Opportunity ID: 358724

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942525ALSRPTDA
Funding Opportunity Title: DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 5
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Apr 18, 2025
Last Updated Date: May 23, 2025
Original Closing Date for Applications: Aug 27, 2025
Current Closing Date for Applications: Aug 27, 2025
Archive Date: Sep 26, 2025
Estimated Total Program Funding: $10,500,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through 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 FY25 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

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org

Version History

Version Modification Description Updated Date
Pages 4 and 9 of the Program Announcement (PA) have been updated to reflect a change in the funding details from a total direct cost cap to a total cost cap. The Estimated Total Program Funding amount has been updated in the PA and synopsis. Additionally, a weblink under section 6.4 has been updated in the PA (page 26). May 23, 2025
Grantor contact info updated Apr 18, 2025
Apr 18, 2025

DISPLAYING: Synopsis 3

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942525ALSRPTDA
Funding Opportunity Title: DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 5
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Apr 18, 2025
Last Updated Date: May 23, 2025
Original Closing Date for Applications: Aug 27, 2025
Current Closing Date for Applications: Aug 27, 2025
Archive Date: Sep 26, 2025
Estimated Total Program Funding: $10,500,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through 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 FY25 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

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942525ALSRPTDA
Funding Opportunity Title: DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 4
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Apr 18, 2025
Last Updated Date: Apr 18, 2025
Original Closing Date for Applications:
Current Closing Date for Applications: Aug 27, 2025
Archive Date: Sep 26, 2025
Estimated Total Program Funding: $9,800,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through 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 FY25 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

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org

DISPLAYING: Synopsis 1

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942525ALSRPTDA
Funding Opportunity Title: DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 4
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Apr 18, 2025
Last Updated Date: Apr 18, 2025
Original Closing Date for Applications:
Current Closing Date for Applications: Aug 27, 2025
Archive Date: Sep 26, 2025
Estimated Total Program Funding: $9,800,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through 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 FY25 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

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Jamie Shortall

Grant Officer

Phone 301-619-2393
Email:jamie.a.shortall.civ@health.mil

Folder 358724 Full Announcement-FY25 ALSRP TDA -> HT9425FY25ALSRPTDA_updated.pdf

Packages

Agency Contact Information: CDMRP Help Desk
Phone: 301-682-5507
Email: help@eBRAP.org
Email: help@eBRAP.org
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
12.420 PKG00290608 Apr 18, 2025 Aug 27, 2025 View

Package 1

Mandatory forms

358724 RR_SF424_5_0-5.0.pdf

358724 AttachmentForm_1_2-1.2.pdf

358724 RR_PersonalData_1_2-1.2.pdf

358724 RR_KeyPersonExpanded_4_0-4.0.pdf

358724 RR_Budget_3_0-3.0.pdf

358724 PerformanceSite_4_0-4.0.pdf

Optional forms

358724 RR_SubawardBudget30_3_0-3.0.pdf

2025-07-13T19:21:17-05:00

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