Inclisiran sodium
As of the edition of 20 October 2026, Inclisiran sodium is an oligonucleotide: marketed, first approved in 2021 (CA); acts on PCSK9; US protection ends in 2034.
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
- 26 July 2021 (CA)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Novartis
- Registered trials
- 16, 0 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Inherited and neonatal; Nervous system
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Novartis.
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 product24 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 24 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PCSK9 | Proprotein convertase subtilisin/kexin type 9 | Q8NBP7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 8 | 4 | 4 | 0 |
| Phase 4 | 4 | 2 | 2 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2017 to now |