| Clinical data | |
|---|---|
| Trade names | Rivfloza |
| Other names | DCR-PHXC |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
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 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[edit]
Nedosiran is indicated to lower urinary oxalate levels in people with primary hyperoxaluria type 1.[1]
Society and culture[edit]
Legal status[edit]
The FDA granted the application for nedosiran breakthrough therapy and orphan drug designations.[5]
Names[edit]
Nedosiran is the international nonproprietary name.[6]
References[edit]
- ^ a b c d e "Rivfloza (nedosiran) injection, for subcutaneous use" (PDF). Archived (PDF) from the original on 1 October 2023. Retrieved 1 October 2023.
- ^ "Nedosiran". Dicerna Pharmaceuticals. 17 August 2021. Archived from the original on 26 July 2023. Retrieved 1 October 2023.
- ^ "Rivfloza: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 2 October 2023. Retrieved 1 October 2023.
- ^ "Drug Approval Package: Rivfloza". U.S. Food and Drug Administration (FDA). 18 October 2023. Retrieved 10 January 2024.
- ^ a b 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.
- ^ 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[edit]
- Forbes TA, Brown BD, Lai C (June 2022). "Therapeutic RNA interference: A novel approach to the treatment of primary hyperoxaluria". British Journal of Clinical Pharmacology. 88 (6): 2525–2538. doi:10.1111/bcp.14925. PMC 9291495. PMID 34022071.
- Liu A, Zhao J, Shah M, Migliorati JM, Tawfik SM, Bahal R, et al. (November 2022). "Nedosiran, a Candidate siRNA Drug for the Treatment of Primary Hyperoxaluria: Design, Development, and Clinical Studies". ACS Pharmacology & Translational Science. 5 (11): 1007–1016. doi:10.1021/acsptsci.2c00110. PMC 9667536. PMID 36407951.
External links[edit]
- 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
