Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 -Clinical Trial Optional) | PAR 18 580

Opportunity Information: Apply for PAR 18 580

The grant opportunity PAR 18 580, titled "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol-related Disorders (UT2 - Clinical Trial Optional)," is a National Institutes of Health (NIH) funding program run under the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It is designed specifically for small businesses applying through the Small Business Technology Transfer (STTR) mechanism, with funding issued as a cooperative agreement. That cooperative agreement structure typically means the NIH program staff expect to have an active role during the project period, providing substantial scientific or programmatic involvement beyond what is common in a standard grant.

The main purpose of this opportunity is to push promising therapeutic candidates far enough along the development pathway to support submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). In practical terms, this is a translational "late preclinical" development program focused on generating the package of data and documentation that FDA expects before a drug can legally begin clinical testing in humans in the United States. The FOA is not meant for basic discovery or early hit identification. Instead, applicants must already have an identified therapeutic candidate in hand before they apply. That candidate is expected to have a credible foundation of properties that match the intended clinical use, including evidence of bioactivity, acceptable stability, feasibility of manufacturing, and favorable bioavailability. The candidate should also have meaningful in vivo efficacy data and/or clear target engagement evidence, along with other characteristics that support further development toward human use.

Projects funded under this FOA are expected to focus on IND-enabling studies. While the announcement does not list every required experiment in the excerpt provided, IND-enabling work generally includes activities like scale-up or process development for manufacturing, analytical method development, formulation work, stability testing, and nonclinical safety studies conducted in a way that can support regulatory review. The overarching theme is that the work should be organized around the concrete regulatory milestone of filing an IND. The FOA is explicit about the end-of-project expectation: a successful award should result, at a minimum, in an IND application being submitted to FDA by the end of the funding period.

Although the program is anchored in IND-enabling development, it also allows (and supports) early-phase clinical trials, but it does not require them. This "clinical trial optional" feature means a project can be structured either as preclinical IND-enabling only, or as a program that moves into initial human testing if the timelines, data readiness, and regulatory positioning make that feasible. In either case, the central deliverable remains IND submission, with clinical work framed as an optional extension rather than the baseline requirement.

Eligibility is narrowly targeted. The eligible applicant category is small businesses, consistent with the STTR mechanism. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, the FOA notes that "foreign components," as defined under the NIH Grants Policy Statement, may be allowed. In NIH terms, that typically refers to discrete elements of a project performed outside the U.S. under specific justification and compliance conditions, rather than the entire applicant organization being foreign-based.

Administratively, the opportunity is categorized as discretionary funding and falls under the health activity category, with CFDA number 93.273. The original closing date shown is March 25, 2021, and the FOA was created on January 12, 2018. The excerpt does not provide an award ceiling amount or the expected number of awards, which suggests applicants would need to consult the full FOA text or related NIH documentation for budget limits, project period expectations, and detailed review criteria.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (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 2018-01-12.
• Applicants must submit their applications by 2021-03-25. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 18 580

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