This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed to identify a lead compound series toward development of potential therapeutic agents to treat heart, lung, blood, and sleep (HLBS) diseases and disorders. This NOFO is part of a suite of Catalyze innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical program or attract independent development support from other federal or private partners for preclinical optimization and development of therapeutic agents.
This specific Catalyze Product Definition NOFO will provide the early stage translational support needed for the activities required to develop a lead compound series and combination products to treat HLBS diseases and disorders. Following successful completion of the program, it is expected that the lead compound series will be poised to move forward for preclinical testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. For projects that are at an earlier stage (target identification, validation and testing constituent components of a combination product), a companion initiative is available (RFA-HL-26-017). A therapeutic candidate with two or more distinct, individual components should use RFA-HL-26-017 and its companion RFA-HL26-018. Individual components may include a drug, a biologic, a combination product including a cell or genetic therapy component, or an eligible biologic regulated by the FDA's Center for Biologics Evaluation and Research (CBER), or Center for Drug Evaluation and Research (CDER). Through Catalyze, the small molecule and biologics initiatives have companion initiatives that support development of devices, diagnostics and tools (RFA-HL-26-019 and RFA-HL-26-020), and an initiative to support the development of enabling technologies and transformative platforms for HLBS (RFA-HL-26-016). See website for additional information.
Deadlines:
- Letter of Intent: 30 days prior to the application due date
- Application Due Dates: Feb. 11, 2025; June 18, 2025; Oct 21, 2025; Feb 11, 2026; June 18, 2026; Oct 21, 2026; Feb 11, 2027; June 17, 2027; Oct 21, 2027
- AIDS Application Due Dates: April 21, 2025; Aug 21, 2025; Dec 22, 2025; April 21, 2026; Aug 21, 2026; Dec 23, 2026; April 23, 2027; August 23, 2027; Dec 23, 2027
RFA-HL-26-018 Expiration Date: December 24, 2027
Application budgets must not exceed direct costs of $400,000per year. The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the overall proposed project. Annual project budgets should reflect the actual costs anticipated in each year.
Cost Matching Funds: The recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested.