Chemistry:Nedosiran
From HandWiki
Short description: Medication
| Clinical data | |
|---|---|
| Trade names | Rivfloza |
| Other names | DCR-PHXC |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
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| DrugBank | |
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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
Nedosiran is indicated to lower urinary oxalate levels in people with primary hyperoxaluria type 1.[1]
Society and culture
Legal status
The FDA granted the application for nedosiran breakthrough therapy and orphan drug designations.[5]
Names
Nedosiran is the international nonproprietary name.[6]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "Rivfloza (nedosiran) injection, for subcutaneous use". https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215842s000lbl.pdf.
- ↑ "Nedosiran". 17 August 2021. https://dicerna.com/pipeline/nedosiran/.
- ↑ "Rivfloza: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215842.
- ↑ "Drug Approval Package: Rivfloza". 18 October 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215842Orig1s000TOC.cfm.
- ↑ 5.0 5.1 (PDF) New Drug Therapy Approvals 2023 (Report). January 2024. https://www.fda.gov/media/175253/download. Retrieved 9 January 2024.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information 35 (1). 2021.
Further reading
- "Therapeutic RNA interference: A novel approach to the treatment of primary hyperoxaluria". British Journal of Clinical Pharmacology 88 (6): 2525–2538. June 2022. doi:10.1111/bcp.14925. PMID 34022071.
- "Nedosiran, a Candidate siRNA Drug for the Treatment of Primary Hyperoxaluria: Design, Development, and Clinical Studies". ACS Pharmacology & Translational Science 5 (11): 1007–1016. November 2022. doi:10.1021/acsptsci.2c00110. PMID 36407951.
External links
- 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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