Nedosiran

Nedosiran, sold under the brand name Rivfloza, is a medication used for the treatment of primary hyperoxaluria.[1] It is an LDHA-directed small interfering RNA developed by Dicerna Pharmaceuticals.[1][2]

Nedosiran
Clinical data
Trade namesRivfloza
Other namesDCR-PHXC
AHFS/Drugs.comMonograph
License data
Routes of
administration		Subcutaneous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII

Nedosiran was approved for medical use in the United States in September 2023.[1][3][4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]

Medical uses

Nedosiran is indicated to lower urinary oxalate levels in people with primary hyperoxaluria type 1.[1]

Society and culture

The FDA granted the application for nedosiran breakthrough therapy and orphan drug designations.[5]

Names

Nedosiran is the international nonproprietary name.[6]

References
  1. "Rivfloza (nedosiran) injection, for subcutaneous use" (PDF). Archived (PDF) from the original on 1 October 2023. Retrieved 1 October 2023.
  2. "Nedosiran". Dicerna Pharmaceuticals. 17 August 2021. Archived from the original on 26 July 2023. Retrieved 1 October 2023.
  3. "Rivfloza: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 2 October 2023. Retrieved 1 October 2023.
  4. "Drug Approval Package: Rivfloza". U.S. Food and Drug Administration (FDA). 18 October 2023. Retrieved 10 January 2024.
  5. New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
  6. World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.

Further reading
  • Clinical trial number NCT03847909 for "A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 (PHYOX2)" at ClinicalTrials.gov
  • Clinical trial number NCT04042402 for "Long Term Extension Study in Patients With Primary Hyperoxaluria (PHYOX3)" at ClinicalTrials.gov


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