Opportunity Information: Apply for RFA FD 23 012
This funding opportunity (RFA-FD-23-012) is a Food and Drug Administration cooperative agreement (U01) aimed at clarifying how different diastereomers within the approved siRNA medicine LEQVIO (inclisiran) contribute to its overall biological and pharmacological effects. LEQVIO is a GalNAc-conjugated siRNA that lowers PCSK9, which in turn affects LDL cholesterol levels. Because chemically modified oligonucleotides like inclisiran can contain multiple stereochemical variants (diastereomers) arising from chiral phosphorus centers and related stereochemical features, the FDA is seeking a systematic, well-controlled research program that separates and studies these individual variants rather than treating the drug as a single uniform entity.
The core goal is to map out the diastereomeric composition of LEQVIO and determine what each stereochemically distinct version does biologically. The work described is built around four tightly connected tasks. First, the project must synthesize each diastereomer of inclisiran in stereochemically pure form, using stereochemically controlled methods rather than producing mixtures. Second, the project must test each purified diastereomer for its ability to inhibit PCSK9, using both in vitro assays and an in vivo system specified as a transgenic mouse model, so that differences in potency, efficacy, or other activity-related properties can be measured under controlled conditions. Third, the project must create or refine analytical methods capable of identifying and characterizing the stereochemical structure of each diastereomer present in LEQVIO, which implies developing robust approaches for detection, separation, and structural assignment suitable for complex oligonucleotides. Fourth, the project must integrate the synthesis, analytics, and bioactivity data to estimate how much each individual diastereomer contributes to the overall pharmacological activity observed for the marketed drug product, effectively linking composition to function.
A major motivation running through the announcement is regulatory science: the FDA is emphasizing tools and knowledge that improve evaluation of product quality and support "sameness" determinations for future generic siRNA products. By understanding which stereochemical variants matter most for activity, and by establishing practical analytical methods to profile and characterize those variants, the results could strengthen quality control strategies for oligonucleotide therapeutics more broadly. Although the immediate focus is LEQVIO, the solicitation explicitly notes that the methods and approaches should be transferable to other GalNAc-conjugated siRNAs in particular and potentially to siRNAs in general, helping the field deal with stereochemistry-related complexity across similar drugs.
Administratively, this is a discretionary grant mechanism using a cooperative agreement (meaning the FDA expects substantial involvement during the project rather than a fully hands-off grant). Clinical trials are not allowed under this opportunity. The program is listed under CFDA 93.103 and falls within consumer protection, science and technology, and research and development categories. The anticipated award structure is a single award with an approximate maximum (award ceiling) of $1,200,000. Eligible applicants are broad and include many government entities (state, county, city/township, special districts), public and private institutions of higher education, independent school districts, tribal governments and tribal organizations, public housing/Indian housing authorities, nonprofits with and without 501(c)(3) status, for-profit organizations (including entities other than small businesses), small businesses, and additional eligible categories as referenced in the opportunity text. The opportunity was created December 1, 2022, with an original closing date of March 22, 2023, and it is administered by the Department of Health and Human Services, Food and Drug Administration.Apply for RFA FD 23 012
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Dec 01, 2022.
- Applicants must submit their applications by Mar 22, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,200,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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| Evaluation of oral modified release drug tablet to support the approval of additional strengths Apply for RFA FD 23 013 Funding Number: RFA FD 23 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $450,000 |
| Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008 Funding Number: RFA FD 23 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed Apply for RFA FD 23 014 Funding Number: RFA FD 23 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional Apply for RFA FD 23 006 Funding Number: RFA FD 23 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. Apply for RFA FD 23 007 Funding Number: RFA FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $300,000 |
| Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional Apply for RFA FD 23 015 Funding Number: RFA FD 23 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $750,000 |
| Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional Apply for RFA FD 23 024 Funding Number: RFA FD 23 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,000,000 |
| Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028 Funding Number: RFA FD 23 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed Apply for RFA FD 23 029 Funding Number: RFA FD 23 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,500,000 |
| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001 Funding Number: RFA FD 23 001 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017 Funding Number: RFA FD 23 017 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026 Funding Number: RFA FD 23 026 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
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