Nedosiran

Nedosiran

Nedosiran

Medication

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]

Quick Facts Clinical data, Trade names ...

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. [1]
    "Rivfloza (nedosiran) injection, for subcutaneous use" (PDF). Archived (PDF) from the original on 1 October 2023. Retrieved 1 October 2023.
  2. [2]
    "Nedosiran". Dicerna Pharmaceuticals. 17 August 2021. Archived from the original on 26 July 2023. Retrieved 1 October 2023.
  3. [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. [4]
    "Drug Approval Package: Rivfloza". U.S. Food and Drug Administration (FDA). 18 October 2023. Retrieved 10 January 2024.
  5. [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. [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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