NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
Supporting early phase clinical trials for heart, lung, blood, and sleep disorders in both adults and children, with applicants expected to be ready to start trials within the initial project period.
Funder: National Institutes of Health
Due Dates: June 4, 2025 (New/Renewal/Resubmission/Revision) | September 7, 2025 (AIDS) | October 2, 2025 (New/Renewal/Resubmission/Revision) | January 7, 2026 (AIDS) | February 3, 2026 (New/Renewal/Resubmission/Revision) | May 7, 2026 (AIDS) | June 4, 2026 (New/Renewal/Resubmission/Revision) | September 7, 2026 (AIDS) | October 2, 2026 (New/Renewal/Resubmission/Revision) | January 7, 2027 (AIDS)
Funding Amounts: Up to $1,515,000 in direct costs per year, for a maximum of 3 years (R33 mechanism).
Summary: Supports investigator-initiated, early phase (Phase I) clinical trials for diagnostic or therapeutic interventions in heart, lung, blood, and sleep (HLBS) disorders in adults and children.
Key Information: Applicants must be ready to initiate the clinical trial within the first quarter of the project period; regulatory approvals and trial readiness must be in place by the time of award.
Description
This opportunity from the National Heart, Lung, and Blood Institute (NHLBI) at NIH funds early phase (Phase I) clinical trials for diagnostic and/or therapeutic interventions targeting heart, lung, blood, and sleep (HLBS) disorders in both adults and children. The program is designed for investigator-initiated, single- or multi-site clinical trials that are ready to launch rapidly—within the first quarter of the project period. The R33 mechanism is milestone-driven, emphasizing timely trial initiation, efficient conduct, and completion within three years.
Applicants must have all necessary regulatory approvals (FDA, IRB, DSMB), drug/placebo supplies, and third-party agreements in place by the time of award. If additional time or support is needed for pre-clinical or trial readiness activities, applicants are encouraged to consider the companion R61/R33 phased award (PAR-25-026).
The program aims to accelerate the translation of promising interventions into clinical testing, with a focus on safety, feasibility, and the development of measures for future efficacy trials.
