CDEK
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inebilizumab

Trade name: Uplizna

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Jun 11, 2020

Inebilizumab, sold under the brand name Uplizna, is a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults and IgG4-RD. Inebilizumab is a humanized mAb that binds to and depletes CD19+ B cells including plasmablasts and plasma cells. — Wikipedia

Clinical trial activity

28 trials · 15 clinical orgs · 2 marketing orgs

Phase 1
6
Phase 2
17
Phase 3
8
Phase 4
3

Earliest trial started Mar 1, 2010 (NCT00946699)

Timeline

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

  3. Feb 10, 2016

    Orphan Drug Designation

  4. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jun 11, 2020

    Horizon Therapeutics, LLC — Earliest FDA Approval

  2. Jun 11, 2020

    Viela Bio — Marketing Organization

  3. Jun 11, 2020

    Horizon Therapeutics, LLC — NDA Secondary Org

  4. Jun 11, 2020

    Horizon Therapeutics, LLC — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughJun 11, 2020

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

  • 188-0551
  • inebilizumab
  • inebilizumab
  • medi-551
  • medi-551

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06987539Phase 2Apr 30, 2026Amgen
NCT07222553Phase 2Feb 27, 2026Amgen
NCT07010302Phase 4Nov 30, 2025Harvard University, Humboldt University, Patient-Centered Outcomes Research Institute
NCT07159893N/ASep 30, 2025Wenzhou Medical University
NCT07132398Phase 3Sep 1, 2025Tianjin Medical University
NCT06570798Phase 2Oct 31, 2024Amgen
NCT06212245Phase 4Feb 25, 2024Horizon Therapeutics, LLC, Jiangsu Hansoh Pharmaceutical Co., Ltd.
NCT06180278Phase 4Jan 31, 2024Horizon Therapeutics, LLC
NCT05549258Phase 2Aug 25, 2022Horizon Therapeutics, LLC
NCT05198557Phase 3Jul 20, 2022Mitsubishi Tanabe
NCT04372615Phase 2/Phase 3 (Phase 3)Jan 31, 2021University of Utah
NCT04540497Phase 3Oct 26, 2020Viela Bio
NCT04524273Phase 3Aug 30, 2020Viela Bio
NCT04174677Phase 2Dec 31, 2019Viela Bio
NCT04080206Phase 2Oct 31, 2019Therapeutics, Inc.
NCT03759197Phase 3Nov 26, 2018Therapeutics, Inc.
NCT03731052Phase 3Oct 16, 2018Therapeutics, Inc.
NCT03218163Phase 2Sep 27, 2017Johns Hopkins University
NCT03065556Phase 2Jan 26, 2017Therapeutics, Inc.
NCT02200770Phase 2/Phase 3 (Phase 3)Jan 6, 2015MedImmune
Showing 20 of 28 trials
Page 1 / 2

Organizations

Research & Development (15)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MedImmuneFor profit9732010
Therapeutics, Inc.For profit4422017
AmgenFor profit3312024
Horizon Therapeutics, LLCFor profit3222022
Viela BioFor profit3322019
Johns Hopkins UniversityAcademic/Hospital2222014
AstraZenecaFor profit1112011
Harvard UniversityAcademic/Hospital1112025
Humboldt UniversityAcademic/Hospital1012025
Jiangsu Hansoh Pharmaceutical Co., Ltd.For profit1112024
Mitsubishi TanabeFor profit1112022
Patient-Centered Outcomes Research InstituteAcademic/Hospital1012025
Tianjin Medical UniversityAcademic/Hospital1112025
University of UtahAcademic/Hospital1112021
Wenzhou Medical UniversityAcademic/Hospital1112025
15 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Horizon Therapeutics, LLCFor profitNDA2Jun 11, 2020
Horizon Therapeutics, LLCFor profitNDAJun 11, 2020
Viela BioFor profitMKTGJun 11, 2020