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)
ID: 337477Type: 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/337477

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-22-103.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for the Investigational New Drug (IND)-enabling and early-stage development of medications aimed at treating Alcohol Use Disorder (AUD) and alcohol-associated organ damage (AAOD). This initiative, designated as funding opportunity PAR-22-103, invites Small Business Technology Transfer (STTR) applications from small businesses that demonstrate readiness for preclinical and clinical development of therapeutic agents with a solid foundation in basic science and early development phases. The program emphasizes the urgent need for new therapies to combat AUD and associated organ damage, with funding amounts reaching up to $1 million for Phase I and $1.5 million for Phase II, and project durations of up to two and three years, respectively. Interested applicants can find more information and contact details at the NIH website, with the application deadline set for December 4, 2024.

    Point(s) of Contact
    OERWebmaster03@od.nih.gov
    Files
    Title
    Posted
    PAR-22-103-Full-Announcement.html
    PAR-22-103.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), announces a funding opportunity for the Investigational New Drug (IND)-enabling and early-stage development of medications to treat Alcohol Use Disorder (AUD) and alcohol-associated organ damage (AAOD). This initiative, designated as funding opportunity PAR-22-103, supports Small Business Technology Transfer (STTR) applications aimed at advancing therapeutic agents with a strong foundation in basic science and early development phases. Eligible projects must demonstrate readiness for preclinical and clinical development, focusing on small molecules or biologics with proven bioactivity. The initiative encourages applications from women-owned and socially or economically disadvantaged small businesses. Budgets can reach $1 million for Phase I and $1.5 million for Phase II, with project durations of up to two and three years respectively. The announcement underscores the urgent need for additional therapies to address AUD and associated organ damage, stressing the necessity for compliance with FDA standards. Eligible small businesses must adhere to strict operational criteria, including ownership, employee count, and structural requirements. The overall goal is to expedite the transition of promising therapeutic candidates through the drug development pipeline towards FDA approval and commercialization.
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