FDA · United States
lumasiran sodium — FDA regulatory status
lumasiran sodium (OXLUMO) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- OXLUMO
- Originator
- Alnylam Netherlands B.V.
- Mechanism
- Hydroxyacid oxidase 1 mRNA RNAi inhibitor
- Target
- Hydroxyacid oxidase 1 mRNA
- Structured fields
- 8
Sponsor / originator context: Alnylam Netherlands B.V.. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Hydroxyacid oxidase 1 mRNA RNAi inhibitor. Target: Hydroxyacid oxidase 1 mRNA. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 6 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Lumasiran | Phase 3 | Alnylam Netherlands | NCT03905694 |
| Lumasiran | Phase 3 | Alnylam Netherlands | NCT04152200 |
| Lumasiran | Phase 2 | Alnylam Netherlands | NCT06225544 |
| Lumasiran | Phase 2 | Alnylam Netherlands | NCT03350451 |
| Lumasiran | Phase 2 | Alnylam Netherlands | NCT02706886 |
| Lumasiran | Phase 2 | Alnylam Netherlands | NCT05161936 |
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Related hubs
FAQ
What is the FDA approval status of lumasiran sodium?
lumasiran sodium currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get lumasiran sodium regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to lumasiran sodium?
This spoke lists 6 published programs associated with lumasiran sodium in our pipeline index.