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Drug

Evinacumab

Approved medicine
ClassAngiopoietin-related protein 3 inhibitorResearchOngoing clinical research

Also known as Evkeeza.

RxNorm2478335ChEMBLCHEMBL3545191ATCC10AX17UNIIT8B2ORP1DW
1
Active clinical trials
Angiopoietin-related protein 3
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of ANGPTL3 Inhibition With Either Small-Interfering RNA Alone or in Combination With an ANGPTL3 Antibody in Participants With Diabetic Kidney Disease

Clinical trial2026-07-16Results expected Q3 2027 · ClinicalTrials.gov

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Clinical trial2025-04-08Results posted · ClinicalTrials.gov

Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia in a Real Life Setting in Canada

Clinical trial2025-03-18Completed · ClinicalTrials.gov

A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

Clinical trial2024-07-16Results posted · ClinicalTrials.gov

A Phase 2, Randomized, Placebo-Controlled Study of Safety and Efficacy, Following Repeat-Dose Administration of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

Clinical trial2023-02-16Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

Clinical trial2023-02-15Terminated · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

Clinical trial2023-02-10Results posted · ClinicalTrials.gov

Approval: Evkeeza (EMA)

Regulatory2021-06-17EMA

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Clinical trial2021-05-18Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Evinacumab in Healthy Japanese and Caucasian Subjects

Clinical trial2018-06-14Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Evinacumab
Aliases & brands
Evkeeza
RxNorm CUI
2478335
ChEMBL ID
CHEMBL3545191
ATC codes
C10AX17
UNII
T8B2ORP1DW
Primary mechanism
Angiopoietin-related protein 3 inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Angiopoietin-related protein 3
ANGPTL3 · Q9Y5C1
INHIBITORAngiopoietin-related protein 3 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-06-17
Latest approval
2021-06-17
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-06-17Approval
Approval: Evkeeza (EMA)
Indication: Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12… Show full indication

Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

9 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
9
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
1
Recruiting
4
Late-stage (III+)
7
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 9
Phase 11Phase 24Phase 34

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia in a Real Life Setting in Canada

CompletedPH IIIDaniel Gaudetn=102025

A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

CompletedPH IIIRegeneron Pharmaceuticalsn=202023

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

CompletedPH IIIRegeneron Pharmaceuticalsn=1162023

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

CompletedPH IIIRegeneron Pharmaceuticalsn=652020

Recent completions

Trials that read out recently, adding to the completed evidence base.

Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia in a Real Life Setting in Canada

CompletedPH IIIDaniel Gaudetn=102025

A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

CompletedPH IIIRegeneron Pharmaceuticalsn=202023

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

CompletedPH IIIRegeneron Pharmaceuticalsn=1162023

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

CompletedPH IIRegeneron Pharmaceuticalsn=2722020

A Phase 2, Randomized, Placebo-Controlled Study of Safety and Efficacy, Following Repeat-Dose Administration of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

CompletedPH IIRegeneron Pharmaceuticalsn=522020

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

CompletedPH IIIRegeneron Pharmaceuticalsn=652020
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.