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NIH Phase 1 Exploratory/Developmental Grant (R61)

Single-Site Investigator-Initiated Clinical Trials

Funds a single-site clinical trial in heart, lung or blood disease, run through two milestone-gated phases by one team.

NHLBI wants investigator-led clinical trials that answer real questions in heart, lung, blood and sleep disease — and this is the version built for a single site running the whole thing itself.

What qualifies is broad by design: efficacy trials, comparative effectiveness trials, pragmatic trials, and dissemination and implementation science trials, including ones testing prevention strategies alo

Single-site investigator-initiated clinical trials relevant to NHLBI's research mission — efficacy, comparative effectiveness, pragmatic, and dissemination and implementation science trials, including therapeutic, behavioral and prevention-strategy studies — run as a bi-phasic, milestone-driven award. A clinical trial is required.

CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.Multiple per year
Next deadlineiThe next date applications are due. Rolling means you can apply any time.2 Nov 2028
Decision timeiTypical time from the deadline to the funder's decision.26 weeks
Project durationiHow long the funded work is expected to run.
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Grant
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.
Funding pooliThe total budget available across all awards in this round.

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Last verified: 25 Aug 2026Funder reference: PAR-27-011Source: www.grants.gov