NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) | PAR 25 025

Opportunity Information: Apply for PAR 25 025

The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) funding opportunity (PAR 25-025) is an NIH grant program designed to support investigator-initiated Phase I clinical trials that test new therapeutics and/or diagnostics for heart, lung, blood, and sleep (HLBS) disorders in both adults and children. The core aim is to help move promising early-stage interventions into first-in-human or other Phase I settings where the primary emphasis is on early safety, tolerability, dosing, feasibility, and other foundational clinical data needed to decide whether an intervention should advance to later-phase testing. Trials may be designed as single-site or multi-site studies, giving applicants flexibility to match the footprint of the study to the condition, target population, recruitment needs, and operational realities.

A defining feature of this R33 clinical trial mechanism is the expectation of immediate trial readiness. Applicants are expected to be prepared to initiate the clinical trial within the first quarter of the project period, which effectively means the work proposed should be beyond basic startup planning and close to enrolling participants soon after award. In practical terms, the program is intended for teams that already have their protocol substantially finalized and the operational pieces lined up so the study can begin quickly. The notice stresses that key regulatory and oversight milestones should be in place by the time the award is made. That includes having had the necessary discussions and submissions to regulators as applicable (for example, FDA interactions for IND/IDE-related work when required), as well as having required approvals and oversight structures aligned, such as Institutional Review Board (IRB) review and Data and Safety Monitoring Board (DSMB) arrangements when appropriate for the risk level and design. It also highlights the expectation that drug supply logistics (and placebo supply, if relevant) and any needed third-party agreements (such as contracts with manufacturers, central laboratories, imaging core facilities, clinical research organizations, or collaborating sites) are established by award, rather than being treated as early-year activities.

This NOFO is positioned specifically for groups that do not need substantial preclinical development time or extensive clinical trial readiness work during the award period. If an applicant still needs time, funding, or structured support to complete enabling activities before a Phase I trial can responsibly begin, the opportunity directs them to consider a companion announcement using an R61/R33 phased approach. That alternative structure is typically used when there is a clear pathway to a clinical trial but remaining milestones must be achieved first (for example, final formulation work, device refinement, completion of key toxicology, finalization of manufacturing, or other readiness tasks) before transitioning into the clinical trial phase.

Eligibility is broad and includes a wide range of domestic organizations and governmental entities. Eligible applicants include state, county, city/township, and 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 (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments, along with tribal organizations that are not federally recognized tribal governments. The NOFO also explicitly calls out 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, reflecting NHLBI and NIH interests in broad participation across institution types and communities.

The policy on foreign participation is specific. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement. In other words, a U.S.-based applicant can include certain foreign components or activities when well-justified, but a foreign organization cannot be the primary applicant.

From the funding metadata provided, this is a discretionary grant program under NIH with Health as the activity category, tied to CFDA numbers 93.233, 93.837, 93.838, and 93.839. The listed award ceiling is $1,515,000, and the opportunity’s original closing date is January 7, 2027. Overall, the opportunity is best suited to well-prepared teams with a clearly defined Phase I clinical trial in HLBS conditions, a near-launch-ready study package, and the regulatory, oversight, supply chain, and contracting elements sufficiently mature to begin the trial quickly after funding starts.

• 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 (R33 CT 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.
• This funding opportunity was created on 2024-12-05.
• Applicants must submit their applications by 2027-01-07.
• Each selected applicant is eligible to receive up to $1,515,000.00 in funding.
• 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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