Alirocumab
As of the edition of 20 October 2026, Alirocumab is an antibody: marketed, first approved in 2015 (US); acts on PCSK9; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Antibody
- Brand name
- Praluent
- First approved
- 24 July 2015 (US)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Sanofi; 3 holders in all
- Registered trials
- 90, 4 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Nervous system; Inherited and neonatal; Lungs and airways; Cancer
US protection
US protection ends in 2028.
The orphan exclusivity ends in 2028 (it covers one use only). The application that gives this date is held by Regeneron.
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 product2 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Alirocumab.
See the 2 companies on route B for this drug, with the facts behind eachRequest 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 | 15 | 4 | 4 | 1 |
| Phase 1 | 15 | 14 | 1 | 0 |
| Phase 2 | 13 | 9 | 2 | 1 |
| Phase 3 | 31 | 27 | 3 | 0 |
| Phase 4 | 16 | 6 | 4 | 2 |
| All trials | 90 |