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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)
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Service Source Final Application Due Date Funding Available Match Required
Health Care Federal
HHS
12-04-2024 N/A No Match
Required
  • Service
  • Source
  • Final Application Due Date
  • Funding Available
  • Match Required
Status
  • Past
  • Current
  • Forecasted
    • Opportunity Type Discretionary
    • CFDA

      93.273 -- Alcohol Research Programs

    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.

    Eligibility
    • IHE
    • Local Government
    • Non-Profit
    • Other
    • State Government
    • Tribal Government
    Additional Eligibility Information

    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.

    Key Date(s)
    • January 21, 2022: Last Updated Date
    • January 21, 2022: Posted Date
    • December 04, 2024: Current Closing Date for Applications
    • December 04, 2024: Application Due Date
    • January 09, 2025: Application Archive Date
    Contact Information

    NIH OER Webmaster

    OERWebmaster03@od.nih.gov

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