[Food and Drug Administration](https://www.fda.gov/)

Forecasted (no due date announced)

$300,000 (single award; cooperative agreement)

Supports research to synthesize and assess the biological activity of individual diastereomers in the siRNA drug LEQVIO (Inclisiran) to inform drug quality and regulatory science.

This is a forecasted opportunity; application details and deadlines are not yet posted.

--- ## Description This funding opportunity, offered by the Food and Drug Administration (FDA), aims to advance regulatory science by supporting research on the stereochemical composition and biological activity of LEQVIO (Inclisiran), an FDA-approved, GalNAc-conjugated siRNA drug. The project will: - Synthesize each diastereomer of LEQVIO in stereochemically pure form. - Assess the biological activity of each pure diastereomer in inhibiting PCSK9, using both in vitro assays and a transgenic mouse model. - Develop analytical methods to identify and characterize the stereochemical structure of each diastereomer. - Evaluate the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. The tools and knowledge developed through this research are expected to be applicable to other GalNAc-conjugated siRNAs and siRNA drugs in general, contributing to the evaluation of generic siRNAs and the quality control of oligonucleotide therapeutics. --- ## Due Dates - This is a **forecasted opportunity**; no application due date has been announced yet. - Researchers should monitor [Grants.gov](https://www.grants.gov/search-results-detail/351130) for updates. --- ## Funding Amount - **Award Ceiling:** $300,000 - **Award Floor:** $300,000 - **Number of Awards:** 1 - **Funding Instrument:** Cooperative Agreement --- ## Eligibility Eligible applicants include: - State, county, city, or township governments - Special district governments - Independent school districts - Public and state-controlled institutions of higher education - Private institutions of higher education - Native American tribal governments (federally recognized and other) - Public housing authorities/Indian housing authorities - Nonprofits with or without 501(c)(3) status (excluding higher education institutions) - For-profit organizations (including small businesses) - Others, as specified in the opportunity - Unrestricted (open to any type of entity listed above) **Additional notes:** - Applicant organizations may submit more than one application if each is scientifically distinct. - Duplicate or highly overlapping applications will not be accepted for review at the same time. --- ## Application Process - As this is a forecasted opportunity, application instructions and deadlines are not yet available. - Interested applicants should regularly check [Grants.gov](https://www.grants.gov/search-results-detail/351130) for the official posting and application package. - Prepare to demonstrate scientific distinction if submitting multiple applications. --- ## Additional Information - No cost sharing or matching is required. - Clinical trials are **not** allowed under this opportunity. - The research is expected to have broad impact on regulatory science, especially for siRNA drug evaluation and quality control. --- ## External Links - [FDA Home Page](https://www.fda.gov/) - [Grant Opportunity on Grants.gov](https://www.grants.gov/search-results-detail/351130) - [FDA Contact Page](https://www.fda.gov/about-fda/contact-fda) --- ## Contact Information | Name | Role | Email | Phone | |--------------|---------|-----------------------------------------|-----------------| | Terrin Brown | Grantor | [terrin.brown@fda.hhs.gov](mailto:terrin.brown@fda.hhs.gov) | (240) 402-7610 | | FDA General | | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888) 463-6332 |

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

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