Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you have expertise in siRNA chemistry or diastereomeric analysis, the FDA is funding collaborative research into inclisiran's molecular variants outside of clinical trials.
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What this is
The FDA is soliciting research into the chemical synthesis and biological characterization of diastereomeric forms of inclisiran, a lipid nanoparticle-based siRNA therapeutic approved for PCSK9 inhibition. This U01 grant mechanism is designed for hypothesis-driven research collaborations, though clinical trial work on the drug itself is explicitly excluded. Applicants should have expertise in organic chemistry, pharmaceutical development, or siRNA therapeutics and be prepared to work within FDA regulatory frameworks.
Who can apply
Eligibility criteria are unspecified in the posting; however, U01 mechanisms typically support academic medical centers, research institutions, small biotech firms, and non-profits. Applicants cannot be conducting active clinical trials with inclisiran. Confirm detailed eligibility with the FDA.
Topics: sirna drug development · diastereomer synthesis · inclisiran leqvio · pharmaceutical chemistry · fda funded research · biologics characterization
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.