Efficacy and Exploratory Clinical Trials (UG3/UH3 – Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for researchers and research institutions conducting Phase II clinical trials to evaluate the efficacy and safety of interventions for neurological and neuropsychiatric disorders within NINDS portfolio. Eligible applicants include domestic nonprofits, universities, medical centers, for-profit organizations, and state/local government agencies. The grant supports the transition from early-stage research to controlled efficacy testing through a two-phase mechanism: UG3 (planning/pilot phase, typically 1-2 years) followed by UH3 (efficacy trial phase, typically 2-3 years). Applicants must have preliminary data demonstrating scientific merit and feasibility. Clinical trial design expertise, IRB approval, and established research infrastructure are essential. The program requires direct clinical application to NINDS research priorities in neurology, neurorehabilitation, neuropsychiatry, or related fields.
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Key dates
- Aug 28, 2025 Applications open
- Feb 10, 2026 Application deadline
- Nov 1, 2026 Award announced
- Dec 1, 2026 Project start
Program description
The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research on exploratory and efficacy clinical trials that address questions within the mission and research interests of the NINDS and may evaluate drugs, biologics, and devices, as well as surgical, behavioral and rehabilitation therapies. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the UG3/UH3 activity code. Investigators with expertise and insights into the mission and research interests of the NINDS, found at the NINDS website (https://www.ninds.nih.gov/), are encouraged to begin to consider applying for this new NOFO.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project Narrative (Research Strategy) including Significance, Innovation, Approach, timeline, and preliminary data
- Detailed Budget and Budget Justification (separate for UG3 and UH3 phases)
- Biographical Sketch (NIH format) for all key personnel
- Letters of Support from clinical trial sites and recruitment partners
- Clinical Protocol (or detailed protocol outline for UG3)
- Statistical Analysis Plan and power calculations
- Curriculum Vitae or Biographical Sketch for Project Director and Co-investigators
- Institutional Commitment and resources documentation
- IRB approval documentation (or plan for obtaining approval)
- Data Management and Safety Plan
Program contact
- 👤 Jeremy Brown, MD
- 📧 Exploratory_Efficacy_Trials@ninds.nih.gov
- 📞 Please contact via e-mail.
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$56,144,651
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$40,959,789
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$35,655,349
-
$35,655,116
-
$35,335,145
-
$34,183,297
-
$32,294,153
-
$32,234,840
-
$31,739,294
-
$27,282,286
Top States by Funding
- MA 5 awards $123.9M
- OH 4 awards $112.5M
- CA 4 awards $101.3M
- FL 3 awards $100.3M
- MI 3 awards $85.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
What types of neurological conditions are eligible for this grant?
NINDS supports clinical trials across a broad range of neurological and neuropsychiatric disorders including stroke, Parkinson's disease, Alzheimer's disease, epilepsy, pain conditions, autism spectrum disorder, schizophrenia, depression, traumatic brain injury, and multiple sclerosis. Consult the NINDS Division/program website to confirm your specific research area aligns with current priorities.
Do I need to have completed a Phase I trial before applying?
Not necessarily. You need preliminary data and evidence of safety and biological plausibility, but this can come from preclinical studies, small open-label trials, or published literature. A full Phase I trial strengthens your application but is not always required.
What is the difference between UG3 and UH3 phases?
The UG3 phase (typically 1-2 years, ~$275K/year) supports trial planning, protocol development, and feasibility/pilot work. The UH3 phase (typically 2-3 years, more substantial funding) funds the full efficacy trial. You apply for both phases in a single application, though UH3 funding is contingent on successful UG3 completion and progress review.
How competitive is this funding opportunity?
NINDS clinical trial funding is highly competitive. Success rates typically range from 10-15%. Reviewers prioritize applications with strong preliminary data, feasible timelines, experienced trial teams, diverse participant recruitment plans, and clear statistical power calculations. Innovation and potential public health impact are also evaluated.
What is the typical funding range?
UG3 phase typically provides $200K-$350K in direct costs per year; UH3 phase typically provides $350K-$1M+ depending on trial complexity, sample size, and duration. Actual awards vary significantly based on study design and scope.
💡 Tips for applicants
- Invest heavily in preliminary data and proof-of-concept: Reviewers want to see convincing evidence that your intervention works in your target population before committing to a full efficacy trial. Include results from prior studies, animal models, or small human studies.
- Assemble an experienced multidisciplinary team: Include clinicians, biostatisticians, trial methodologists, and subject-matter experts. If you lack clinical trial experience, partner with a clinical research organization or experienced trial coordinator. This significantly strengthens competitiveness.
- Develop a realistic, phased timeline with clear go/no-go criteria: Use the UG3 phase strategically to resolve critical uncertainties (feasibility, recruitment, safety signals). Define measurable milestones and decision points that justify progression to UH3 funding.
- Demonstrate robust recruitment and retention plans: Federal reviewers scrutinize participant accrual projections closely. Show detailed outreach strategies, letters of support from clinical sites, and evidence that your target population is accessible. Address diversity and inclusion proactively.
- Align with NINDS strategic priorities and clearly operationalize your primary outcome: Review recent NINDS program announcements and director priorities. Use validated, clinically meaningful outcome measures. Show how your trial advances the field and addresses an unmet clinical need.
⚠️ Common mistakes
Applications often fail because they lack sufficient preliminary data or present unconvincing evidence of biological mechanism and safety. Reviewers are also critical of overly optimistic timelines, inadequate statistical power calculations, weak recruitment plans that underestimate site capacity constraints, and failure to address diversity in participant enrollment. Insufficient detail about the intervention protocol, inadequate budget justification, or misalignment with NINDS research priorities also lead to rejections.
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