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    Country
    Opportunity Status
    Funding Instrument Type
    Category
    Clear

    Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (UT1/UT2 Clinical Trial Optional)

    PAR-22-103

    National Institutes of Health

    Opening date 21 Jan 2022, 12:00AM

    Closing date 4 Dec 2024, 12:00AM

    Funding Opportunity Number: PAR-22-103

    Opportunity Category: Discretionary

    CFDA Number(s): 93.273 -- Alcohol Research Programs

    Cost Sharing or Matching Requirement: No

    Posted Date: Jan 21, 2022 12:00:00 AM EST

    Closing Date: Dec 04, 2024 12:00:00 AM EST

    Award Ceiling: none

    Award Floor: none

    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.

    Agency Name: National Institutes of Health

    Description: This Funding Opportunity Announcement (FOA) supports Small Business Technology Transfer (STTR) 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.

    Grantor Contact Information: NIH OER Webmaster OERWebmaster03@od.nih.gov

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