Evinacumab

Generic Name
Evinacumab
Brand Names
Evkeeza
Drug Type
Biotech
Chemical Formula
-
CAS Number
1446419-85-7
Unique Ingredient Identifier
T8B2ORP1DW
Background

Evinacumab is a recombinant human IgG4 monoclonal antibody targeted against angiopoietin-like protein 3 (ANGPTL3) and the first drug of its kind. The ANGPTL family of proteins serve a number of physiologic functions - including involvement in the regulation of lipid metabolism - which have made them desirable therapeutic targets in recent years. Loss-of-function mutations in ANGPTL3 have been noted to result in hypolipidemia and subsequent reductions in cardiovascular risk, whereas increases in function appear to be associated with cardiovascular risk, and it was these observations that provided a rationale for the development of a therapy targeted against ANGPTL3.

In February 2021, evinacumab became the first-and-only inhibitor of ANGPTL3 to receive FDA approval after it was granted approval for the adjunctive treatment of homozygous familial hypercholesterolemia (HoFH) under the brand name "Evkeeza". Evinacumab is novel in its mechanism of action compared with other lipid-lowering therapies and therefore provides a unique and synergistic therapeutic option in the treatment of HoFH.

Indication

Evinacumab is indicated, as an adjunct with other lipid-lowering therapies, for the treatment of familial homozygous hypercholesterolemia (HoFH) in patients 5 years of age and older.

Associated Conditions
Homozygous Familial Hypercholesterolaemia (HoFH)
Associated Therapies
-

Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2022-11-10
Last Posted Date
2024-08-27
Lead Sponsor
Daniel Gaudet
Target Recruit Count
10
Registration Number
NCT05611528
Locations
🇨🇦

Ecogene-21, Saguenay, Quebec, Canada

Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2021-04-28
Last Posted Date
2024-05-22
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
21
Registration Number
NCT04863014
Locations
🇺🇸

Saint Louis University, Saint Louis, Missouri, United States

🇨🇦

Clinique des maladies lipidiques de Quebec, Quebec, Canada

🇺🇸

Excel Medical Clinical Trials, LLC, Boca Raton, Florida, United States

and more 36 locations

Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2020-01-18
Last Posted Date
2024-07-16
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
20
Registration Number
NCT04233918
Locations
🇨🇳

Regeneron Research Center, Taipei, Taiwan

🇺🇦

Regeneron Research Site, Kyiv, Ukraine

Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

First Posted Date
2018-03-02
Last Posted Date
2023-02-16
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
52
Registration Number
NCT03452228
Locations
🇬🇧

Regeneron Research Facility, Manchester, United Kingdom

Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2018-01-24
Last Posted Date
2024-04-30
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
116
Registration Number
NCT03409744
Locations
🇺🇦

Clinical Trial Site #2, Kharkiv, Ukraine

🇺🇦

Clinical Trial Site, Kyiv, Ukraine

🇿🇦

Regeneron Study Site, Cape Town, Western Cape, South Africa

and more 2 locations

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

First Posted Date
2018-01-16
Last Posted Date
2021-05-18
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
65
Registration Number
NCT03399786
Locations
🇺🇦

Regeneron Research Site #2, Kyiv, Ukraine

🇺🇦

Regeneron Research Site, Kyiv, Ukraine

🇮🇹

Regeneron Research Site # 2, Napoli, Italy

and more 1 locations

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

First Posted Date
2017-06-05
Last Posted Date
2023-02-10
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
272
Registration Number
NCT03175367
Locations
🇮🇹

Azienda Ospedaliero Universitaria Federico II di Napoli, Napoli, Italy

🇮🇹

Dipartimento di Medicina Traslazionale e di Precisione dell'Università degli Studi di, Rome, Italy

🇺🇸

Office of Dr. John D Homan MD, Newport Beach, California, United States

and more 92 locations

Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-05-10
Last Posted Date
2018-06-25
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
96
Registration Number
NCT03146416
Locations
🇺🇸

WCCT Global, Inc., Cypress, California, United States

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