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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)

List of required information for application:

1. Identification of a therapeutic candidate for the treatment of alcohol use disorder (AUD) and/or alcohol associated organ damage (AAOD).

2. Robust body of background data in the basic science and early discovery phases.

3. Evidence of bioactivity, stability, manufacturability, bioavailability, in vivo efficacy, and/or target engagement.

4. Proof of desired pharmacological activity for small-molecule compounds or profiling of promising product candidates in animal models for biologics.

5. Description of the project's stage along the drug development continuum (from late discovery to early-stage clinical trials).

6. Milestones proposed to advance the molecules closer to U.S. Food and Drug Administration (FDA) approval.

7. Optional inclusion of early-phase clinical trials in the project proposal.

8. Eligibility as a small business concern (SBC) according to Small Business Innovation Research (SBIR) guidelines.

9. Encouragement for women-owned and Small Disadvantaged small businesses to apply.

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Funding Amount

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Eligible Applicants

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Eligible Activities

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Deadline to Apply

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88%

Approval rating across all Canadian funding programs

93%

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