CDEK
← All drugs Report issue

evolocumab

Trade name: repatha

mAbapprovedOrphan Drug FDA

Approved

Aug 27, 2015

Evolocumab, sold under the brand name Repatha, is a monoclonal antibody that is an immunotherapy medication for the treatment of hyperlipidemia. — Wikipedia

Clinical trial activity

119 trials · 106 clinical orgs · 1 marketing orgs

Phase 1
8
Phase 2
62
Phase 3
41
Phase 4
40

Earliest trial started Jun 1, 2010 (NCT01133522)

Timeline

2010s

  1. Jan 1, 2010

    Amgen — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2011

    Amgen — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2012

    Amgen — Earliest Phase 3 Sponsor(trial)

  4. Sep 12, 2013

    Orphan Drug Designation

  5. Aug 27, 2015

    Amgen — Earliest FDA Approval

  6. Aug 27, 2015

    Amgen — Marketing Organization

  7. Aug 27, 2015

    Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 27, 2015

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • amg 145
  • amg 145
  • amg-145
  • amg-145
  • amg-145
  • evolocumab
  • evolocumab
  • evolocumab
  • evolocumab
  • evolocumab
  • evolocumab
  • evolocumab
  • evolocumab
  • evolocumab
  • evolocumab
  • repatha
  • repatha
  • repatha
  • repatha
  • repatha
  • repatha sureclick

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07295366Phase 4Nov 18, 2025Xuzhou Medical University
NCT07036991Phase 4Jul 30, 2025Changhai Hospital, Soochow University
NCT06700720Phase 2Dec 16, 2024Beijing Inno Medicine Co., Ltd.
NCT06496243Phase 2Aug 31, 2024NewAmsterdam Pharma
NCT06284564Phase 2Aug 7, 2024Bristol-Myers Squibb, Department of Defense, State of Texas, University of Texas at Houston
NCT05587621N/AApr 1, 2024Friedrich Schiller University, University of Jena
NCT06140095Early Phase 1 (Phase 1)Feb 29, 2024Amgen, County of Stockholm
NCT06081153Early Phase 1 (Phase 1)Nov 1, 2023Amgen, National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania
NCT05976893Phase 4Aug 1, 2023Xinjiang Medical University
NCT06364124N/AJun 1, 2023Capital Medical University
NCT05741086Phase 3Apr 15, 2023Nanjing Medical University
NCT05697185Phase 4Feb 1, 2023Guangxi Medical University
NCT05613426Phase 4Jan 1, 2023Henan Institute of Cardiovascular Epidemiology
NCT05661552Phase 4Dec 1, 2022Daewoong Pharmaceutical Co. LTD., Yonsei University
NCT05641753Phase 4Nov 16, 2022National Heart, Lung, and Blood Institute (NHLBI), New York University
NCT05579418Phase 4Nov 1, 2022Hamad Medical Corporation
NCT05284747Phase 4Oct 26, 2022Amgen, Colorado Prevention Center
NCT05585151Phase 4Oct 12, 2022Huazhong University of Science and Technology
NCT05802108Phase 4Jul 1, 2022Central Hospital, Zibo
NCT05144529Phase 2Jan 31, 2022Duke University
Showing 20 of 119 trials
Page 1 / 6

Organizations

Research & Development (106)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit594052010
Johns Hopkins UniversityAcademic/Hospital3312017
New York UniversityAcademic/Hospital3322020
University of TorontoAcademic/Hospital3112019
Capital Medical UniversityAcademic/Hospital2222021
Duke UniversityAcademic/Hospital2222021
Harvard UniversityAcademic/Hospital2212021
Icahn School of Medicine at Mount SinaiAcademic/Hospital2212019
Imperial College LondonAcademic/Hospital2112019
LIB Therapeutics LLCFor profit2212019
Nanjing Medical UniversityAcademic/Hospital2222019
National Heart, Lung, and Blood Institute (NHLBI)Government2022022
Policlinico CasilinoAcademic/Hospital2212020
Radboud UniversityAcademic/Hospital2122019
University of California, Los AngelesAcademic/Hospital2112020
University of CopenhagenAcademic/Hospital2122016
University of GothenburgAcademic/Hospital2022016
University of HelsinkiAcademic/Hospital2022016
University of LondonAcademic/Hospital2112019
University of Southern CaliforniaAcademic/Hospital2212017
106 organizations
Page 1 / 6

Marketing (2)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGAug 27, 2015
AmgenFor profitNDAAug 27, 2015