NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required) | PAR 25 026

Opportunity Information: Apply for PAR 25 026

The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required) funding opportunity (PAR 25 026) is a National Institutes of Health discretionary grant program designed to move promising heart, lung, blood, and sleep (HLBS) innovations into first-in-human testing. The central purpose is to support investigator-initiated Phase I clinical trials of both therapeutics and diagnostics intended for HLBS disorders, and it explicitly allows studies in both adult and pediatric populations. The program is built to help teams get from a late preclinical, trial-ready state to an initiated and executed early clinical trial, including the practical work that often blocks timely trial launch.

A key feature of the opportunity is its two-phase, milestone-driven structure using the R61/R33 mechanism. The R61 phase functions as a preparatory stage that funds the final steps needed to make the proposed intervention ready for clinical use and to ensure the trial can start cleanly. This phase can cover late-stage preclinical and operational activities such as product stability work, packaging and shipping studies, and site qualification and training, as long as every R61 activity is directly tied to preparing the specific therapeutic or diagnostic for the planned clinical trial. The intent is not to support broad discovery or unrelated development tasks, but rather the concrete, deliverable steps that reduce risk and enable a compliant Phase I study to begin.

The R33 phase supports the actual clinical trial start-up and implementation once predefined milestones are met. Because the award is milestone-based, applicants are expected to propose clear, measurable go/no-go benchmarks that demonstrate readiness to transition from preparation into enrollment and trial execution. The clinical trial itself may be conducted at a single site or across multiple sites, giving applicants flexibility to match the design to the target condition, recruitment realities, and the operational needs of the intervention.

In terms of who can apply, eligibility is broad and includes many types of U.S. organizations and governmental units, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and federally recognized Native American tribal governments. The program also allows applications from tribal organizations that are not federally recognized tribal governments, 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 announcement also highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities.

Administrative details from the source include that the sponsoring agency is the NIH, the funding instrument is a grant, and the activity category is health. The opportunity is associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The opportunity record shows a creation date of 2024-12-05 and an original closing date of 2027-01-07. Award ceiling and expected awards are not specified in the provided listing, which generally means applicants should consult the full announcement for budget guidance, limits, and NHLBI expectations for scope and cost.

Overall, this NOFO is aimed at applicants who already have a therapeutic or diagnostic that is sufficiently advanced to justify a Phase I clinical trial and who can lay out a realistic, milestone-based plan to finish any final pre-trial requirements quickly, then execute a well-designed early-phase clinical study in an HLBS population.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)" 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 2024-12-05.
• Applicants must submit their applications by 2027-01-07.
• 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 PAR 25 026

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