutics and medical devices for mental health treatment, with clinical trial components optional depending on project stage and design. Geographic scope is primarily U.S.-based institutions, though some international collaboration may be permitted. The program emphasizes coordinated, multi-site research that accelerates the path from discovery to clinical application.
How to apply
Application links
Required documents
- SF-424 (R&R) form and budget forms (PHS 398 or equivalent)
- Research strategy (specific aims, significance, innovation, approach, timeline)
- Preliminary data and publications demonstrating feasibility
- Letters of institutional commitment and team member commitment
- Biographical sketches and detailed CVs for all key personnel
- Data management and sharing plan
- Collaborative governance/coordination plan (for multi-site teams)
- IRB/IND/IDE documentation (if applicable to your research stage)
- Risk mitigation and go/no-go decision plan
- Reference lists and supporting documentation
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who is eligible to apply?
NIH-eligible organizations including universities, research institutions, hospitals, nonprofit organizations, and other domestic and foreign entities with research capacity. Individual researchers may apply through their host institution. Prior NIH funding experience is beneficial but not required.
What is the typical deadline and timeline?
This grant has a fixed deadline of October 25, 2027, with applications opening January 15, 2025. Check NIH's grants portal (Grants.gov) for the most current deadline information and any supplemental notices.
What types of activities and projects are supported?
This program supports collaborative drug and device discovery and development for mental health treatment. Activities may include basic research, translational science, preclinical development, regulatory pathway planning, and clinical trials (where appropriate). Multi-site, team-based approaches are prioritized.
How competitive is this grant?
This is a highly competitive NIH program. Success typically requires strong preliminary data, experienced research teams, clear innovation, and realistic timelines. Emphasis on collaborative synergy and mental health relevance is critical.
What is the typical funding range and award duration?
NIH U01 awards typically range from $300,000 to $500,000+ in direct costs annually, with multi-year funding periods (commonly 3–5 years). Actual amounts vary based on project scope and complexity. Consult the RFP for specific guidance.
💡 Tips for applicants
- Build a strong, multidisciplinary team early: This cooperative model expects collaboration across disciplines (psychiatry, pharmacology, neuroscience, biostatistics, clinical research). Demonstrate clear roles and complementary expertise, and secure letters of commitment from all team members before submission.
- Lead with preliminary data and innovation: Show that your drug/device discovery approach is novel and has promising preliminary results. NIH reviewers want evidence that your work addresses unmet needs in mental health treatment and represents a meaningful advance over existing approaches.
- Address the mental health focus clearly: Explicitly connect your drug/device development work to specific mental health disorders (depression, anxiety, bipolar disorder, schizophrenia, etc.). Articulate how your approach will improve patient outcomes and why existing treatments are inadequate.
- Plan for collaboration and communication: Detail how your multi-site team will coordinate, share data, and maintain communication. Include a governance plan, data-sharing agreements, and clear milestones for coordinating across sites. This demonstrates commitment to the cooperative model.
- If including a clinical trial, justify it well: If your U01 includes an optional clinical trial component, ensure it's well-powered, feasible, and tied to clear go/no-go decision points. Otherwise, focus on discovery, development, and regulatory readiness to bring the drug/device closer to human testing.
⚠️ Common mistakes
Applications often fail because they lack preliminary data sufficient to support the proposed discovery or development timeline, or because the team composition does not reflect true multidisciplinary collaboration and instead reads as siloed contributions. Reviewers frequently reject applications that do not clearly articulate the unmet medical need in the specific mental health disorder being targeted or that propose incremental modifications to existing therapies rather than genuinely novel approaches. Additionally, applications may underestimate the regulatory and manufacturing complexities of bringing a new drug or device to clinical testing, leading to unrealistic timelines and budget projections that undermine reviewer confidence.
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