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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)

US · MD · Bethesda National Institutes of Health (NIH / NHLBI) grant open #RFA-HL-26-017
Response due Dec 23, 2027 · 00:00 UTC

Summary

This NIH/NHLBI funding opportunity (RFA-HL-26-017) solicits R61/R33 phased research applications focused on early-stage therapeutic product development. The R61 phase targets target identification and validation, while the R33 phase focuses on preliminary product or lead series identification for small molecules, biologics, and combination products. Clinical trials are explicitly not allowed under this mechanism. The opportunity is posted on Grants.gov and remains open for applications through late December 2027.

What they want

Applicants must conduct two-phase research: (1) R61 Phase — Target Identification and Validation: identify and validate biological targets relevant to disease areas within NHLBI's mission; (2) R33 Phase — Preliminary Product/Lead Series Identification: identify and characterize preliminary therapeutic product candidates or lead series for small molecules, biologics, or combination products. Clinical trials are not permitted under either phase. Work falls under the NIH Catalyze initiative, which supports early translational research toward product definition.
Deliverables
  • Validated biological target(s) (R61 phase)
  • Preliminary product candidate or lead series identification (R33 phase)
  • Research progress reports per NIH requirements
Technical requirements
  • Two-phase R61/R33 phased innovation award structure required
  • R61 phase must address target identification and validation
  • R33 phase must address preliminary product or lead series identification
  • Scope limited to small molecules, biologics, or combination products
  • Clinical trials not allowed under this funding opportunity

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

  • Rolling/multi-year open window (11/2024–12/2027) is standard for NIH RFAs but warrants monitoring for amendment or closure
  • No dollar amounts disclosed — award size and number of awards not stated in source text
  • Highly specialized scope (target ID/validation + lead series) may favor well-resourced academic or industry research groups with existing target data

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Catalyze: Product Definition for Small Mol…
Due Dec 23
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