Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Sep 13, 2026
Can you apply?
This grant is for researchers developing new drugs to prevent, slow, or treat Alzheimer's disease. Eligible applicants include academic institutions and biotech companies. Researchers can conduct preclinical and Phase I clinical work in their own labs or partner with contract research organizations. The program supports both small-molecule and biologic drug candidates targeting multiple disease mechanisms.
Not the right fit? Find grants for your organization in 5 questions →
Key dates
- Aug 13, 2026 Applications open
- Jun 18, 2027 Application deadline in 277 days
- Apr 30, 2028 Award announced
- Apr 30, 2028 Project start
Program description
The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose pre-clinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that aim to prevent Alzheimer’s disease (AD), slow its progression, or treat its cognitive and behavioral symptoms.
Through the NOFO, NIA is continuing the Alzheimer’s Drug-Development Program (ADDP) with the aim of catalyzing drug development for AD. The ADDP is designed to provide funding support to academic and biotech researchers for preclinical drug development activities that can be conducted in their own laboratories or conducted in collaboration with contract research organizations that specialize in preclinical drug development activities. By supporting the most challenging and costly steps of drug development and seamlessly connecting preclinical drug development and first-in-human testing for drug candidates, the ADDP program seeks to:
- Continue to expand the number of investigational new drug candidates for a portfolio of emerging therapeutic targets;
- Continue to expand the therapeutic pipeline for AD with drug candidates targeting multiple underlying disease mechanisms that can be used as mono-therapy or as part of combination therapy; and
- Enable a precision medicine approach to AD drug development.
The NOFO will utilize the U01 activity code. Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R)
- Project Narrative
- Biographical Sketches
- Budget and Budget Narrative
- Support Letters (if applicable)
Program contact
- 👤 NIA Scientific Program Contact
- 📧 NIA-NOFO-Scientific@nih.gov
- 📞 Please contact via e-mail
Funding track record
Recent awards under CFDA 93.866 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$463,372,200
-
$199,819,363
-
$148,130,300
-
$113,990,692
-
$109,670,101
-
$102,150,671
-
$89,954,729
-
$85,658,817
-
$81,449,732
-
$80,730,785
Top States by Funding
- CA 11 awards $747.1M
- MI 2 awards $528.1M
- MO 8 awards $476.4M
- IN 4 awards $328.1M
- PA 6 awards $323.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.866). How funding has trended year over year.
| 2024 | $3,746,886,731 | |
| 2025 | $3,777,464,644 | |
| 2026 est. | $261,814,471 |
FAQ
Who can apply for this grant?
Academic institutions and biotech companies with researchers conducting Alzheimer's drug development. Researchers can work independently or collaborate with contract research organizations.
What types of research does this grant fund?
Preclinical drug development and Phase I clinical trials for novel drug candidates that prevent, slow, or treat Alzheimer's disease.
What is the deadline for applications?
The deadline is June 18, 2027. Check the official NIH website for the most current information and any updates to the timeline.
Can I include clinical trial activities in my application?
Yes, clinical trial activities are optional. You can propose preclinical work alone or combine it with Phase I clinical testing.
What kinds of drugs does this program support?
Both small-molecule and biologic drug candidates are eligible. Projects can target multiple disease mechanisms for mono-therapy or combination therapy approaches.
💡 Tips for applicants
- Build strong collaborations early. The notice encourages applicants to develop meaningful partnerships before the application deadline.
- Clearly articulate your drug candidate's mechanism of action and how it addresses a specific Alzheimer's pathway.
- Consider whether your project needs preclinical work, clinical testing, or both. The U01 allows flexibility in study design.
- Emphasize how your approach contributes to a precision medicine strategy for Alzheimer's treatment.
- Address the competitive landscape and explain what makes your drug candidate novel compared to existing approaches.
⚠️ Common mistakes
Vague mechanism of action or unclear drug target rationale. Insufficient detail on preclinical evidence supporting Phase I readiness. Failure to demonstrate collaboration potential or realistic development timeline for moving to clinical testing.
Similar grants
- OPEN Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional) — National Institutes of Health
- OPEN Expanding the Therapeutic Pipeline for Treating and Preventing Alzheimer’s Disease and Related Dementias: Preclinical Validation and Drug Discovery for Novel Candidate Targets (U01 Clinical Trial Not — National Institutes of Health
- OPEN Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer’s Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Require — National Institutes of Health
- OPEN Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional) — National Institutes of Health