Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed

The Food and Drug Administration (FDA) is seeking applications for a research project to evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved siRNA drug. The project aims to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo chemically controlled synthesis and biological activity assessment. The proposed studies will focus on synthesis, biological activity assessment, analytical method development, and pharmacological activity assessment. • The project will contribute to the sameness evaluation of generic siRNAs and the quality control of oligonucleotide drugs. • The research will be funded through a cooperative agreement with an award ceiling of $300,000. • Eligible applicants include public and state-controlled institutions of higher education, special district governments, and other organizations. • The application should be scientifically distinct, and the FDA will not accept duplicate or highly overlapping applications.