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) | PAR 22 103

Opportunity Information: Apply for PAR 22 103

This opportunity, PAR 22-103, is a National Institutes of Health (NIH) cooperative agreement aimed at helping small businesses push promising treatments for alcohol use disorder (AUD) and/or alcohol-associated organ damage (AAOD) into the kinds of studies the U.S. Food and Drug Administration (FDA) expects before a product can be cleared for marketing. It is structured as a Small Business Technology Transfer (STTR) program, meaning the applicant must be a qualifying U.S. small business and the project is expected to involve a formal collaboration with a research institution partner in the STTR framework. The overall intent is practical and translational: take a therapeutic candidate that already looks credible based on existing evidence and move it closer to IND readiness, early clinical testing, and ultimately FDA approval.

A key requirement is that applicants must come in with a real therapeutic candidate, not just a hypothesis or early exploratory concept. NIH is looking for candidates that already have a solid base of background data from basic science and early discovery work and are ready to transition into preclinical development and, potentially, early-stage clinical evaluation. The FOA highlights the kinds of evidence that help establish readiness, including signs of bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other properties that fit the intended clinical use. In other words, the program is designed for projects that have already cleared the earliest scientific hurdles and now need focused development work to meet regulatory and clinical expectations.

The scope is intentionally broad across the drug development pipeline, but it starts no earlier than late discovery. Projects can begin at lead optimization and early safety work and extend through IND-enabling activities and into early clinical trials. The eligibility threshold differs slightly depending on the type of therapy. For small-molecule drugs, the earliest acceptable starting point is having compounds already in hand with proof of the desired pharmacological activity. For biologics, an acceptable entry point can be profiling promising product candidates in animal models relevant to AUD or AAOD. This signals that NIH is open to multiple therapeutic modalities while still expecting that the project begins with a candidate that has moved beyond purely conceptual or very early screening stages.

The activities supported under this FOA can therefore include the kinds of studies that usually sit between discovery and first-in-human testing, such as additional pharmacology, formulation work, manufacturing and scale-up considerations, and preclinical studies that de-risk the program and support regulatory filings. While the announcement is not limited only to IND-enabling work, it is clearly oriented toward generating decision-grade data and completing defined development steps that make a therapy viable for FDA interaction and eventual approval. The program emphasizes that milestones should be aligned with the proposed stage of development and the overall FDA-facing purpose of the award, so applicants are expected to define concrete, measurable development goals that match where their candidate currently sits.

Early-phase clinical trials are allowed under this announcement but are not required, which gives applicants flexibility. A company that is still assembling an IND package can propose a plan focused on IND-enabling preclinical development, while a company that is ready to move into human testing can propose early clinical work as part of a coherent development path. The "clinical trial optional" framing signals that NIH will consider applications both with and without clinical studies, as long as the project meaningfully advances the candidate toward FDA approval.

On eligibility, this FOA is limited to small businesses as applicants, consistent with STTR requirements, and it explicitly notes that non-U.S. (foreign) institutions are not eligible to apply as the applicant organization. It also states that non-domestic components of U.S. organizations are not eligible to apply, though foreign components may be allowable under NIH policy definitions in some circumstances. The FOA also encourages applications from women-owned and Small Disadvantaged small businesses, indicating a priority for broad participation among eligible U.S. small business innovators.

Administratively, the opportunity is categorized as discretionary funding and uses a cooperative agreement mechanism, which typically means NIH expects more substantial programmatic involvement than in a standard grant. The assistance listing (CFDA) number is 93.273. The posting indicates an original closing date of 2024-12-04 and a creation date of 2022-01-21. While the source text does not specify an award ceiling or the number of expected awards, the program description makes clear that awards will be driven by the appropriateness of the proposed development plan and the alignment of project milestones with the FOA's goal of advancing viable therapeutic candidates toward FDA approval for AUD and AAOD.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "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)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
• This funding opportunity was created on 2022-01-21.
• Applicants must submit their applications by 2024-12-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 22 103

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: