Wednesday, July 8, 2026

Drug profile · INN

alirocumab

alirocumab (PRALUENT) is a subtilisin/kexin type 9 inhibitor. Associated with Regeneron UK Limited. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved NMPA: clinical trials Cardiovascular system (C10) C10AX14
US status approved
Patents linked 20
Pipeline programs 28
News articles 0
Drug details — alirocumab
US status
approved
Class
Cardiovascular system (C10)
Route
INJECTION
Patents
20
Programs
28
Data quality
0.89

Quick answer

alirocumab (PRALUENT) is a subtilisin/kexin type 9 inhibitor. Associated with Regeneron UK Limited. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN alirocumab
Brand PRALUENT
Mechanism Subtilisin/kexin type 9 inhibitor
Target Proprotein convertase subtilisin/kexin type 9
Therapeutic class Cardiovascular system (C10)
Route INJECTION
Formulation INJECTABLE
ATC code C10AX14

Mechanism of action

Subtilisin/kexin type 9 inhibitor

Primary target: Proprotein convertase subtilisin/kexin type 9

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. Alirocumab Phase 3 · Regeneron UK · Hypercholesterolaemia
  2. Alirocumab Phase 3 · Regeneron UK · Hypercholesterolemia
  3. Alirocumab Phase 3 · Regeneron UK · Atherosclerotic Cardiovascular Disease
  4. Alirocumab Phase 3 · Sanofi Pasteur MSD · Atherosclerotic Cardiovascular Disease
  5. Alirocumab Phase 3 · Sanofi Pasteur MSD · Hypercholesterolemia
  6. Alirocumab Phase 3 · Regeneron UK · Coronary Vessel
  7. Alirocumab Phase 3 · Regeneron UK · Homozygous Familial Hypercholesterolemia
  8. Alirocumab Phase 3 · Regeneron UK · Type2 Diabetes

Related & competitor drugs

  1. aliskiren Cardiovascular system (C09)
  2. azilsartan medoxomil Cardiovascular system (C09)
  3. bempedoic acid Cardiovascular system (C10)
  4. bosentan Cardiovascular system (C02)
  5. dofetilide Cardiovascular system (C01)
  6. dopamine hydrochloride Cardiovascular system (C01)
  1. US 12419963

    Diels-Alder conjugation methods

    Expires Mon Sep 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12421512

    CRISPR/Cas screening platform to identify genetic modifiers of tau seeding or aggregation

    Expires Mon Sep 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12396444

    Mouse comprising a humanized TRKB locus

    Expires Mon Aug 21 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12396952

    Tuning of release kinetics in hydrogels

    Expires Mon Aug 21 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12391920

    Models of tauopathy

    Expires Mon Aug 14 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 12391734

    PD-1 homing endonuclease variants, compositions, and methods of use

    Expires Mon Aug 14 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 12377159

    Steroids and protein-conjugates thereof

    Expires Mon Jul 31 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 12370257

    Materials and methods of treating MHC-I-opathy risk haplotypes

    Expires Mon Jul 24 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 12365711

    TGFβ signal convertor

    Expires Mon Jul 17 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 12350374

    Fabrication of protein-encapsulating microgels

    Expires Mon Jul 03 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 12338199

    Bis-octahydrophenanthrene carboxamides and protein conjugates thereof

    Expires Mon Jun 19 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 12325752

    Immunoglobulin proteins that bind to NPR1 agonists

    Expires Mon Jun 05 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 12319724

    IL2 agonists and methods of use thereof

    Expires Mon May 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 12297465

    CBLB endonuclease variants, compositions, and methods of use

    Expires Mon May 08 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 12297279

    Compositions and methods for treating pain in subjects with rheumatoid arthritis

    Expires Mon May 08 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 12291560

    Dimerizing agent regulated immunoreceptor complexes

    Expires Mon May 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 12291559

    Compositions and methods for treating cancer

    Expires Mon May 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 12274747

    Compositions and methods for treating cytokine release syndrome

    Expires Mon Apr 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 12264343

    TCRa homing endonuclease variants

    Expires Mon Mar 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 12258627

    Kelch domain containing 7B (KLHDC7B) variants and uses thereof

    Expires Mon Mar 20 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is alirocumab?

alirocumab (PRALUENT) is a subtilisin/kexin type 9 inhibitor. Associated with Regeneron UK Limited. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for alirocumab?

PRALUENT is a marketed brand name for alirocumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of alirocumab?

alirocumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.