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)
ID: 337461Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/337461

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-22-102.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for Small Business Innovation Research (SBIR) applications aimed at the development of medications to treat Alcohol Use Disorder (AUD) and Alcohol-Associated Organ Damage (AAOD). Eligible applicants, primarily small businesses, must propose therapeutic candidates with established preclinical data, ready for transition to clinical development, with projects permissible at various stages of the drug development continuum. This initiative is critical for advancing new therapies towards FDA approval, with funding limits of up to $1 million per year for Phase I (U43) and $1.5 million for Phase II (U44) applications. Interested parties should note that the application deadline is December 4, 2024, and can reach out to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further inquiries.

    Point(s) of Contact
    OERWebmaster03@od.nih.gov
    Files
    Title
    Posted
    PAR-22-102-Full-Announcement.html
    PAR-22-102.html
    The Department of Health and Human Services, through the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is issuing a Funding Opportunity Announcement (FOA) for Small Business Innovation Research (SBIR) applications focused on the development of new medications to treat Alcohol Use Disorder (AUD) and Alcohol-Associated Organ Damage (AAOD). This FOA supports projects at various stages of drug development, emphasizing the need for candidates with established preclinical data. Both Phase I (U43) and Phase II (U44) applications are welcome, with funding limits up to $1 million per year for Phase I and $1.5 million for Phase II. The announcement invites women-owned and socially or economically disadvantaged businesses to apply. Key submission dates include application deadlines, review timelines, and mandatory registrations. The document outlines eligibility criteria, required application content, and evaluation criteria that emphasize scientific merit, significance of the research, and potential for commercialization. Projects may involve preclinical to early-stage clinical trials, requiring adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP) to ensure compliance with regulatory standards, ultimately aiming to advance new therapies towards FDA approval.
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