Lead Optimization and Pre Clinical Development of Therapeutic Candidates for Diseases of Interest to the NIDDK (SBIR (R43/R44)) | Apply Online

Opportunity Summary:

This grant opportunity (PA 14-055) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program announcement from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Its core purpose is to move promising therapeutic ideas beyond early discovery and into the more demanding stages of lead optimization and preclinical development, specifically for diseases that fall within NIDDKs mission areas such as diabetes and other endocrine/metabolic disorders, digestive diseases, and kidney and urologic diseases. Rather than funding broad basic research, the FOA is geared toward projects that can show a practical development path, with the expectation that funded work will de-risk a candidate enough to support regulatory advancement.

The announcement is structured around the SBIR phased approach using the R43 (Phase I) and R44 (Phase II) mechanisms. Phase I funding is intended to support the earlier, enabling steps that prepare a program for true development work. In practice, that can include initial lead optimization activities (for example, improving potency, selectivity, stability, or formulation characteristics), early proof-of-concept studies, or targeted preclinical experiments that establish feasibility and inform a rational development plan. The idea is that Phase I should generate enough credible data to justify selecting or refining a lead candidate and to lay out a development strategy that can realistically succeed in Phase II.

Phase II is designed to carry the project through more substantial lead optimization and preclinical development activities focused on producing an advanced lead candidate suitable for regulatory submission. A key feature of this FOA is the expectation that by the end of a Phase II or Phase IIB effort, the project will be far enough along that the small business can submit an Investigational New Drug (IND) application or, for device-based therapeutics where applicable, an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA). This means the proposed Phase II work should not be exploratory in a general sense; it should be organized around the concrete studies, documentation, and decision-making needed to reach an IND/IDE-ready state, such as definitive candidate selection, required preclinical packages, and plans consistent with FDA expectations.

A major requirement emphasized in the announcement is the use of clear, predefined milestones and timelines. Applicants are expected to present a development plan that reads like a disciplined product development program, not an open-ended research project. That includes identifying specific go/no-go decision points that determine whether the project advances, pivots, or stops based on objective criteria. In other words, the FOA is looking for proposals where success can be measured, progress can be tracked against a schedule, and critical risks are explicitly addressed with decision gates. This milestone-driven structure is meant to ensure that the work stays focused on advancing a therapeutic candidate toward clinical readiness and that federal funds support projects with a credible path to a meaningful translational endpoint.

Eligibility is limited to small businesses, consistent with SBIR rules. Foreign entities (non-U.S. institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some cases, which typically means discrete project elements can be performed abroad if they are well justified and compliant with NIH policy. The opportunity does not require cost sharing or matching funds. The program is categorized under a discretionary grant funding instrument, with the associated CFDA number 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). The announcement was posted on January 2, 2014, and the final listed closing date was January 7, 2017, with an archive date of February 7, 2017, indicating the specific announcement is no longer active but remains available for reference.

For applicants and interested parties, NIH provided an official additional information link to the full FOA text hosted on the NIH grants guide site, and general technical access or linking issues were directed to the NIH Office of Extramural Research (OER) webmaster. Overall, the opportunity is best understood as a translational SBIR pathway for small companies that already have a therapeutic concept with early supporting data and are prepared to execute a milestone-based plan that ends with an IND or IDE submission readiness milestone, positioning the program to enter human testing or device clinical evaluation.

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Previous opportunity: Lead Optimization and Pre Clinical Development of Therapeutic Candidates for Diseases of Interest to NIDDK (STTR (R41/R42))

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