Nasal Delivery of CNS Therapeutics (R43/R44) | RFA DA 18 006

Opportunity Information: Apply for RFA DA 18 006

The Nasal Delivery of CNS Therapeutics (R43/R44) funding opportunity (RFA-DA-18-006) is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) grant solicitation focused on solving a specific drug delivery problem: getting therapeutically meaningful amounts of medicines into the central nervous system (CNS) using the nasal route. The goal is not simply to show that a compound can be detected in the brain after intranasal dosing, but to develop a nasal delivery formulation and approach that can reliably deliver a therapeutic agent at a physiologically relevant concentration in the CNS, meaning levels that are plausibly high enough and sustained enough to produce a real biological or clinical effect.

In practical terms, the opportunity targets technologies that can overcome the well-known barriers to CNS drug delivery, especially the blood-brain barrier, by leveraging intranasal pathways that may allow more direct access to the brain and cerebrospinal fluid through olfactory and trigeminal nerve-associated routes. NIH is explicitly interested in a wide range of therapeutic modalities, including larger and more delivery-challenged products such as peptides and antibodies, as well as nucleic-acid based approaches like RNA interference (RNAi), and more traditional small-molecule pharmacotherapeutics. That breadth signals that the key innovation is expected to be in the formulation and delivery platform rather than being limited to one drug class, with an emphasis on reproducibility and meaningful CNS exposure.

Because this is an STTR mechanism (R43/R44), the work is intended for small businesses collaborating with a nonprofit research institution, with a structured path from early feasibility through further development. The R43 phase typically supports proof-of-concept and early technical validation, while the R44 phase supports continued development, optimization, and steps that move the technology toward translation. Although the specific milestones and study designs are not listed in the brief text provided, the language around "reliably delivers" and "physiologically relevant concentration" implies that applicants would be expected to generate rigorous evidence around delivery performance, such as quantitative CNS pharmacokinetics, reproducibility across experiments, and data supporting that the achieved CNS levels align with known therapeutic thresholds or pharmacodynamic effects.

Eligibility is limited to small businesses, consistent with the STTR program. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the announcement notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some cases, so applicants would need to justify and document any foreign involvement according to NIH policy and the detailed funding opportunity instructions.

Administrative details from the source information include that the opportunity is categorized as discretionary funding, uses the grant funding instrument, and falls under the Education and Health activity category. The CFDA number associated with this opportunity is 93.279, and the sponsoring agency is NIH. The funding opportunity was created on April 25, 2017, with an original closing date of August 23, 2017. The excerpt provided does not specify an award ceiling or the expected number of awards, so those elements would need to be confirmed in the full announcement text if they are important for planning.

Overall, this RFA is aimed at advancing a practical, translational intranasal delivery solution for CNS therapeutics, with an emphasis on dependable delivery and CNS drug levels that are high enough to matter biologically, developed through a small business-academic partnership structure under the STTR R43/R44 pathway.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Nasal Delivery of CNS Therapeutics (R43/R44)" 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 2017-04-25.
• Applicants must submit their applications by 2017-08-23. (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 18 006

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