Catalyze: Product Definition for Small Molecules, Biologics and Combination Products – Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trial
Can you apply?
This grant is for researchers and research organizations conducting early-stage drug development and biomedical research focused on small molecules, biologics, and combination products. Eligible applicants include academic institutions, nonprofit organizations, for-profit companies, and government agencies that can demonstrate scientific and technical merit in target identification, validation, and preliminary product/lead series identification. The program explicitly excludes clinical trials, making it suitable for preclinical and translational research phases. Applicants must have appropriate institutional infrastructure, including research facilities and qualified personnel. The grant operates through the NIH's R61/R33 dual-phase mechanism, allowing for phased funding based on milestone achievement. Research can be conducted across the United States and qualifying U.S. territories. Organizations must be willing to document research progress and comply with NIH reporting requirements and regulatory standards.
This grant is for researchers and research organizations conducting early-stage drug development and biomedical research focused on small molecules, biologics, and combination products. Eligible applicants include academic institutions, nonprofit organizations, for-profit companies, and government agencies that can demonstrate scientific and technical merit in target identification, validation, and preliminary product/lead series identification. The program explicitly excludes clinical trials, making it suitable for preclinical and translational research phases. Applicants must have appropriate institutional infrastructure, including research facilities and qualified personnel. The grant operates through the NIH's R61/R33 dual-phase mechanism, allowing for phased funding based on milestone achievement. Research can be conducted across the United States and qualifying U.S. territories. Organizations must be willing to document research progress and comply with NIH reporting requirements and regulatory standards.
Program description
The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative will provide the early stage translational supportneeded for the activities required to identify and characterize potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This initiative has a companion initiative that supports development of devices and diagnostics and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers and research organizations conducting early-stage drug development and biomedical research focused on small molecules, biologics, and combination products. Eligible applicants include academic institutions, nonprofit organizations, for-profit companies, and government agencies that can demonstrate scientific and technical merit in target identification, validation, and preliminary product/lead series identification. The program explicitly excludes clinical trials, making it suitable for preclinical and translational research phases. Applicants must have appropriate institutional infrastructure, including research facilities and qualified personnel. The grant operates through the NIH's R61/R33 dual-phase mechanism, allowing for phased funding based on milestone achievement. Research can be conducted across the United States and qualifying U.S. territories. Organizations must be willing to document research progress and comply with NIH reporting requirements and regulatory standards.
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) and associated forms (PHS 398 or equivalent)
- Project narrative and specific aims (typically 12-15 pages)
- Detailed budget and budget justification
- Biosketches of key personnel (NIH format)
- Institutional support letters and commitment statements
- Letters of collaboration from industry partners or target companies (if applicable)
- Preliminary data and supporting figures/tables
- Research strategy including background, significance, innovation, and approach
- Vertebrate animals or human subjects documentation (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.838 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$64,183,283
-
$53,344,199
-
$43,989,024
-
$38,428,037
-
$34,243,478
-
$27,859,190
-
$26,861,834
-
$26,624,924
-
$26,063,829
-
$25,153,102
Top States by Funding
- MA 14 awards $246.0M
- CA 15 awards $199.1M
- CO 8 awards $139.0M
- IL 7 awards $107.8M
- NC 4 awards $95.8M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.838). How funding has trended year over year.
| 2024 | $760,925,134 | |
| 2025 | $789,408,855 |
FAQ
What types of organizations can apply for this grant?
Universities, medical schools, nonprofit research institutions, small businesses, large companies, and government agencies are eligible. Applicants must have a fiscal sponsoring institution if needed and demonstrate appropriate research infrastructure.
What is the R61/R33 mechanism and how does it work?
This is a two-phase funding structure. The R61 is the initial exploratory phase (typically 1-2 years) focused on target identification and validation. Successful R61 awardees can then transition to the R33 phase for lead series identification and optimization, with potential for extended funding based on meeting predefined milestones.
Can clinical trials be included in this grant?
No. This grant explicitly prohibits clinical trials. Research must remain in the preclinical, target validation, and early translational stages. Any application including human subjects research involving investigational drug testing will be ineligible.
What are the competitive priorities for this funding cycle?
Typically, NIH prioritizes research addressing unmet medical needs, innovative methodologies for target identification, and clear pathways toward therapeutic development. Strong preliminary data, feasibility of proposed milestones, and a clear drug development strategy increase competitiveness.
What is the typical funding range and timeline?
R61 phase awards typically range from $200,000-$500,000 annually depending on complexity, with R33 phases potentially higher. The deadline shown is fixed for 2027, but specific funding amounts and submission cycles should be verified on grants.nih.gov.
💡 Tips for applicants
- Clearly distinguish your target identification and validation work from clinical development; emphasize mechanistic understanding and early-stage pharmacology rather than therapeutic efficacy in patients
- Use strong preliminary data to support feasibility of R61 milestones; reviewers want confidence that you can achieve proof-of-concept for target engagement within the proposed timeline
- Structure your proposal with explicit, measurable milestones that align with the R61 phase, making the case for progression to R33 contingent on realistic go/no-go criteria
- Address intellectual property and publication strategy early, as NIH reviewers assess whether your approach will generate actionable leads or tool compounds for the broader research community
- Ensure your team has complementary expertise spanning target validation (biochemistry, structural biology, cell biology) and medicinal chemistry/drug design for the lead series phase
⚠️ Common mistakes
Applications often fail because they blur the line between basic research and early drug development, leaving reviewers uncertain about the pathway to actual lead compounds. Another common pitfall is proposing insufficiently rigorous target validation—reviewers expect functional assays, selectivity data, and clear evidence that the target is tractable before moving to lead identification. Finally, weak project management or unrealistic timelines in the R61 phase signal that milestones won't be met, significantly reducing competitiveness.
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