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) | PAR 22 102

FAQs: NIH SBIR PAR-22-102 (U43/U44) for AUD and/or AAOD Therapeutic Development

1. What is PAR-22-102 funding intended to support?

PAR-22-102 is a National Institutes of Health (NIH) SBIR funding opportunity designed to help U.S. small businesses advance promising therapeutic candidates for alcohol use disorder (AUD) and/or alcohol-associated organ damage (AAOD) beyond early discovery and into product-oriented development. The goal is to generate the preclinical and, when appropriate, early clinical evidence needed to move toward an FDA Investigational New Drug (IND) application and eventual FDA approval.

2. What kinds of diseases or indications does this program focus on?

The program is focused on therapeutic development for alcohol use disorder (AUD) and/or alcohol-associated organ damage (AAOD). Applications should be tied to one or both of these areas as the central therapeutic target.

3. What does it mean that this is an SBIR opportunity?

This opportunity is under the Small Business Innovation Research (SBIR) program, meaning eligibility is limited to qualifying U.S. small business concerns and the work is positioned as translational, product-directed R&D rather than basic academic research.

4. What award mechanism is used and why does it matter?

The FOA uses a cooperative agreement mechanism (U43/U44). This generally indicates NIH expects to have an active role in the project, with a strong emphasis on clearly defined and measurable milestones and frequent progress checks. Continued support is closely tied to meeting those milestones.

5. Is this program intended for idea-stage projects?

No. Applicants are not expected to apply with only a concept or very preliminary signals. A key requirement is that the applicant has already identified a specific therapeutic candidate and can show a robust body of supporting evidence from basic science and early discovery work.

6. What level of supporting evidence is expected at the time of application?

The FOA describes the starting-line expectations as including a credible scientific foundation and evidence relevant to translational readiness. Examples highlighted include bioactivity and target engagement, reasonable stability, manufacturability (including a plausible path to consistent production), bioavailability, and in vivo efficacy and/or other properties aligned with the intended clinical use.

7. How close to an IND does the project need to be?

The program is meant to push candidates toward an IND application. Projects can cover work from late discovery through IND-enabling studies and, when appropriate, into early-stage human testing. Even if a project does not propose a clinical trial, it is still expected to be driving toward a regulatory pathway and a realistic plan for advancing the candidate toward FDA review.

8. What stages of development are considered responsive to this FOA?

The FOA is deliberately flexible as long as the project falls within a late-discovery through early-clinical window. Eligible activities can start as early as lead optimization and early safety work and can extend through IND-enabling studies and into early-stage clinical trials (if proposed).

9. Are small molecules and biologics treated the same in terms of readiness expectations?

The FOA draws a distinction. For small-molecule drugs, the earliest eligible point is having compounds already in hand with demonstrated pharmacologic activity matching the desired therapeutic effect. For biologics, entry can be earlier, including profiling promising biologic candidates in animal models of AUD or AAOD. In both cases, the bar remains high for readiness and translational potential.

10. What types of activities can the award support?

The FOA supports activities typically needed to reach an IND and begin testing in humans. Examples listed include additional pharmacology, dose-ranging, formulation development, manufacturing and quality planning, and preclinical safety packages aligned with regulatory expectations.

11. Are clinical trials required under PAR-22-102?

No. Early-phase clinical trials are supported but optional. An applicant does not have to propose a clinical trial to be responsive. However, projects without clinical testing are still expected to advance the candidate along a credible regulatory pathway toward FDA review.

12. What does NIH mean by milestone-driven development in this program?

The cooperative agreement structure and the FOA language emphasize clearly defined, measurable milestones and frequent progress checks. Funding decisions and ongoing support are closely tied to whether the project achieves defined development benchmarks that reduce risk and move the therapy toward IND filing and eventual FDA approval.

13. Who is eligible to apply?

Eligibility is limited to U.S. small business concerns applying under the SBIR umbrella.

14. Are foreign organizations eligible to apply as the applicant?

No. Foreign institutions (non-U.S. entities) are not eligible to apply.

15. Can a U.S. small business include non-U.S. components in the project?

Non-domestic components of U.S. organizations are not eligible. However, the FOA notes that foreign components (as NIH defines them in its Grants Policy Statement) may be allowed in certain cases. This typically means discrete parts of the work could potentially be performed abroad if well-justified and compliant with NIH rules.

16. Does NIH encourage applications from any specific types of small businesses?

Yes. NIH explicitly encourages applications from women-owned small businesses and small disadvantaged businesses, reflecting an interest in broadening participation while maintaining strong technical readiness and development plans.

17. What agency is offering this opportunity and what is the program focus area?

The opportunity is offered through the National Institutes of Health (NIH) and is health-focused. The CFDA listing provided is 93.273.

18. What is the listed closing date for this opportunity?

The original closing date listed in the provided information is 2024-12-04.

19. Does the provided information include the maximum award amount or number of awards?

No. The excerpt provided does not specify an award ceiling or the expected number of awards.

20. What is the overall intent or "spirit" of the program?

The intent is practical and translational: advance therapies with a credible scientific foundation out of early discovery and into the preclinical and early clinical development work needed to support an IND and progress toward FDA approval. The program is designed for candidates that are ready to be developed like products, not just explored as research concepts.