NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
Funds Phase I clinical trials for diagnostic/therapeutic interventions in heart, lung, blood, and sleep disorders in adults/children, allowing preclinical activities and milestone-driven support.
Funder: National Institutes of Health
Due Dates: June 4, 2025 (Application) | May 5, 2025 (Letter of Intent) | September 7, 2025 (AIDS) | October 2, 2025 (Application) | January 7, 2026 (AIDS) | February 3, 2026 (Application) | June 4, 2026 (Application) | September 7, 2026 (AIDS) | October 2, 2026 (Application) | January 7, 2027 (AIDS)
Funding Amounts: Up to $250,000 direct costs/year (R61, up to 2 years); up to $1,515,000 direct costs/year (R33, up to 3 years); max 5 years total.
Summary: Supports investigator-initiated, Phase I clinical trials for diagnostic or therapeutic interventions in heart, lung, blood, and sleep disorders, including final-stage preclinical activities.
Key Information: Bi-phasic, milestone-driven R61/R33 mechanism; animal studies not allowed; only Phase I trials eligible.
Description
This opportunity from the National Heart, Lung, and Blood Institute (NHLBI) at NIH funds early phase (Phase I) clinical trials for diagnostic and therapeutic interventions targeting heart, lung, blood, and sleep (HLBS) disorders in adults and children. The grant supports both the start-up and implementation of clinical trials, as well as final-stage preclinical activities necessary to launch the trial. The mechanism is bi-phasic (R61/R33), with the R61 phase focused on preparatory work and the R33 phase on trial execution. All activities must be directly related to the proposed clinical trial, and the program is milestone-driven, with clear go/no-go criteria for transition between phases.
