# 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)

Source: https://welltoldgrants.com/grants/par-22-102-investigational-new-drug-ind-enabling-and-early-stage/  
Official notice: https://www.grants.gov/search-results-detail/337461

> National Institutes of Health offered grants to small businesses. Applications closed on December 4, 2024.

| Field | Value |
|---|---|
| Opportunity number | PAR-22-102 |
| Agency | National Institutes of Health |
| Status | Forecast |
| Deadline | December 4, 2024 |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.273 |

## Who can apply

- Small businesses

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.

## What the grant funds

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.

## Questions people ask

### Is PAR-22-102 still open?

No. It closed on December 4, 2024.

### Who can apply for 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)?

National Institutes of Health accepted applications from small businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for 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)?

Closed December 4, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### Who has been funded under PAR-22-102?

NIH RePORTER lists 6 projects funded under PAR-22-102 in fiscal 2023 to 2026, at 6 institutions. The most were at Kuleon LLC, Stress Therapeutics, Inc., Demerx, Inc.

### Who has won Alcohol Research Programs grants before?

The largest recipients over five fiscal years were Yale Univ, University of North Carolina at Chapel Hill, Trustees of Indiana University. The program made 2,255 awards worth $2.2 billion in that time.