Inclisiran
As of the edition of 20 October 2026, Inclisiran is an oligonucleotide: marketed, first approved in 2020 (EU); acts on PCSK9.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Oligonucleotide
- Brand name
- Leqvio
- First approved
- 9 December 2020 (EU)
- Approvals on record
- 5 in 5 regions
- Holder of the most recent approval
- Novartis; 3 holders in all
- Registered trials
- 33, 0 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Inherited and neonatal; Hormones; Nervous system; Pregnancy and women's health
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 |
|---|---|---|
| PCSK9 | Proprotein convertase subtilisin/kexin type 9 | Q8NBP7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 1 | 2 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 3 | 1 | 0 |
| Phase 3 | 14 | 8 | 6 | 0 |
| Phase 4 | 9 | 1 | 8 | 0 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2016 to now |