Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products – Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 – Clinical Trial Not Allow
Can you apply?
This grant is for researchers and organizations seeking funding to advance early-stage drug discovery and product development for small molecules, biologics, and combination products. Eligible applicants include institutions with research capabilities in medicinal chemistry, pharmacology, and pharmaceutical development—typically academic medical centers, research institutes, and biopharmaceutical companies with PhDs or equivalent expertise. The program specifically excludes clinical trials, focusing instead on preclinical validation, lead series identification, and combination product prototype development. Funding supports the transition from target identification to preliminary lead identification and early formulation work, helping de-risk small molecule and biologic candidates before larger clinical development investments. The R33 mechanism is part of the SBIR/STTR track, so small businesses and small research organizations are especially welcome, though larger institutions may also be eligible depending on institutional policies.
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 support needed 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
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) Application for Federal Assistance
- Project Narrative (typically 15 pages) describing unmet need, lead series rationale, and prototype development plan
- Detailed Budget and Budget Justification (for the full project period)
- Biographical Sketches (NIH format) for all key personnel
- Resources and Environment documentation
- Letters of Support from collaborators or partnering organizations (if applicable)
- Preliminary Data section (NIH format) demonstrating feasibility of lead identification and early characterization
- Quality Overall Summary (2 pages)
- If SBIR/STTR eligible: commercialization plan or pathway documentation
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.855 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$438,527,853
-
$246,626,852
-
$204,359,786
-
$201,437,825
-
$200,221,259
-
$185,816,804
-
$180,737,624
-
$136,265,880
-
$116,817,868
-
$99,478,296
Top States by Funding
- CA 10 awards $818.8M
- WA 3 awards $684.0M
- MA 6 awards $602.8M
- NC 3 awards $446.4M
- NY 7 awards $375.8M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.855). How funding has trended year over year.
| 2024 | $4,073,812,529 | |
| 2025 | $4,378,235,639 | |
| 2026 est. | $4,299,426,996 |
FAQ
Who is eligible to apply for this R33 grant?
Eligible applicants include small businesses (R33-SBIR track), academic institutions, research organizations, and biopharmaceutical companies with the scientific and technical capacity to conduct drug discovery and product development. Your institution must be able to demonstrate expertise in medicinal chemistry, pharmaceutical sciences, or biologics development.
What activities are supported under this grant?
This grant supports preliminary product definition, lead series identification, screening and validation of candidates, formulation development for small molecules and biologics, and prototype development of combination products. Clinical trials are explicitly not allowed; the focus is on preclinical and early translational research.
What is the typical funding range and project duration?
R33 awards for this program typically range from $250,000 to $2 million, with project periods generally spanning 2-3 years. Exact amounts depend on scientific scope and institutional capacity.
When are the application deadlines?
The next deadline is December 23, 2027. Applications open on November 22, 2024. Check the NIH grants portal for any additional submission windows or rolling deadlines.
How competitive is this grant and what makes applications stand out?
This is a moderately to highly competitive program. Strong applications include clear unmet medical need, rigorous preclinical data supporting lead selection, realistic timelines, experienced research teams, and a pathway toward future clinical development or commercial viability.
💡 Tips for applicants
- Ground your lead series selection in robust pharmacology and chemistry data. Reviewers expect clear rationale for why your chosen candidates are superior to alternatives and likely to succeed in later development.
- Develop a realistic prototype or formulation plan. Show that you understand manufacturing, stability, and regulatory pathways even though clinical testing is not part of this grant.
- Build strong partnerships with chemistry and pharmaceutical development experts. If your team lacks industry experience, consider co-investigators from biotech or pharma who understand product development workflows.
- Emphasize the unmet medical need clearly. Explain why current therapies or candidates are inadequate and why your approach addresses a real gap in treatment options.
- Budget conservatively but realistically for analytical chemistry, assay development, preliminary toxicology, and formulation studies. Reviewers want to see that you know what these experiments cost and have allocated resources appropriately.
⚠️ Common mistakes
Many applications fail because they treat this as a basic research grant rather than an applied product development award. Reviewers expect evidence that your lead series is grounded in real medicinal chemistry data, competitive landscape analysis, and a credible path toward IND or manufacturing feasibility. Applications also frequently lack clear decision-making criteria for lead selection or present overly ambitious timelines that attempt to compress what should be 3–4 years of work into 2 years. Finally, teams without pharmaceutical development experience sometimes underestimate regulatory and formulation complexity.
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