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ocrelizumab

Trade name: ocrevus

mAbapprovedFast Track FDABreakthrough Therapy FDA

Approved

Mar 28, 2017

Ocrelizumab, sold under the brand name Ocrevus, is a medication used for the treatment of multiple sclerosis. It is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and is an immunosuppressive drug. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds. It is administered by intravenous infusion. The fixed-dose combination ocrelizumab/hyaluronidase is administered by subcutaneous injection. — Wikipedia

Clinical trial activity

71 trials · 57 clinical orgs · 2 marketing orgs

Phase 1
6
Phase 2
51
Phase 3
38
Phase 4
15

Earliest trial started Feb 1, 2004 (NCT00077870)

Timeline

2000s

  1. Jan 1, 2004

    Genentech — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    Genentech — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Genentech — Earliest Phase 2 Sponsor(trial)

2010s

  1. Mar 28, 2017

    Roche — Earliest FDA Approval

  2. Mar 28, 2017

    Genentech — Marketing Organization

  3. Mar 28, 2017

    Roche — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • B-lymphocyte antigen CD20BINDING AGENT

    B-lymphocyte antigen CD20 binding agent

    Humanized monoclonal antibody designed to target CD20-positive B cells, which are implicated in the inflammatory and neurodegenerative processes of multiple sclerosis. By targeting CD20-positive B cells, this molecule depletes (antibody-dependent cell-mediated cytotoxicity) pre-B cells and mature B cells without affecting plasma cells or progenitor cells in the bone marrow.

  • B-lymphocyte antigen CD20INHIBITOR

    MS4A1 inhibitor

  • B-lymphocyte antigen CD20OTHER

    MS4A1 other

    Humanized monoclonal antibody designed to target CD20-positive B cells, which are implicated in the inflammatory and neurodegenerative processes of multiple sclerosis. By targeting CD20-positive B cells, this molecule depletes (antibody-dependent cell-mediated cytotoxicity) pre-B cells and mature B cells without affecting plasma cells or progenitor cells in the bone marrow.

Approval history

  • approvedPriority reviewFast trackBreakthroughMar 28, 2017

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

  • 2h7
  • 2h7
  • ocrelizumab
  • ocrelizumab
  • ocrelizumab
  • ocrelizumab
  • ocrelizumab
  • ocrelizumab
  • ocrelizumab
  • ocrelizumab
  • ocrevus
  • pr070769
  • pr 070769
  • pr-070769
  • pr-070769
  • pr-070769
  • r1594
  • r 1594
  • r-1594
  • r-1594
  • r-1594
  • rg-1594

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07282574Phase 2Jan 30, 2026Roche
NCT07074886Phase 2Nov 13, 2025Roche
NCT07181811N/ASep 30, 2025Department of Veteran Affairs, Genentech
NCT07189325Phase 3Sep 30, 2025University of Montpellier
NCT06846281Phase 3Jun 16, 2025Novartis
NCT06847724Phase 3Apr 14, 2025Sandoz
NCT06675955Phase 3Dec 9, 2024Roche
NCT06700343Phase 3Dec 6, 2024Amgen
NCT06677710Phase 1Nov 1, 2024Indapta Therapeutics, INC.
NCT06495593Phase 4Oct 1, 2024Genentech, University of California, San Francisco
NCT05906992Phase 3Dec 31, 2023Celltrion
NCT05999604Phase 3Nov 9, 2023Adolphe Rothschild Ophtalmologic Foundation
NCT05758831Phase 3Jun 1, 2023University of Rennes
NCT05208840Phase 4Feb 14, 2023Roche
NCT05285891Phase 4Dec 16, 2022Genentech, National Institute of Allergy and Infectious Diseases (NIAID), Rho, Inc., University of Pennsylvania
NCT05269004Phase 3May 3, 2022Roche
NCT05232825Phase 3May 2, 2022Roche
NCT05296161Phase 4Apr 20, 2022Free University of Amsterdam, University of Amsterdam
NCT05210621Phase 3Mar 8, 2022University of Nice Sophia Antipolis
NCT05123703Phase 3Jan 31, 2022PPD, Roche
Showing 20 of 71 trials
Page 1 / 4

Organizations

Research & Development (57)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit392652005
GenentechFor profit231442004
Johns Hopkins UniversityAcademic/Hospital3322019
PPDFor profit3022021
LabCorpFor profit2012021
University of California, San FranciscoAcademic/Hospital2212020
University of Colorado, DenverAcademic/Hospital2222017
Aalborg UniversityAcademic/Hospital1012021
Aarhus UniversityAcademic/Hospital1012021
Adolphe Rothschild Ophtalmologic FoundationAcademic/Hospital1112023
AmgenFor profit1112024
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112018
CelltrionFor profit1112023
Central Jutland Regional HospitalAcademic/Hospital1012021
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaAcademic/Hospital1112020
ChugaiFor profit1112008
CinnagenFor profit1112019
CTC Bio, Inc.For profit1012021
Danske RegionerGovernment1012021
Department of Veteran AffairsGovernment1112025
57 organizations
Page 1 / 3

Marketing (2)

OrganizationOrg typeRelationshipDate
GenentechFor profitMKTGMar 28, 2017
RocheFor profitNDAMar 28, 2017