Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed) | RFA HL 20 027

Opportunity Information: Apply for RFA HL 20 027

Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed) (RFA-HL-20-027) is a discretionary NIH grant opportunity run by the Department of Health and Human Services through the National Heart, Lung, and Blood Institute (NHLBI). It is designed to fund early translational work that bridges the gap between basic discovery and a credible, development-ready therapeutic concept. The central aim is to help teams identify and define a promising lead compound or lead series (for small molecules or biologics) that could ultimately become a therapy for heart, lung, blood, or sleep-related diseases and disorders. Importantly, this FOA is not intended to support clinical trials; it focuses on the preclinical, product-definition stage where a candidate is still being selected and shaped.

This FOA sits inside NHLBI's broader Catalyze innovation grant suite, which is meant to move promising ideas to a point where they either (a) meet the entry criteria for the NHLBI Catalyze Preclinical program, or (b) are sufficiently de-risked to attract outside development support from other federal programs or private-sector partners. In practical terms, the program is trying to take projects that may have strong scientific rationale but are not yet "drug development-ready" and fund the structured experiments and decision-making needed to identify a tractable lead and a clearer path toward preclinical optimization.

The funded work is centered on preliminary product/lead series identification, meaning applicants are generally expected to propose a plan for selecting and prioritizing one or more candidate molecules or biologic leads based on evidence and well-defined criteria. While the FOA text provided here is brief, the phrase "product definition" typically implies activities like refining a target product profile, establishing or improving assay systems, performing initial structure-activity relationship exploration for small molecules or early engineering/selection steps for biologics, and generating early proof-of-concept data in relevant experimental systems. The endpoint is usually a justified lead series with enough supporting data to make a credible case for moving into more formal preclinical optimization and development, rather than open-ended discovery research.

The opportunity uses the R33 activity code, which is commonly associated with milestone-driven translational projects and later-stage exploratory development rather than hypothesis-only research. The "Clinical Trial Not Allowed" restriction is explicit: projects must stay on the non-clinical side and should not propose human subjects clinical trials as part of the work supported under this award. Applicants should therefore frame their plans around preclinical feasibility, lead selection, and early development decisions, not clinical testing.

Eligibility is broad and includes many organizational types across academia, government, nonprofit, and industry. Eligible applicants include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (including those other than small businesses); small businesses; and additional categories as described in the FOA's eligibility clarification text. This wide eligibility aligns with the translational focus, where promising therapeutic programs may originate in universities, startups, established companies, or mission-driven nonprofits.

From a funding standpoint, the award ceiling is listed as $350,000, with an expected 13 awards. The opportunity was created on September 9, 2019, and the original closing date was August 11, 2021. The program is associated with multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting its placement within NIH/NHLBI funding streams that support cardiovascular, pulmonary, hematologic, and sleep research and related translational efforts.

Overall, the grant is best understood as a catalytic push for teams that have a compelling therapeutic concept but need focused translational support to identify a real lead series and define a plausible development path. The intended outcome is not a finished preclinical package and not any clinical testing, but a well-supported lead candidate direction that can graduate into more intensive preclinical development programs or become attractive to co-development partners and investors.

• The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on Sep 09, 2019.
• Applicants must submit their applications by Aug 11, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $350,000.00 in funding.
• The number of recipients for this funding is limited to 13 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA HL 20 027

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