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obinutuzumab

Trade name: gazyva

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Nov 1, 2013

Obinutuzumab, sold under the brand name Gazyva among others, is a humanized anti-CD20 monoclonal antibody used as a treatment for cancer. It was originated by GlycArt Biotechnology AG and developed by Roche. — Wikipedia

Clinical trial activity

286 trials · 156 clinical orgs · 2 marketing orgs

Phase 1
94
Phase 2
211
Phase 3
42
Phase 4
1

Earliest trial started Sep 1, 2007 (NCT00517530)

Timeline

2000s

  1. Jan 1, 2007

    Roche — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Roche — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2009

    Roche — Earliest Phase 3 Sponsor(trial)

2010s

  1. Feb 17, 2012

    Orphan Drug Designation

  2. Oct 3, 2013

    Genentech — First NDA Organization

  3. Oct 3, 2013

    Genentech — NDA Organization

  4. Nov 1, 2013

    Earliest FDA Approval

  5. Nov 1, 2013

    Genentech — Marketing Organization

  6. Nov 1, 2013

    Roche — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughNov 1, 2013

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 warning

Sources

Also known as

  • afutuzumab
  • afutuzumab
  • afutuzumab
  • ga101
  • ga101
  • ga101
  • ga101
  • ga 101
  • ga 101
  • ga-101
  • ga101 antibody
  • gazyva
  • gazyva
  • gazyva
  • gazyva
  • gazyvaro
  • gazyvaro
  • gazyvaro
  • humabcd20
  • humab<cd20>
  • humab<cd20>
  • immunoglobulin g1, anti-(human cd20 (antigen)) (human-mouse monoclonal ga101 heavy chain), disulfide with human-mouse monoclonal ga101 kappa-chain, dimer
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • obinutuzumab
  • r 7159
  • r-7159
  • r-7159
  • r7159 cpd
  • rg-7159
  • ro5072759
  • ro5072759
  • ro 5072759
  • ro 5072759
  • ro-5072759
  • ro-5072759
  • ro-5072759
  • ro-5072759 humab<cd20>

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07233330Phase 2Feb 28, 2026Mario Negri Institute
NCT07299149Phase 2Dec 25, 2025China Academy of Chinese Medical Sciences
NCT07261163Phase 2Dec 20, 2025China Academy of Chinese Medical Sciences
NCT07218510Phase 2Dec 9, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07268521Phase 2Dec 1, 2025Assistance Publique - Hôpitaux de Paris
NCT07003295Phase 2Oct 31, 2025Johns Hopkins University, National Cancer Institute (NCI)
NCT07107490Phase 1Oct 8, 2025Chugai
NCT07163611Phase 2/Phase 3 (Phase 3)Oct 1, 2025Radboud University, Roche
NCT07240194Phase 2Sep 1, 2025Nanjing Medical University
NCT06922604Phase 1Jul 30, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06849713Phase 2Jul 28, 2025BeOne Medicines, Harvard University
NCT07126678N/AJul 15, 2025Nanjing Medical University
NCT06916767Phase 1Jul 15, 2025Case Western Reserve University, The Leukemia and Lymphoma Society
NCT06967610Phase 2Jul 15, 2025Eli Lilly, University of Texas at Houston
NCT06940661Phase 2Jun 30, 2025Assistance Publique - Hôpitaux de Paris
NCT07003464Phase 2Jun 15, 2025Jinlin University
NCT06943872Phase 3Jun 11, 2025BeOne Medicines, German CLL Study Group
NCT06978088Phase 2Jun 1, 2025Newave Pharmaceutical Inc, University of Cincinnati
NCT06961500Phase 2May 1, 2025Sun Yat-Sen University
NCT06918015Phase 2May 1, 2025Chinese Academy of Medical Sciences
Showing 20 of 286 trials
Page 1 / 15

Organizations

Research & Development (156)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit845652007
GenentechFor profit511132009
National Cancer Institute (NCI)Government251132015
German CLL Study GroupAcademic/Hospital18922009
Harvard UniversityAcademic/Hospital121022015
University of Texas at HoustonAcademic/Hospital121212014
AbbVieFor profit10532012
CelgeneFor profit10422014
China Academy of Chinese Medical SciencesAcademic/Hospital9922022
AstraZenecaFor profit8242017
BeOne MedicinesFor profit8432015
PharmacyclicsFor profit8132014
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital7722018
Fondazione Italiana Diabete OnlusAcademic/Hospital6522011
Mayo ClinicAcademic/Hospital6522013
Nanjing Medical UniversityAcademic/Hospital6522022
The Lymphoma Academic Research OrganisationAcademic/Hospital6622012
Gilead SciencesFor profit5432015
Oregon Health and Science UniversityAcademic/Hospital5322016
University of California, San DiegoAcademic/Hospital5522014
156 organizations
Page 1 / 8

Marketing (3)

OrganizationOrg typeRelationshipDate
GenentechFor profitMKTGNov 1, 2013
GenentechFor profitNDAOct 3, 2013
RocheFor profitNDA2Nov 1, 2013