Funder: National Institutes of Health
Due Dates: June 18, 2025 (New/Renewal/Resubmission/Revision) | August 21, 2025 (AIDS) | October 21, 2025 (New/Renewal/Resubmission/Revision) | December 22, 2025 (AIDS) | Additional cycles through December 2027
Funding Amounts: Up to $400,000 direct costs per year for up to 2 years; minimum 25% non-federal cost match required; ~8 new awards per year
Summary: Supports early-stage translational research to identify and characterize small molecule, biologic, and combination product therapeutic candidates for heart, lung, blood, and sleep (HLBS) disorders.
Key Information: Requires a committed Accelerator Partner and a cost match; clinical trials are not allowed; incomplete applications will not be reviewed.
Description
This opportunity, part of the NHLBI Catalyze Program, funds early-stage translational research to advance small molecules, biologics, and combination products as potential therapies for heart, lung, blood, and sleep (HLBS) diseases and disorders. The program aims to bridge the gap between basic science discoveries and preclinical development, supporting projects that have identified and validated lead compound series and are ready for further characterization and optimization.
The initiative is designed to help projects reach a stage where they can enter the NHLBI Catalyze Preclinical Program or attract independent development support. It is part of a suite of innovation grants, with companion opportunities available for device, diagnostic, and enabling technology development.
Due Dates
- Standard Deadlines:
- June 18, 2025 (New, Renewal, Resubmission, Revision)
- October 21, 2025 (New, Renewal, Resubmission, Revision)
- February 11, 2026; June 18, 2026; October 21, 2026; February 11, 2027; June 17, 2027; October 21, 2027 (and corresponding AIDS deadlines)
- AIDS Deadlines:
- August 21, 2025; December 22, 2025; April 21, 2026; August 21, 2026; December 23, 2026; April 23, 2027; August 23, 2027; December 23, 2027
- Letter of Intent: 30 days prior to application due date
- Expiration: December 24, 2027
All applications are due by 5:00 PM local time of the applicant organization.
Funding Amount
- Direct Costs: Up to $400,000 per year (maximum 2 years)
- Total Project Period: Up to 2 years
- Cost Matching: Minimum 25% non-federal cash match of the federal direct costs is required
- Number of Awards: NHLBI expects to fund up to 8 new awards per year (subject to appropriations and meritorious applications)
- Budget Justification: Must include both federal and non-federal (cost-matching) components
Eligibility
Eligible applicants include:
- Public and private institutions of higher education
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Independent school districts
- Native American tribal governments and organizations
- Public housing authorities/Indian housing authorities
- Faith-based and community-based organizations
- Regional organizations
- U.S. territories and possessions
Restrictions:
- Non-domestic (non-U.S.) entities are not eligible to apply as the primary applicant.
- Non-domestic components of U.S. organizations and foreign components (as defined by NIH) are allowed.
- Applicants must complete all required registrations (SAM, eRA Commons, Grants.gov) prior to submission.
Application Process
- Submission: Applications must be submitted electronically via Grants.gov or the NIH ASSIST system.
- Required Attachments:
- Preliminary Intellectual Property (IP) and regulatory strategies (as a PDF attachment)
- Letter of support from a committed Accelerator Partner (application will not be reviewed without this)
- Letters of support for cost matching from non-federal sources
- Budget: Include support for PI attendance at an NHLBI innovation meeting/workshop each year and appropriate project management support.
- Milestones: Applications must propose specific, measurable, achievable, relevant, and time-bound milestones and a project timeline (e.g., GANTT chart).
- Data Management: All applications must include a Data Management and Sharing Plan.
- Review: Applications are peer-reviewed for scientific merit, feasibility, and alignment with program goals.
Additional Information
Required Project Features
- Accelerator Partner: Applicants must identify and include a letter of support from an Accelerator Partner (commercialization expert or organization) who will provide guidance and mentoring on product development, regulatory strategy, and commercialization.
- Cost Matching: At least 25% of the direct federal costs must be matched with non-federal cash contributions. Matching funds must be documented and cannot come from other federal sources.
- IP and Regulatory Strategy: Applications must include a preliminary plan for intellectual property and regulatory pathway, even if not fully developed.
- Project Management: Each project must designate a team member responsible for project management and milestone tracking.
- Non-Responsive Activities: The following are not supported:
- Target identification and validation (see companion NOFO)
- Assay/probe development for basic research
- Device, diagnostic, or tool development (see companion NOFOs)
- Biomarker development
- IND-enabling studies, GMP manufacturing, or clinical trials
Companion Opportunities
- Device/diagnostic development: RFA-HL-26-019, RFA-HL-26-020
- Enabling technologies: RFA-HL-26-016
- Earlier-stage projects: RFA-HL-26-017
External Links
Contact Information
See Also