Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed)

---

Description

This opportunity, offered by the National Heart, Lung, and Blood Institute (NHLBI) under the NIH Catalyze program, supports early-stage translational research to identify, validate, and characterize potential therapeutic candidates—small molecules, biologics, and combination products—for heart, lung, blood, and sleep (HLBS) diseases and disorders. The program aims to bridge the gap between basic science discoveries and preclinical development, providing resources and expertise to help researchers advance promising therapies toward human testing.

The grant uses a two-phase (R61/R33) mechanism:

• R61 phase: Focuses on target identification, validation, and initial screening of compounds or components.
• R33 phase: Supports lead series identification, further characterization, and preclinical development activities.

The program is part of a suite of Catalyze innovation grants, with companion opportunities for device, diagnostic, and enabling technology development.

---

Due Dates

• Standard (New/Renewal/Resubmission/Revision):

  • June 18, 2025
  • October 21, 2025
  • February 11, 2026
  • June 18, 2026
  • October 21, 2026
  • February 11, 2027
  • June 17, 2027
  • October 21, 2027

• AIDS-related applications:

  • 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 the application due date

All applications are due by 5:00 PM local time of the applicant organization.

---

Funding Amount

• Direct Costs: Up to $400,000 per year for each phase (R61 and R33)
• Project Period: Maximum of 3 years total (up to 2 years for R61, up to 2 years for R33; cannot be awarded in the same fiscal year)
• Cost Matching: R33 phase requires a minimum 0.25:1 non-federal cash match of the federal direct costs requested
• Number of Awards: Up to 8 new awards per year (FY26–FY28), subject to NIH appropriations and meritorious applications

---

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
• Public housing authorities/Indian housing authorities
• Native American tribal governments (federally recognized and other)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions

Note:

• 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.
• Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are encouraged to apply.

---

Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required Registrations: SAM, eRA Commons, Grants.gov (can take 6+ weeks).
• Letter of Intent: Strongly encouraged, due 30 days before the application deadline.
• Application Guide: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
• Key Attachments:
  • "IP and Regulatory Strategies" PDF (required; applications missing this will not be reviewed)
  • Data Management and Sharing Plan
  • Milestone and timeline plan for both R61 and R33 phases
  • Budget justification (including details of cost matching for R33)
• Review: Applications are peer-reviewed for scientific merit, feasibility, innovation, and alignment with program goals.

---

Additional Information

• Clinical Trials: Not allowed under this opportunity.
• Non-Responsive Activities: Applications focused on basic research, device/diagnostic development, biomarker development, IND-enabling studies, GMP manufacturing, or clinical trials will not be reviewed.
• Milestones: Clear, quantifiable milestones for both phases are required; R33 funding is contingent on successful completion of R61 milestones.
• Accelerator Partner: At least one Accelerator Partner (commercialization expert) is required for the R33 phase; evidence of this partnership is needed before transition from R61 to R33.
• Cost Matching: R33 phase requires a non-federal cash match (minimum 0.25:1); in-kind contributions do not count toward this requirement.
• Intellectual Property and Regulatory Planning: Applicants must address IP and regulatory strategies appropriate to the stage of development.
• Companion Opportunities: Related funding opportunities exist for device, diagnostic, and enabling technology development.

---

External Links

• Full Funding Opportunity Announcement (NIH)
• NHLBI Catalyze Program Overview
• NIH SF424 (R&R) Application Guide
• Grants.gov Opportunity Listing
• NIH Data Management and Sharing Policy

---

Contact Information

---