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: February 3, 2027 (Applications, 5:00 p.m. local time)
Funding Amounts: R61: up to $250,000 direct costs/year for 2 years; R33: up to $1,515,000 direct costs/year for 3 years; 5 years combined
Summary: Supports investigator-initiated early-phase clinical trials of therapeutics and diagnostics for heart, lung, blood, and sleep disorders.
Key Information: Animal studies, Phase II/III trials, observational studies, and mechanistic or Basic Experimental Studies in Humans are excluded.
Description
The National Heart, Lung, and Blood Institute (NHLBI) supports investigator-initiated early-phase clinical trials of diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. Interventions may include drugs, devices, biologics, cells, and cell products. Single-site and multisite trials are supported, including bridging studies that extend existing clinical data to a new population.
The milestone-driven R61/R33 award combines preparatory work with Phase I trial execution. The R61 phase supports final product-development and trial-startup activities, including formulation, stability and shipping studies, regulatory submissions, protocol development, and potentially Phase 0 trials. The R33 phase primarily assesses product safety and may examine feasibility, acceptability, dose-response, pharmacokinetics, and measures for future efficacy trials. The goal is to accelerate translation of new interventions addressing unmet medical needs.
