Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
Federal funding opportunity FOR-FD-24-007 from Food and Drug Administration.
View forecast on Grants.gov →Forecasted — not yet open
- Posted
- November 24, 2023
- Closes
- See announcement
- Award ceiling
- $300,000
- Award floor
- $300,000
- Expected awards
- 1
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
Program funding history
Awards made under Assistance Listing 93.103 across FY2024–FY2026, from public federal spending records.
- FY2024 obligated
- $250.8M
- FY2025 obligated
- $213M
- FY2026 (to date) obligated
- $15M
- Awards in window
- 911
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, The Medical Device Innovation Consortium, Duke University
Source: USAspending.gov · refreshed July 2026
Synopsis
The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo chemically controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereo chemically pure form; 2) assessment of the biological activity of each stereo chemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs.
Who can apply
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Native American tribal organizations (other than Federally recognized tribal governments)
- Independent school districts
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- City or township governments
- County governments
- Special district governments
- Native American tribal governments (Federally recognized)
- Small businesses
- Public housing authorities/Indian housing authorities
- State governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Public and State controlled institutions of higher education
- For profit organizations other than small businesses
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
How to apply
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