EMA · European Union
alirocumab — EMA regulatory status
alirocumab (PRALUENT) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- PRALUENT
- Originator
- Regeneron UK Limited
- Mechanism
- Subtilisin/kexin type 9 inhibitor
- Target
- Proprotein convertase subtilisin/kexin type 9
- Structured fields
- 8
Sponsor / originator context: Regeneron UK Limited. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Subtilisin/kexin type 9 inhibitor. Target: Proprotein convertase subtilisin/kexin type 9. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 28 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Alirocumab | Phase 3 | Regeneron UK | NCT03067844 |
| Alirocumab | Phase 3 | Sanofi Pasteur MSD | NCT02715726 |
| Alirocumab | Phase 3 | Regeneron UK | NCT01617655, NCT02585778 |
| Alirocumab | Phase 3 | Regeneron UK | NCT01266876, NCT01288443 |
| Alirocumab | Phase 3 | First People's Hospital | NCT06080256 |
| Alirocumab | Phase 3 | Regeneron UK | NCT03344692 |
| Alirocumab | Phase 3 | Regeneron UK | NCT03156621 |
| Alirocumab | Phase 3 | Regeneron UK | NCT01663402 |
| Alirocumab | Phase 3 | Sanofi Pasteur MSD | NCT01663402 |
| Alirocumab 150 MG/ML [Praluent] | Phase 3 | Regeneron UK | NCT03480568 |
| Alirocumab SAR236553 | Phase 3 | Regeneron UK | NCT03415178 |
| Placebo (for alirocumab) | Phase 3 | Regeneron UK | NCT01507831, NCT01644175 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12419963 | Diels-Alder conjugation methods | US |
| 12421512 | CRISPR/Cas screening platform to identify genetic modifiers of tau seeding or aggregation | US |
| 12396444 | Mouse comprising a humanized TRKB locus | US |
| 12396952 | Tuning of release kinetics in hydrogels | US |
| 12391734 | PD-1 homing endonuclease variants, compositions, and methods of use | US |
| 12391920 | Models of tauopathy | US |
| 12377159 | Steroids and protein-conjugates thereof | US |
| 12370257 | Materials and methods of treating MHC-I-opathy risk haplotypes | US |
| 12365711 | TGFβ signal convertor | US |
| 12350374 | Fabrication of protein-encapsulating microgels | US |
| 12338199 | Bis-octahydrophenanthrene carboxamides and protein conjugates thereof | US |
| 12325752 | Immunoglobulin proteins that bind to NPR1 agonists | US |
Related hubs
FAQ
What is the EMA approval status of alirocumab?
alirocumab currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get alirocumab regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to alirocumab?
This spoke lists 28 published programs associated with alirocumab in our pipeline index.