Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (U44 - Clinical Trial Optional) | PAR 18 578

Opportunity Information: Apply for PAR 18 578

The grant opportunity titled "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol-related Disorders (U44 - Clinical Trial Optional)" is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program run under the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It is published as Funding Opportunity Number PAR-18-578 and uses the cooperative agreement mechanism (U44), which generally means the NIH expects to have a more hands-on scientific or programmatic role than with a standard grant. The overall purpose is to help small businesses push promising medication candidates for alcohol use disorder (AUD) and alcohol-related disorders through the critical IND-enabling stage, with the clear expectation that the work will be mature enough by the end of the award to support submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). In other words, this is not a discovery-stage or early hit-finding program; it is aimed at projects that already have a defined therapeutic candidate and are ready to do the set of studies needed to justify first-in-human testing.

A central requirement of this FOA is that applicants must come in with an "identified candidate" rather than a general platform or a broad set of leads. That candidate is expected to already show convincing properties aligned with the intended clinical use, such as adequate bioactivity (the drug does what it is supposed to do), stability (it does not degrade too quickly), manufacturability (it can be made reliably and at usable scale), and bioavailability (it can reach the body compartment where it needs to act). The announcement also highlights the importance of in vivo efficacy and/or target engagement, meaning the candidate should have evidence from animal models or other relevant systems that it either produces the desired therapeutic effect or demonstrably interacts with its biological target in a way consistent with the proposed mechanism. These expectations are meant to ensure the project begins at a stage where IND-enabling work is realistic within the award period.

The main activities supported are IND-enabling studies, which typically include the nonclinical safety and toxicology package (often conducted under Good Laboratory Practice conditions when appropriate), pharmacology and pharmacokinetics work to characterize exposure and dose relationships, and chemistry, manufacturing, and controls (CMC) tasks needed to produce a drug substance and drug product suitable for clinical use. While the FOA text provided does not enumerate each study type, the stated endpoint makes the intent clear: the funded work should be sufficient to compile an IND submission to FDA. The benchmark for success is therefore not just publishing data or demonstrating feasibility, but reaching a regulatory milestone that opens the door to clinical testing.

Although the U44 mechanism is labeled "Clinical Trial Optional," the opportunity explicitly notes that early-phase clinical trials are supported but not required. That means a project can be structured to stop at IND submission, or, if the development program is far enough along and justified, the award can also cover initial human studies (typically Phase 1 and potentially small early Phase 2-style efforts) aimed at establishing safety, tolerability, pharmacokinetics, and early signals of efficacy or target engagement in people. The optional nature of clinical trials is important for companies whose development timeline may not allow a clinical start within the award window but who can credibly reach IND submission.

Eligibility is limited to small business concerns, consistent with SBIR requirements. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply under this opportunity. However, the FOA notes that "foreign components" as defined under the NIH Grants Policy Statement may be allowed, which usually refers to specific elements of a project being conducted outside the U.S. when there is a strong scientific justification and NIH policies are met. In practical terms, the applicant organization must be U.S.-based and eligible as an SBIR small business, but certain narrowly defined activities might still be permissible abroad if properly justified and approved.

Administratively, the opportunity is categorized as discretionary funding, uses the health activity category, and is associated with CFDA number 93.273. The original closing date listed in the provided data is 2021-03-25, and the opportunity record shows a creation date of 2018-01-12. The excerpt does not provide an award ceiling or expected number of awards, so applicants would typically look to the full FOA and NIH SBIR budget guidelines for limits, milestones, and cost expectations. Overall, this funding announcement is best understood as a translational, preclinical-to-early-clinical bridge for small businesses that already have a credible medication candidate for AUD or alcohol-related disorders and need resources and NIH partnership to complete the IND-enabling package and, at minimum, submit an IND to FDA by the end of the project.

• 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 (U44 - 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.

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