Lumasiran
As of the edition of 20 October 2026, Lumasiran is an oligonucleotide: marketed, first approved in 2020 (EU); acts on ASGR1, ASGR2 and HAO1; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Oligonucleotide
- Brand name
- Oxlumo
- First approved
- 19 November 2020 (EU)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- SPECIALTY PHARMA GOIAS LTDA; 3 holders in all
- Registered trials
- 8, 1 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Inherited and neonatal; Nutrition and metabolism; Heart and blood vessels
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Alnylam Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product15 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Lumasiran.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alnylam Pharmaceuticals | Applicant and Lead sponsor of trials | 2020 to now |