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

US · MD · Bethesda National Institutes of Health (NHLBI – National Heart, Lung, and Blood Institute) grant open #PAR-25-025
Response due Jan 07, 2027 · 00:00 UTC

Summary

The National Heart, Lung, and Blood Institute (NHLBI) is soliciting applications for early phase clinical trials focused on therapeutics and/or diagnostics for Heart, Lung, Blood, and Sleep (HLBS) disorders under the R33 mechanism, which requires a clinical trial component. This is a federal grant opportunity (PAR-25-025) posted through Grants.gov targeting researchers proposing to advance promising interventions or diagnostic tools from early development into structured human clinical testing. The opportunity opened in December 2024 and remains open through January 2027, reflecting a multi-cycle funding announcement.

What they want

Applicants must propose and conduct early phase clinical trials (e.g., Phase I or Phase II) evaluating novel therapeutics and/or diagnostics for disorders within the NHLBI mission areas: heart, lung, blood, and sleep (HLBS). The R33 activity code is required, indicating this is a milestone-driven exploratory/developmental research phase. A clinical trial component is mandatory per the funding opportunity announcement (CT Required designation).
Technical requirements
  • Clinical trial must be early phase (Phase I or Phase II equivalent)
  • R33 activity code required
  • Clinical Trial (CT) component is mandatory
  • Research must target HLBS (Heart, Lung, Blood, and Sleep) disorders
  • Must propose therapeutics and/or diagnostics

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

  • No dollar value or award ceiling disclosed, limiting competitive cost benchmarking
  • Highly specialized scope (HLBS early phase clinical trials with mandatory R33 + CT designation) may limit applicant pool to established NIH-connected research institutions

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

NHLBI Early Phase Clinical Trials for Ther…
Due Jan 07
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