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NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)

US · US National Institutes of Health (NIH) — National Heart, Lung, and Blood Institute (NHLBI) grant open #PAR-25-026
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 the development and testing of therapeutics and/or diagnostics for Heart, Lung, Blood, and Sleep (HLBS) disorders. This is a phased award mechanism (R61/R33) where the R61 phase supports milestone-driven feasibility or planning activities, and the R33 phase supports the full early phase clinical trial. A clinical trial is required. The opportunity is open from December 2024 through January 2027, suggesting a multi-cohort/multi-cycle submission window.

What they want

Applicants must propose early phase clinical trials (Phase 0, I, or II) for therapeutics and/or diagnostics targeting HLBS disorders. The R61 phase must include defined go/no-go milestones that, if met, allow transition to the R33 phase for conducting the clinical trial itself. Both phases require a clinical trial as defined by NIH. Research must be relevant to the NHLBI mission covering heart, lung, blood, and sleep disorders.
Deliverables
  • R61 phase milestone report and go/no-go decision documentation
  • Early phase clinical trial protocol
  • Clinical trial data and results from R33 phase
  • Progress reports per NIH grant requirements
Technical requirements
  • Must propose an early phase clinical trial (NIH definition) for HLBS disorders
  • R61 phase must include defined, measurable go/no-go milestones
  • Successful completion of R61 milestones required to transition to R33 phase
  • Clinical trial is required for both phases (R61 and R33)
  • Research must be within the NHLBI mission scope (heart, lung, blood, and sleep disorders)
Key personnel
  • Principal Investigator (PI) with clinical trial expertise
  • Clinical investigators qualified to conduct human subjects research

How they evaluate

  • Scientific and technical merit (as evaluated by NIH peer review)
  • Significance and innovation of proposed therapeutics/diagnostics
  • Approach and feasibility of proposed clinical trial design
  • Qualifications of investigators and team
  • Clarity and appropriateness of R61 milestones
Submission: Grants.gov federal grants portal (electronic submission)

Eligibility & certifications

SAM.gov / Grants.gov registrationIRB (Institutional Review Board) approval for human subjects researchNIH human subjects research training complianceInstitutional assurance for clinical trials (e.g., FWA)

Risks & flags

  • No red flags identified — this is a standard NIH program announcement open to the broad research community with a multi-year submission window
  • Long open window (Dec 2024 – Jan 2027) with multiple submission cycles is typical for NIH PARs and does not suggest wiring for a single applicant

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
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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