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) | RFA HL 26 017

Opportunity Information: Apply for RFA HL 26 017

The NIH National Heart, Lung, and Blood Institute (NHLBI) is offering a Catalyze Program funding opportunity called "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)" (RFA-HL-26-017). The program is built to help move promising basic science discoveries toward real-world therapeutic candidates by providing a structured set of resources and support services that push projects out of the purely academic discovery phase and into early product development. A central theme is translation: helping researchers learn how to think like product developers and entrepreneurs while generating the evidence package needed to make a candidate credible for later-stage development. As written, the endpoint is not human testing under this award, but rather getting projects positioned so they can ultimately be "cleared for human testing" later and, more immediately, ready to meet entry expectations for the NHLBI Catalyze Preclinical Program.

This specific initiative focuses on early-stage translational work for therapeutics and combination products aimed at heart, lung, blood, and sleep (HLBS) diseases and disorders. In practical terms, it supports the work needed to (1) identify and validate a biological target and (2) find and characterize an initial therapeutic concept, such as a preliminary lead series for a small molecule, an early biologic candidate, or a combination product concept. The emphasis on "product definition" signals that NHLBI is looking for projects that go beyond interesting biology and instead begin shaping a development-ready asset: clarifying intended use, defining the target product profile at a high level, generating early evidence that the target is meaningfully linked to disease, and producing initial candidate or lead matter that can be optimized and advanced in subsequent stages. Because this FOA explicitly states "Clinical Trials Not Allowed," supported activities are expected to remain preclinical and translational rather than involving prospective testing in humans.

The award uses an R61/R33 structure, which is typically a phased approach that starts with a milestone-driven early phase (R61) and can transition to a second phase (R33) if predefined scientific and translational benchmarks are met. That design is meant to keep projects moving with clear go/no-go decision points, aligning well with the "de-risking" needs of early therapeutic development. This opportunity is also described as part of a broader Catalyze suite: there is a companion initiative geared toward devices and diagnostics, while this one is oriented toward small molecules, biologics, and combination products. Together, these innovation grants are intended to mature projects until they can credibly enter the NHLBI Catalyze Preclinical Program, which would be a later step on the development pathway.

Eligibility is broad and includes many common U.S. applicant categories such as state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private universities; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant types, 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 agencies, regional organizations, and U.S. territories or possessions. The foreign eligibility language is specific: non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations may apply, and foreign components (as defined by NIH policy) are allowed, which generally means certain project elements may be conducted abroad under a U.S. applicant when justified and compliant with NIH rules.

Administratively, the opportunity is a discretionary grant mechanism under NIH, with health-related activity categories and CFDA numbers listed as 93.233, 93.837, 93.838, and 93.839. The posting indicates an original closing date of 2027-12-23 and a creation date of 2024-11-22. An award ceiling and expected number of awards are not specified in the provided source data, suggesting applicants should consult the full FOA for budget guidance, project period details, and milestone expectations. Overall, the opportunity is best read as a targeted on-ramp for teams that have credible HLBS-relevant biology and want to convert it into an early therapeutic product concept with enough validation and initial lead identification work to justify more intensive preclinical development later.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "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)" 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.
• This funding opportunity was created on 2024-11-22.
• Applicants must submit their applications by 2027-12-23.
• 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.

Apply for RFA HL 26 017

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