Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed) | RFA DA 22 023

Opportunity Information: Apply for RFA DA 22 023

The funding opportunity titled "Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) small business grant solicitation designed to move promising, well-supported drug targets for substance use disorders (SUDs) closer to the clinic. It uses the SBIR/STTR-style phased mechanism (R43/R44), which generally supports early-stage feasibility and development work in small business concerns, with the intent of advancing translational projects that have already cleared an important hurdle: the target is robustly validated. In other words, this program is not meant for speculative target discovery. It is meant for projects where the biological rationale is strong enough that the next logical step is to build the tools, compounds, and preclinical package needed to justify eventual human testing.

A central focus of this FOA is helping small businesses progress along the early drug development pipeline for SUD therapeutics. The announcement explicitly supports projects that enter at key preclinical stages: assay development (AD), lead identification (LI), lead optimization (LO), or preclinical development (PCD). That scope covers a broad span of work, from building and validating the screening assays that will be used to find or characterize compounds, through identifying initial chemical or biologic leads, improving those leads to achieve better potency, selectivity, and drug-like properties, and then completing the kinds of preclinical development studies that typically position a program for Investigational New Drug (IND)-enabling activities. The practical intent is to de-risk the program scientifically and technically so that, after this funding, the project is closer to meeting the evidence expectations for an IND submission pathway, even if the FOA itself is not paying for clinical testing.

The FOA is clear that clinical trials are not allowed under this solicitation. That means the supported research should remain on the preclinical side, such as in vitro studies, nonclinical in vivo pharmacology where appropriate, medicinal chemistry and optimization, ADME/PK profiling, early safety or tolerability assessments that do not constitute human trials, and other development tasks that build a credible dossier for later regulatory interactions. The end goal is not to run a clinical trial within the grant period, but to generate the validated assays, optimized leads, and preclinical evidence base that can justify and support the next translational leap.

Eligibility is intentionally narrow and oriented around U.S. innovation via small businesses. The eligible applicants are small business concerns, aligning with the R43/R44 mechanism and NIH's small business translational mission. The solicitation also specifies important restrictions related to foreign participation: non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, it notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed, which typically means limited, well-justified work performed outside the U.S. can sometimes be included as a component of a domestic application when it provides a unique resource, expertise, population, or capability that cannot be readily obtained in the U.S., and when it is consistent with NIH policy and program goals.

From the source details, this is a discretionary grant opportunity under the NIH, with the funding activity categorized under education and health, and associated with CFDA number 93.279. The opportunity number is RFA-DA-22-023, indicating it is an RFA issued within NIDA's domain (the DA prefix is commonly associated with the National Institute on Drug Abuse). The original closing date listed is February 18, 2022, and the record creation date is July 29, 2021. While the provided data do not specify an award ceiling or the expected number of awards, the purpose and structure suggest competitive, milestone-driven translational awards typical of NIH small business programs, where applicants are expected to present a coherent development plan, clear go/no-go criteria, and strong evidence that the target and approach are sufficiently validated to warrant product-focused investment.

Overall, the opportunity is best understood as a push to convert validated SUD biology into tangible therapeutic candidates by funding practical drug development steps inside small businesses. It aims to help applicants build credible assays, discover and refine leads, and assemble the preclinical development package that positions a project to complete IND-enabling work and ultimately enter clinical evaluation later, outside the scope of this specific "clinical trial not allowed" FOA.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2021-07-29.
• Applicants must submit their applications by 2022-02-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA DA 22 023

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