eculizumab

Trade name: Soliris

mAbapprovedCOVID-19Orphan Drug FDA

Approved

Mar 16, 2007

Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica. In people with paroxysmal nocturnal hemoglobinuria, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Eculizumab was the first medication approved for each of its uses, and its approval was granted based on small trials. It is given by intravenous infusion. It is a humanized monoclonal antibody functioning as a terminal complement inhibitor. It binds to the complement C5 protein and inhibits activation of the complement system, a part of the body's immune system. This binding prevents the breakdown of red blood cells in the bloodstream in people with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. — Wikipedia

Clinical trial activity

104 trials · 66 clinical orgs · 3 marketing orgs

Phase 1
13
Phase 2
83
Phase 3
44
Phase 4
6

Earliest trial started Apr 1, 2000 (NCT00005571)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Alexion — Earliest Phase 3 Sponsor(trial)

  3. Aug 20, 2003

    Orphan Drug Designation

  4. Mar 16, 2007

    Alexion — Earliest FDA Approval

  5. Mar 16, 2007

    Alexion — Marketing Organization

  6. Mar 16, 2007

    Alexion — NDA Organization

  7. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2020s

  1. May 28, 2024

    Amgen — Marketing Organization

  2. Jul 19, 2024

    Samsung — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedMar 16, 2007

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • 5g1.1
  • 5g1.1
  • 5g1.1-sc
  • eculizumab
  • eculizumab
  • eculizumab
  • eculizumab
  • eculizumab
  • eculizumab
  • eculizumab
  • eculizumab
  • eculizumab
  • h5g1.1
  • h5g1.1
  • h5g1.1
  • h5g1.1-sc
  • h5g1.1 scfv
  • h5g1.1-scfv
  • h5g1.1 scfv (cdr)
  • h5g1.1vhc+h5g1.1vlc
  • h5g1.1vhc+h5g1.1vlc
  • pexelizumab
  • pexelizumab
  • pexelizumab
  • pexelizumab
  • soliris
  • soliris
  • soliris
  • soliris
  • soliris

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07177859Phase 3Nov 30, 2025Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
NCT07010302Phase 4Nov 30, 2025Harvard University, Humboldt University, Patient-Centered Outcomes Research Institute
NCT07184840Phase 2Sep 9, 2025Tianjin Medical University
NCT06799546Phase 3Feb 20, 2025Haisco Pharmaceutical
NCT06764160Phase 3Jan 6, 2025Alexion
NCT06724809Phase 3Dec 24, 2024Alexion, AstraZeneca, Fudan University
NCT06673394Phase 2Dec 1, 2024Tianjin Medical University
NCT06593938Phase 3Sep 30, 2024Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT06932744Phase 3Aug 30, 2024Wuhan Createrna Science and Technology Co., Ltd
NCT06513338Phase 2Aug 1, 2024Peking University
NCT06453135Phase 1/Phase 2 (Phase 2)Jul 31, 2024Sichuan University
NCT05726916Phase 3Oct 15, 2023Assistance Publique - Hôpitaux de Paris
NCT05876351Phase 3Jul 14, 2023Alexion, AstraZeneca
NCT05886244Phase 3Jul 5, 2023Alexion, AstraZeneca
NCT05863442Phase 1Apr 10, 2023Turgut Ardika PTY LTD
NCT05702996Phase 3Mar 31, 2023Rouen Normandy University
NCT05646563Phase 2Feb 28, 2023NovelMed Therapeutics
NCT05131204Phase 3Mar 31, 2022Regeneron
NCT05116774Phase 2Nov 30, 2021BioCryst, University of London
NCT04859608Phase 4Nov 1, 2021University Hospital, Tours
Showing 20 of 104 trials
Page 1 / 6

Organizations

Research & Development (66)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AlexionFor profit563952002
Mayo ClinicAcademic/Hospital4422008
AstraZenecaFor profit3012023
BiocadFor profit3322018
National Heart, Lung, and Blood Institute (NHLBI)Government3322004
AO GENERIUMFor profit2212017
Assistance Publique - Hôpitaux de ParisAcademic/Hospital2222020
Cedars-Sinai Medical CenterAcademic/Hospital2222012
ChugaiFor profit2012020
Harvard UniversityAcademic/Hospital2222013
Icahn School of Medicine at Mount SinaiAcademic/Hospital2012011
Johns Hopkins UniversityAcademic/Hospital2222009
National Institutes of Health (NIH)Government2022011
Procter and GambleFor profit2112004
RocheFor profit2212020
SamsungFor profit2222018
Tianjin Medical UniversityAcademic/Hospital2212024
Yale UniversityAcademic/Hospital2212011
Achillion PharmaceuticalsFor profit1112018
AmgenFor profit1112019
66 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
AlexionFor profitMKTGMar 16, 2007
AlexionFor profitNDAMar 16, 2007
AmgenFor profitMKTGMay 28, 2024
SamsungFor profitMKTGJul 19, 2024