Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trial
About
The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative will provide the early stage translational supportneeded for the activities required to identify and characterize potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This initiative has a companion initiative that supports development of devices and diagnostics and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.
The NHLBI Catalyze: Product Definition program is designed for translational researchers, academic institutions, and organizations developing small molecule drugs, biologics, and combination products to treat heart, lung, blood, and sleep (HLBS) diseases and disorders. This grant funds early-stage translational support for target identification, validation, and preliminary product/lead series identification—the critical steps between basic science discovery and clinical trial readiness. Researchers and entrepreneurs should apply if they have promising basic science discoveries that need support to advance toward viable diagnostic and therapeutic candidates suitable for human testing. The program aims to develop translational researchers with expertise in both product development and entrepreneurship, filling a vital gap in the drug development pipeline. Eligible applicants include HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based and community-based organizations, and other eligible federal agencies. This is part of a broader NHLBI innovation grant suite designed to advance projects to meet entry criteria for the Catalyze Preclinical Program. If you have groundbreaking research with therapeutic potential, this grant provides the structured support and expertise needed to navigate the complex path toward clinical development.
Funding Facts
● Applications openDeadline
December 23, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by funding cycle
Deadline
2027-12-23
Grant Type
federal
Application Cycle
Annual cycle (Deadline: December 23, 2027)
Best For
Academic institutions, HBCUs, minority-serving institutions, translational researchers with HLBS-focused drug discovery projects
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Govern
Frequently Asked Questions
Who is eligible for Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33)?
Eligible applicants include Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander serving institutions (AANAPISIs), eligible federal agencies, faith-based and community-based organizations, Hispanic-serving institutions, and Historically Black Colleges and Universities (HBCUs). For a complete list of eligible entity types and specific requirements, visit the official NHLBI website or grants.nih.gov.
How much funding does this Catalyze Product Definition grant provide?
Specific funding amounts vary by funding cycle. For current information on award ranges and budget limitations for this R61/R33 initiative, consult the official NHLBI Catalyze program website or NIH grants portal.
How do I apply for Catalyze: Product Definition for Small Molecules, Biologics and Combination Products?
Applications are submitted through grants.nih.gov using the NIH GUIDES for Grant and Contract Submissions. You will need an active institutional account and DUNS number. The application requires a detailed research plan describing your target identification, validation, and preliminary product development strategy for HLBS disease treatment. Visit the official NHLBI Catalyze program page for specific submission guidelines, required forms, and the current application deadline.
What can Catalyze: Product Definition funding be used for?
Funding supports early-stage translational research activities including target identification and validation for small molecules, biologics, and combination products designed to treat HLBS diseases and disorders. Supported activities include preliminary product and lead series identification, feasibility studies, and translational research needed to characterize potential therapeutic candidates for advancement toward human clinical trials. Funds may also support researcher development in product development and entrepreneurship.
Last updated: July 5, 2026