NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
About
The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.
The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required) is a federal funding opportunity designed to support investigator-initiated Phase I clinical trials for innovative diagnostic and therapeutic interventions targeting heart, lung, blood, and sleep disorders in both adult and pediatric populations. This grant is ideal for researchers and institutions seeking to advance promising preclinical discoveries into human clinical testing. The funding mechanism is bi-phasic and milestone-driven, with the R61 phase supporting essential pre-trial activities such as stability studies, shipping validation, site training, and other critical preparations needed before clinical trial implementation. The R33 phase follows upon successful completion of R61 milestones and funds the actual clinical trial execution. Applicants can propose single or multi-site trials. This opportunity is particularly valuable for institutions committed to developing treatments and diagnostics that address significant unmet medical needs in cardiopulmonary and hematologic diseases. Eligible applicants include HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based and community-based organizations, and other qualified entities. Researchers with innovative early-stage therapeutic or diagnostic concepts should apply to move their discoveries toward clinical validation and patient benefit.
Funding Facts
● Applications openDeadline
January 7, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle—consult official NOFO
Deadline
2027-01-07
Grant Type
federal
Application Cycle
Annual (Next deadline: January 7, 2027)
Best For
Research institutions, HBCUs, minority-serving institutions, and investigators with Phase I clinical trial proposals for heart, lung, blood, and sleep disorder therapeutics and diagnostics
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Govern
Frequently Asked Questions
Who is eligible for NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)?
Eligible applicants include HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, eligible federal agencies, faith-based and community-based organizations, and Indian/Native American tribal governments. For a complete list of eligible applicant types and any specific institutional requirements, consult the official NHLBI funding announcement on grants.nih.gov.
How much funding does NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required) provide?
Specific funding amounts are not listed in the current information available. Award amounts vary depending on the scope and complexity of proposed pre-clinical activities and clinical trial design. For detailed budget information and funding ranges for the current funding cycle, visit the official NHLBI Notice of Funding Opportunity (NOFO) on grants.nih.gov.
How do I apply for NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)?
Applications are submitted through Grants.gov using the NIH application system. You will need an active institutional account and eRA Commons credentials. The application process typically involves preparing a detailed research proposal, budget justification, and supporting documentation specific to early-phase clinical trial requirements. Visit grants.nih.gov and search for the NHLBI NOFO to access the complete application guidelines, required forms, and submission instructions. The next deadline is January 7, 2027.
What can NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required) funding be used for?
R61 phase funding supports clinical trial start-up and implementation activities, including final-stage preclinical work directly related to therapeutic or diagnostic preparation for the trial. Eligible activities include stability studies, shipping validation studies, site training, regulatory preparation, and other pre-trial activities. R33 phase funding, awarded upon successful R61 milestone completion, supports the actual Phase I clinical trial execution. All proposed activities must directly advance the readiness of the therapeutic or diagnostic intervention for human clinical testing.
Last updated: July 5, 2026