Lumasiran
Various Alimentary Tract and Metabolism Products
Sold as OXLUMO
- Drug class
- Various Alimentary Tract and Metabolism Products
- Availability
- Prescription only
- Routes
- Subcutaneous
- Markets covered
- 4
- Products on record
- 4
- FDA reports (12 mo)
- 95
Overview
Lumasiran is an active pharmaceutical ingredient in the Various Alimentary Tract and Metabolism Products group (A16AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | December 1, 2025 |
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| EU European Union | EMA | 1 | October 13, 2025 |
| CA Canada | Health Canada | 1 | July 22, 2025 |
USUnited States· FDA
1 product
Uses
3) ] . OXLUMO is a HAO1 -directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. ( 1 )
How to take
GBUnited Kingdom· MHRA
1 product
Uses
Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
How to take
EUEuropean Union· EMA
1 product
Uses
Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
How to take
CACanada· Health Canada
1 product
Uses
OXLUMO (lumasiran) is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. 1 Pediatrics Pediatrics (< 18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of OXLUMO in pediatric patients has been established.
3 Pharmacokinetics, Special Populations and Conditions, and 14 CLINICAL TRIALS). Limited data is available for patients <2 years of age and weighing <10 kilograms (kg). The efficacy of OXLUMO in PH1 patients <6 years of age was based on a single-arm trial (see 14 CLINICAL TRIALS).
3 Pharmacokinetics, Special Populations and Conditions).
How to take
Sources & citations
- [1]FDA DailyMed · 16985a31-f5e4-45… · revised December 1, 2025 [PDF]
- [2]MHRA (UK) · PLGB505970005 · revised May 15, 2026
- [3]European Medicines Agency · EMEA/H/C/005040 · revised October 13, 2025
- [4]Health Canada (DPD) · 02525755 · revised July 22, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.