Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed)

Background
The NHLBI Catalyze Program aims to support the transition of basic science discoveries into viable diagnostic and therapeutic candidates cleared for human testing. This specific initiative focuses on providing early-stage translational support for identifying and characterizing potential therapeutic candidates and combination products for heart, lung, blood, and sleep (HLBS) diseases and disorders. The program also seeks to develop researchers skilled in product development and entrepreneurship.

Grant Details
The R61 phase involves identifying, validating, and screening therapeutic compounds of interest. The R33 phase focuses on identifying promising lead compounds for pre-clinical testing. Activities include synthesis of novel therapeutic agents, development of assays to measure specificity and potency, structure-activity relationship studies, and validation studies. The R33 phase includes activities such as characterization of therapeutic agents, assessment of pharmacokinetic parameters in animal models, and validation studies to confirm results. Projects must demonstrate a robust data set that can attract further funding for preclinical optimization.

Eligibility Requirements
Eligible applicants include higher education institutions (public or private), nonprofits, for-profit organizations (including small businesses), local/state governments, tribal governments, federal agencies, and other organizations. Institutions serving underrepresented groups are encouraged to apply. Non-domestic entities are not eligible.

Period of Performance
The maximum project period is three years, with up to two years allocated for each phase (R61 and R33). The phases cannot be awarded in the same fiscal year.

Grant Value
NHLBI intends to commit total costs of up to $4,466,000 annually for FY 2026 through FY 2028. Each application budget must not exceed direct costs of $400,000 per year during both the R61 and R33 phases.