DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award
Can you apply?
This grant is for researchers developing therapeutic compounds for amyotrophic lateral sclerosis (ALS). Applicants must have lead compounds with proven efficacy in at least one appropriate ALS preclinical model system. Research must range from preclinical validation through FDA Investigational New Drug (IND)-enabling studies.
Applicants with limited ALS experience should include collaborators experienced in relevant ALS model systems and disease pathophysiology. Compounds that have already received IND approval are not eligible for this award.
This is a U.S. federal grant supporting empirical, product-driven research that develops therapeutic candidates toward clinical translation. Eligible institutions typically include academic medical centers, biotech companies, and research organizations capable of conducting rigorous preclinical and translational studies.
Program description
Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited amyotrophic lateral sclerosis (ALS) experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints and pathophysiology.
Applications supported by this award must begin with lead compounds in hand and must already demonstrate proof-of-concept efficacy data in at least one appropriate preclinical model system of ALS, including whole-animal and cellular model systems.
Distinctive Features: Mechanism-specific, predictive/cohort-selective, target engagement and pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component of the FY26 ALSRP Therapeutic Development Award. If appropriate mechanism-specific biomarkers are already available or currently in development, how the existing biomarkers will improve trial design, patient selection, and efficiency or interpretation of the proposed ALS therapeutic approach must be apparent in the application. Development of biomarkers for the purposes of diagnosis, prognosis, or measurement of general disease progression without consideration of the therapeutic development process will not be supported.
Therapeutic candidates which have already been granted an IND are not appropriate for this mechanism.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Federal Grant Application Form)
- Project Narrative/Research Plan
- Budget and Budget Justification
- Biographical Sketches (Key Personnel)
- Letters of Support (collaborators, consultants)
- Preclinical Model System Documentation
- Proof-of-Concept Data Summary
- Biomarker Development Plan
Program contact
- 👤 Jamie Shortall Grant Officer
- 📧 help@eBRAP.org
- 📞 301-619-2393
Funding track record
Recent awards under CFDA 12.420 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$2,265,729,366
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$800,631,761
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$74,531,880
-
$67,205,571
-
$53,718,832
-
$34,191,124
-
$24,907,742
-
$21,394,379
-
$19,100,256
-
$19,002,641
Top States by Funding
- MD 10 awards $3,150.1M
- NC 11 awards $132.3M
- FL 8 awards $99.8M
- CA 11 awards $99.3M
- MA 7 awards $75.2M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 12.420). How funding has trended year over year.
| 2024 | $1,483,968,520 | |
| 2025 | $1,201,153,417 |
FAQ
Do I need proof-of-concept data before applying?
Yes. Applications must begin with lead compounds in hand and demonstrate efficacy in at least one appropriate ALS preclinical model system.
Can compounds with IND status apply?
No. Therapeutic candidates already granted an IND approval are not appropriate for this mechanism.
Is biomarker development required?
Yes. Mechanism-specific, predictive biomarker development in parallel to the main therapeutic effort is a critical component of this award.
What types of studies are supported?
Research from preclinical validation of therapeutic leads through FDA IND-enabling studies is supported.
Should I include ALS collaborators if I lack experience?
Yes. Applicants with limited ALS experience are strongly encouraged to include collaborators with substantial experience in relevant ALS model systems and pathophysiology.
💡 Tips for applicants
- Start with validated lead compounds and documented proof-of-concept efficacy in appropriate ALS preclinical models before applying.
- Develop mechanism-specific biomarkers in parallel to your therapeutic development; explain how they will improve trial design and patient selection.
- Partner with ALS domain experts if your team lacks substantial experience with ALS model systems and endpoints.
- Focus on empirical, product-driven research with clear path toward FDA IND-enabling studies.
- Clearly articulate how existing or planned biomarkers will enhance your therapeutic approach's efficiency and interpretation.
⚠️ Common mistakes
Applications lacking proof-of-concept efficacy data in appropriate ALS preclinical models are not competitive. Biomarker development plans that focus only on diagnosis or disease progression without therapeutic context will not be supported. Compounds already possessing IND approval are ineligible regardless of other merits.
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