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Forecasted

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

This forecast was posted November 24, 2023 and last updated November 30, 2023. A forecast is an agency’s statement of planned funding rather than an open opportunity, and this one has not moved in over a year. Agencies do not always withdraw plans they have dropped, so confirm it on the official listing at Grants.gov before building plans around it.

View forecast on Grants.gov →Forecasted — not yet open · no update since November 30, 2023

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 FY2025–FY2027, from public federal spending records.

FY2025 obligated
$213M
FY2026 obligated
$215.3M
FY2027 (to date) obligated
$0
Awards in window
849

Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

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

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

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov

Agency contact: Terrin Brown Grantor · [email protected] · (240) 402-7610

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