Catalyze: Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed) | RFA HL 23 011

Opportunity Information: Apply for RFA HL 23 011

The NIH, through the National Heart, Lung, and Blood Institute (NHLBI), is offering a Catalyze Product Definition funding opportunity focused on very early translational work for therapeutics addressing heart, lung, blood, and sleep diseases and disorders. The program is designed to help teams move from basic scientific insight toward a credible, characterized therapeutic concept by supporting two key stages: (1) target identification and validation and (2) preliminary product or lead series identification for either small molecules or biologics. The intent is to generate the kind of evidence package that makes a project "real" from a development standpoint, positioning it to either enter the NHLBI Catalyze Preclinical program later or to attract follow-on support from other federal programs or private partners for preclinical optimization and development.

This opportunity uses an R61/R33 phased award structure and explicitly does not allow clinical trials. In practice, that means the first phase (R61) is meant to get a project through defined early milestones, and the second phase (R33) continues support if those milestones are met, enabling a more advanced but still preclinical set of activities. The overall emphasis is on product definition: clarifying the therapeutic hypothesis, building confidence in the biological target, and identifying initial candidate molecules or lead series that could plausibly be optimized into a development-ready therapeutic. While the notice does not list specific scientific requirements in the excerpt provided, the title and description make clear that fundable work centers on establishing a defensible target and producing early candidate matter (for example, initial leads, prototypes, or candidate biologic constructs) rather than later-stage IND-enabling studies or any human testing.

The FOA sits within the broader NHLBI Catalyze suite of innovation grants. Conceptually, Catalyze is trying to bridge a common gap between discovery research and formal preclinical development by providing resources, structure, and translational expectations earlier than many traditional investigator-initiated grants. The deliverable mindset is important here: projects should be aiming to produce decision-quality data and tangible outputs that let an external partner or a downstream preclinical program evaluate whether the therapeutic concept is ready for the next step.

Eligibility is broad and includes many common U.S. applicant categories such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses. It also includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), as well as public housing authorities/Indian housing authorities. The announcement also highlights additional eligible applicant types that NIH specifically calls out, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, and U.S. territories or possessions.

On foreign participation, the rules are fairly typical for NIH: non-U.S. organizations as direct applicants (foreign institutions) are not eligible to apply. However, non-domestic components of U.S. organizations are allowed to apply, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed as part of an otherwise eligible application. This structure is meant to keep the prime award primarily within eligible U.S.-based entities while still permitting justified international collaboration or subcontracted work when it strengthens the project.

Key administrative details from the listing include the Funding Opportunity Title "Catalyze: Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed)," the Funding Opportunity Number RFA-HL-23-011, and the agency as the National Institutes of Health. The opportunity is categorized as a discretionary grant in the health area, with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840 associated with the program areas. The original closing date shown is 2024-12-20, and the creation date is 2022-01-24. The excerpt does not provide an award ceiling amount or expected number of awards, so those details would need to be confirmed in the full FOA text or on the NIH funding announcement page.

Overall, the best fit for this FOA is a therapeutic project that is still early but ready to be shaped into a development-oriented plan: the biological rationale is promising, the target can be validated with credible experiments, and there is a clear path to identifying an initial small-molecule lead series or a preliminary biologic candidate. The program is essentially trying to help applicants convert strong science into a defined therapeutic starting point that can survive the scrutiny of later preclinical development and external investment, without moving into clinical research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials 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 2022-01-24.
• Applicants must submit their applications by 2024-12-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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