NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Nov 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Mechanism of Action
(GO) enzyme by targeting the hydroxyacid oxidase 1 ( HAO1 ) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. As the GO enzyme is upstream of the deficient alanine:…
Clinical Trials (5)
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
Started Apr 2024
50 enrolled
HaemodialysisChronic Kidney Disease Requiring Chronic DialysisCardiovascular Disease+2 more
A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
Started Jan 2022
2 enrolled
Recurrent Calcium Oxalate Kidney Stone DiseaseElevated Urinary Oxalate Levels
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
Started Jan 2020
21 enrolled
Primary Hyperoxaluria Type 1Primary Hyperoxaluria
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
Started Apr 2019
18 enrolled
Primary HyperoxaluriaPrimary Hyperoxaluria Type 1 (PH1)
A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1
Started Nov 2018
39 enrolled
Primary Hyperoxaluria Type 1 (PH1)
Loss of Exclusivity
LOE Date
Nov 20, 2038
154 months away
Patent Expiry
Nov 20, 2038
Exclusivity Expiry
Oct 6, 2029