Therapeutic Development of Psychoplastogenic Compounds for Substance Use Disorders (R43/R44 - Clinical Trials Not Allowed) | RFA DA 23 017

Opportunity Information: Apply for RFA DA 23 017

The NIH funding opportunity RFA-DA-23-017, titled "Therapeutic Development of Psychoplastogenic Compounds for Substance Use Disorders (R43/R44 - Clinical Trials Not Allowed)," is a discretionary grant program aimed at supporting small business-led research and development of new treatments for substance use disorders (SUD). The focus is specifically on psychoplastogenic compounds, meaning drug candidates that are intended to promote structural and functional neuroplasticity, along with the development or refinement of models that can be used to discover, evaluate, and advance those candidates through the preclinical development pipeline. A key boundary of the program is that alcohol use disorder is explicitly excluded, so the scientific and therapeutic targets should relate to other SUDs (for example, opioid, stimulant, or other drug use disorders) rather than alcohol-related indications.

The mechanism is the NIH Small Business Innovation Research/Small Business Technology Transfer-style pathway using the R43/R44 activity codes, which generally correspond to a phased approach. In practice, applicants typically propose early, proof-of-concept and feasibility work (commonly aligned with Phase I concepts under R43) followed by more advanced research and development activities aimed at de-risking the technology and moving it closer to readiness for later-stage development (commonly aligned with Phase II concepts under R44). Even though the specific phase structure depends on how an application is assembled and justified, the overall intent is to help small businesses move promising psychoplastogenic therapeutic concepts from discovery toward robust preclinical packages that could ultimately support downstream development decisions.

This FOA does not allow clinical trials. That restriction matters because it confines proposed work to non-clinical activities, such as medicinal chemistry and lead optimization; in vitro and in vivo pharmacology; mechanism-of-action studies; development and validation of screening platforms and disease-relevant models; pharmacokinetics and pharmacodynamics; preliminary safety, tolerability, and toxicology-type assessments appropriate for preclinical development; biomarker exploration in non-clinical settings; and other development-enabling studies that strengthen the case for a therapeutic candidate. In other words, the program is designed to fund the discovery and preclinical development runway rather than human testing.

Eligibility is centered on U.S. small business concerns as the primary applicants. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, the announcement notes that foreign components may be allowed as defined under the NIH Grants Policy Statement, meaning a U.S. small business could potentially include certain foreign-based elements in the project when properly justified and compliant with NIH policy, but the applicant organization itself must meet the U.S. small business eligibility requirements.

The administering agency is the National Institutes of Health, and the funding is tied to CFDA number 93.279, which corresponds to NIH research support in the drug abuse area. The original closing date listed for the opportunity was 2022-11-18, and the FOA was created on 2022-06-24, placing it in a specific historical application window. The award ceiling is listed as $2,500,000, indicating the maximum award amount that could be made under this opportunity (with actual award size depending on scope, budget justification, and NIH funding decisions). The notice also lists "Expected Awards" without a specific number provided in the supplied data, which typically means applicants should not assume a guaranteed volume of awards and should rely on the FOA and institute funding plans for any contextual guidance.

Overall, this announcement is best understood as a targeted NIH small business grant opportunity to accelerate preclinical therapeutic development for non-alcohol substance use disorders by leveraging psychoplastogenic mechanisms and by building the experimental models and translational toolsets needed to discover and advance those compounds. It is structured to encourage commercially oriented, development-minded research by small businesses while keeping the work firmly in the non-clinical domain, with the longer-term goal of producing credible drug candidates and validated development approaches that could later support clinical progression through separate, appropriate pathways.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Therapeutic Development of Psychoplastogenic Compounds for Substance Use Disorders (R43/R44 - Clinical Trials 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 2022-06-24.
• Applicants must submit their applications by 2022-11-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA DA 23 017

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