EVKEEZA (evinacumab-dgnb)
EVKEEZA is indicated for the treatment of Homozygous Familial Hypercholesterolemia.
How EVKEEZA Works
Evinacumab-dgnb is a recombinant human monoclonal antibody that binds to and inhibits ANGPTL3, a protein primarily expressed in the liver that regulates lipid metabolism. By blocking ANGPTL3, the drug rescues the activity of lipoprotein lipase and endothelial lipase, leading to reductions in triglycerides and high-density lipoprotein cholesterol. It reduces LDL-C independently of the low-density lipoprotein receptor by promoting the processing and clearance of very low-density lipoproteins upstream of LDL formation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-02-11
- Patent Cliff
- 2030
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
EVKEEZA Approval History
What EVKEEZA Treats
1 indicationsEVKEEZA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Homozygous Familial Hypercholesterolemia
EVKEEZA Target & Pathway
ProTarget
EVKEEZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07271186 ANCHOR-POC | ALN-ANG3-CKD-2502 | Ph 2 | recruiting | Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease |
| NCT03409744 results posted | R1500-CL-1719 2017-003170-13 | Ph 3 | completed | Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia |
| NCT05611528 | ECO HoFH-2022-01 | Ph 3 | completed | Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia |
| NCT04233918 results posted | R1500-CL-17100 2019-001931-30 | Ph 3 | completed | Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia |
| NCT04863014 results posted | R1500-HTG-20118 2021-000437-13 | Ph 2 | terminated | Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis |
| NCT03452228 results posted | R1500-HTG-1522 2016-003307-62 | Ph 2 | completed | Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis |
| NCT03175367 results posted | R1500-CL-1643 2017-001508-31 | Ph 2 | completed | Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia |
| NCT03399786 results posted | R1500-CL-1629 2017-001388-19 | Ph 3 | completed | Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia |
| NCT03146416 | R1500-CL-1642 | Ph 1 | completed | Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EVKEEZA FDA Label Details
Indications & Usage
FDA Label (PDF)EVKEEZA is indicated for the treatment of Homozygous Familial Hypercholesterolemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment