evinacumab

Trade name: EVKEEZA

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Feb 11, 2021

Evinacumab, sold under the brand name Evkeeza, is a monoclonal antibody medication for the treatment of homozygous familial hypercholesterolemia (HoFH). — Wikipedia

Clinical trial activity

13 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
3
Phase 2
8
Phase 3
3
Phase 4
1

Earliest trial started Dec 1, 2012 (NCT01749878)

Timeline

2010s

  1. Jan 1, 2012

    Regeneron — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Regeneron — Earliest Phase 2 Sponsor(trial)

  3. Feb 8, 2016

    Orphan Drug Designation

  4. Jan 1, 2018

    Regeneron — Earliest Phase 3 Sponsor(trial)

2020s

  1. Feb 11, 2021

    Regeneron — Earliest FDA Approval

  2. Feb 11, 2021

    Regeneron — Marketing Organization

  3. Feb 11, 2021

    Regeneron — NDA Secondary Org

  4. Feb 11, 2021

    Regeneron — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughFeb 11, 2021

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • evinacumab
  • evinacumab
  • regn1500
  • regn-1500

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07271186Phase 2Dec 9, 2025Regeneron
NCT05611528Phase 4Dec 31, 2022Ecogene 21, Ultragenyx Inc.
NCT04863014Phase 2Jul 12, 2021Regeneron
NCT04233918Phase 3Jun 5, 2020Regeneron
NCT03452228Phase 2Jun 7, 2018Regeneron
NCT03409744Phase 3Mar 13, 2018Regeneron
NCT03399786Phase 3Jan 18, 2018Regeneron
NCT03175367Phase 2Aug 28, 2017Regeneron
NCT03146416Phase 1May 1, 2017Regeneron
NCT02265952Phase 2Oct 1, 2014Regeneron
NCT02107872Phase 1Apr 1, 2014Regeneron
NCT01749878Phase 1Dec 1, 2012Regeneron
NCT06500598N/ARegeneron
Showing 13 of 13 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RegeneronFor profit121242012
Ecogene 21Academic/Hospital1112022
Ultragenyx Inc.For profit1012022
3 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
RegeneronFor profitMKTGFeb 11, 2021
RegeneronFor profitNDA2Feb 11, 2021
RegeneronFor profitNDAFeb 11, 2021