Volanesorsen
As of the edition of 20 October 2026, Volanesorsen is an oligonucleotide: marketed, first approved in 2019 (EU); acts on APOC3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Oligonucleotide
- Brand name
- Waylivra
- First approved
- 3 May 2019 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- PTC FARMACEUTICA DO BRASIL LTDA.; 2 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Nutrition and metabolism; Inherited and neonatal; Skin and connective tissue; Heart and blood vessels
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| APOC3 | Apolipoprotein C-III | P02656 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 4 | 3 | 0 | 1 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Akcea Therapeutics | Applicant and Lead sponsor of trials | 2014 to now |