PAR-22-102: 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
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2022.
National Institutes of Health offered grants to small businesses. Applications closed on December 4, 2024.
From the official notice on Grants.gov, last changed January 21, 2022. Checked November 7, 2026.
- Award amountsNot given on Grants.gov
- Cost sharingNot required
- Funding typeCooperative Agreement
About this NIH notice
- Activity codeU43 / U44
- Clinical trialsOptional
- Funded byNIAAA
- Median yearly award$995,176
- Typical project length2 years
Projects funded under PAR-22-102 were run by National Institute on Alcohol Abuse and Alcoholism (NIAAA, 6 projects). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read PAR-22-102 in the NIH Guide.
Key dates
| Posted | January 21, 2022 |
|---|---|
| Deadline | December 4, 2024 |
| Archived by Grants.gov | January 9, 2025 |
Who can apply
This opportunity was open to small businesses.
- 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.
Is this a realistic fit?
- Most of the program's money (73% over five years) went to colleges and universities.
- No cost sharing or match is required.
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.
Funded under PAR-22-102 so far
NIH funded 6 projects under PAR-22-102 in fiscal 2023 to 2026, at 6 institutions. The median yearly award was $995,176.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| Novel and functionally selective 5-HT2C receptor agonist for treating Alcohol Use Disorder | Kuleon LLC | 2026 | $1.0 million |
| Investigational New Drug (IND)-enabling Study for a New Therapeutic for Alcohol Use Disorder (AUD) | Stress Therapeutics, Inc. | 2026 | $995,447 |
| Investigational New Drug Development of Noribogaine for Alcohol Use Disorder | Demerx, Inc. | 2026 | $796,298 |
| Preclinical validation of mGlu2 PAMs in alcohol use disorder | Camino Pharma, LLC | 2024 | $994,906 |
| Development of a Novel Medication for Alcohol Use Disorder with an Active IND Dual Inhibitor of T-Type Calcium Channel and Soluble Epoxide Hydrolase | Afasci, Inc. | 2024 | $498,851 |
| Investigational New Drug (IND)-enabling and Early-Stage Development of Selective, Reversible, Orally Bioavailable ALDH2 inhibitor ANS-00858 to Treat Alcohol Use Disorder. | Amygdala Neurosciences, Inc. | 2024 | $1.0 million |
Who has won Alcohol Research Programs grants before
From fiscal 2021 to 2025, Alcohol Research Programs (93.273) awarded $2.2 billion across 2,255 grant awards, an average of $974,579 per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| Yale Univ | Connecticut | 75 | $86.5 million |
| University of North Carolina at Chapel Hill | North Carolina | 76 | $60.7 million |
| Trustees of Indiana University | Indiana | 47 | $54.8 million |
| University of California, San Diego | California | 47 | $54.5 million |
| The Medical University of South Carolina | South Carolina | 57 | $45.8 million |
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
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.
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