Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allow
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 support needed 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 initiative supports early-stage translational researchers and entrepreneurs seeking to advance basic science discoveries into viable diagnostic and therapeutic candidates for heart, lung, blood, and sleep (HLBS) diseases and disorders. This grant program is designed for researchers and innovators working with small molecules, biologics, and combination products who need comprehensive support to identify and characterize potential therapeutic candidates before clinical testing. The program provides essential resources to help researchers develop product definitions, conduct preliminary studies, and create combination product prototypes that meet entry criteria for subsequent NHLBI programs. Applicants should have promising scientific discoveries ready for the transition from bench to clinic. This initiative is particularly valuable for translational researchers looking to build entrepreneurship and product development expertise while advancing their therapeutic candidates toward human testing approval. The program welcomes applications from diverse institutions, including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations. If you have early-stage HLBS-related therapeutic discoveries and seek structured support for product development and characterization, this grant may accelerate your path to clinical viability.
Funding Facts
● Applications openDeadline
December 23, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle
Deadline
2027-12-23
Grant Type
federal
Application Cycle
Annual
Best For
Early-stage translational researchers, small molecule and biologics developers, minority-serving institutions, community-based organizations working on HLBS disease therapeutics
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 the Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products grant?
Eligible applicants include 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), and Indian/Native American Tribal Governments. For a complete and current list of eligible institution types, visit the official NHLBI Catalyze Program website.
How much funding does the Catalyze: Product Definition grant provide?
Specific funding amounts are not listed in the current available information. Funding varies by grant cycle and project scope. Visit the official NHLBI grant announcement or contact the NHLBI directly for current funding ranges and budget details.
How do I apply for the Catalyze: Product Definition grant?
Applications are submitted through the official NHLBI grants submission process. Applicants should review the detailed funding opportunity announcement on the NHLBI website for specific submission requirements, formatting guidelines, and required documentation. The deadline for this cycle is December 23, 2027. Consult the official website for application instructions and any pre-submission requirements.
What can Catalyze: Product Definition funding be used for?
This grant supports early-stage translational research activities including preliminary product definition, lead series identification, and combination product prototype development for HLBS (heart, lung, blood, and sleep) diseases and disorders. Funding enables researchers to characterize therapeutic candidates, conduct foundational studies, and develop the product definitions needed to transition from basic science discoveries toward clinical readiness. Clinical trials are not permitted under this award mechanism.
Last updated: July 5, 2026