This National Institutes of Health (NIH) grant supports small business concerns (SBCs) developing therapeutic agents for alcohol use disorder (AUD) and/or alcohol-associated organ damage (AAOD). This grant is for advancing promising drug candidates from late discovery stages, like lead optimization and early safety studies, through to early-stage clinical trials. Applicants must present a therapeutic candidate with robust foundational data, demonstrating sufficient bioactivity, stability, and in vivo efficacy to transition into preclinical and clinical development. The primary objective is to accelerate the progression of these molecules toward U.S. Food and Drug Administration (FDA) approval. While early-phase clinical trials are optional, the core purpose is drug development. Women-owned and Small Disadvantaged businesses are encouraged to apply.
Opportunity ID: 337461
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-102 |
| Funding Opportunity Title: | Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (U43/U44 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.273 — Alcohol Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 21, 2022 |
| Last Updated Date: | Jan 21, 2022 |
| Original Closing Date for Applications: | Dec 04, 2024 |
| Current Closing Date for Applications: | Dec 04, 2024 |
| Archive Date: | Jan 09, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) supports Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for the treatment of alcohol use disorder (AUD) and/or alcohol associated organ damage (AAOD). As a starting point, eligible applicants must identify a therapeutic candidate with a robust body of background data in the basic science and early discovery phases to be ready for transition to the preclinical and clinical phases of development. Data may include having sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application. Projects responsive to this announcement could be undertaken at any point along the drug development continuum, from late discovery (i.e., lead optimization/early safety) up to early-stage clinical trials. For small molecules, the earliest stage of eligibility for this Award is already having small-molecule compounds with proof of desired pharmacological activity. For biologics, the profiling of promising product candidates in animal models of AUD or AAOD will be allowed as the earliest entry point. The ultimate purpose and goal of this FOA is to advance molecules closer to U.S. Food and Drug Administration (FDA) approval. Milestones will be commensurate with the project proposed and the purpose of this FOA. This FOA supports early-phase clinical trials, although these are not required. Women-owned and Small Disadvantaged small business are encouraged to apply. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-102.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 337461 Full Announcement-PAR-22-102 -> PAR-22-102-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00271451 | Feb 28, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00278445 | Nov 15, 2022 | Jan 24, 2025 | View |
Package 1
Mandatory forms
337461 RR_SF424_5_0-5.0.pdf
337461 PHS398_CoverPageSupplement_5_0-5.0.pdf
337461 RR_OtherProjectInfo_1_4-1.4.pdf
337461 PerformanceSite_4_0-4.0.pdf
337461 RR_KeyPersonExpanded_4_0-4.0.pdf
337461 RR_Budget_3_0-3.0.pdf
337461 PHS398_ResearchPlan_4_0-4.0.pdf
337461 SBIR_STTR_Information_3_0-3.0.pdf
337461 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
337461 RR_SubawardBudget30_3_0-3.0.pdf
337461 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
337461 RR_SF424_5_0-5.0.pdf
337461 PHS398_CoverPageSupplement_5_0-5.0.pdf
337461 RR_OtherProjectInfo_1_4-1.4.pdf
337461 PerformanceSite_4_0-4.0.pdf
337461 RR_KeyPersonExpanded_4_0-4.0.pdf
337461 RR_Budget_3_0-3.0.pdf
337461 PHS398_ResearchPlan_5_0-5.0.pdf
337461 SBIR_STTR_Information_3_0-3.0.pdf
337461 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
337461 RR_SubawardBudget30_3_0-3.0.pdf
337461 PHS_AssignmentRequestForm_3_0-3.0.pdf
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