CDEK
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ravulizumab-cwvz

Trade name: ultomiris

mAbapprovedCOVID-19Orphan Drug FDA

Approved

Dec 21, 2018

Ravulizumab, sold under the brand name Ultomiris, is a humanized monoclonal antibody complement inhibitor medication designed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome. It is designed to bind to and prevent the activation of complement component 5 (C5). — Wikipedia

Clinical trial activity

42 trials · 11 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
30
Phase 3
26
Phase 4
5

Earliest trial started Aug 27, 2014 (NCT05288660)

Timeline

2010s

  1. Jun 24, 2013

    Orphan Drug Designation

  2. Jan 1, 2014

    Alexion — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2015

    Alexion — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2016

    Alexion — Earliest Phase 3 Sponsor(trial)

  5. Dec 21, 2018

    Alexion — Earliest FDA Approval

  6. Dec 21, 2018

    Alexion — Marketing Organization

  7. Dec 21, 2018

    Alexion — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 21, 2018

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • alxn1210
  • ravulizumab-cwvz

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07221838Phase 4Dec 31, 2025Alexion
NCT07308574Phase 4Dec 26, 2025Alexion
NCT07010302Phase 4Nov 30, 2025Harvard University, Humboldt University, Patient-Centered Outcomes Research Institute
NCT07024563Phase 3Jun 14, 2025Alexion
NCT06830798Phase 3May 30, 2025Alexion
NCT06333652Phase 2Dec 1, 2024Mayo Clinic
NCT06578949Phase 3Oct 10, 2024Alexion
NCT06291376Phase 3Mar 29, 2024Alexion
NCT05746559Phase 3Apr 6, 2023Alexion
NCT05972967Phase 2Mar 27, 2023Omeros Corporation
NCT05644561Phase 3Jan 2, 2023Alexion
NCT05133531Phase 3Jul 31, 2022Regeneron
NCT05346354Phase 2/Phase 3 (Phase 3)Jun 23, 2022Alexion
NCT05131204Phase 3Mar 31, 2022Regeneron
NCT05116774Phase 2Nov 30, 2021BioCryst, University of London
NCT04999020Phase 2/Phase 3 (Phase 3)Nov 15, 2021Alexion
NCT04743804Phase 3Apr 30, 2021Alexion
NCT04469465Phase 3Dec 31, 2020Alexion
NCT04564339Phase 2Dec 31, 2020Alexion
NCT04558918Phase 3Dec 15, 2020Novartis
Showing 20 of 42 trials
Page 1 / 3

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AlexionFor profit333342014
Harvard UniversityAcademic/Hospital2222020
RegeneronFor profit2212022
BioCrystFor profit1112021
Humboldt UniversityAcademic/Hospital1012025
Mayo ClinicAcademic/Hospital1112024
NovartisFor profit1112020
Omeros CorporationFor profit1112023
Patient-Centered Outcomes Research InstituteAcademic/Hospital1012025
University of CambridgeAcademic/Hospital1112020
University of LondonAcademic/Hospital1012021
11 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
AlexionFor profitMKTGDec 21, 2018
AlexionFor profitNDADec 21, 2018