Wednesday, July 8, 2026

Drug profile · INN

obinutuzumab

obinutuzumab (GAZYVA) is a b-lymphocyte antigen cd20 binding agent. Associated with Hoffmann-La Roche. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01FA03
US status approved
Patents linked 14
Pipeline programs 47
News articles 0
Drug details — obinutuzumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
14
Programs
47
Data quality
0.84

Quick answer

obinutuzumab (GAZYVA) is a b-lymphocyte antigen cd20 binding agent. Associated with Hoffmann-La Roche. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN obinutuzumab
Brand GAZYVA
Mechanism B-lymphocyte antigen CD20 binding agent
Target B-lymphocyte antigen CD20
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation INJECTABLE
ATC code L01FA03

Mechanism of action

B-lymphocyte antigen CD20 binding agent

Primary target: B-lymphocyte antigen CD20

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. ACE-CL-007 Phase 3 · Anaxis Pharma · Chronic Lymphocytic Leukemia
  2. ACE-CL-311 (AMPLIFY) Phase 3 · Anaxis Pharma · Previously untreated Chronic Lymphocytic Leukemia Without de
  3. APHP200038 Phase 3 · PARItec · lupus nephritis
  4. BGB-11417 for Previously Untreated Chronic Lymphocytic Leukemia Phase 3 · BEONE MEDICINES AUS · Previously Untreated Chronic Lymphocytic Leukemia
  5. BGB-11417-303CLL-RR1 Phase 3 · BEONE MEDICINES AUS · Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymph
  6. BO25323 Phase 3 · HOFFMANN-LA ROCHE · Chronic Lymphocytic Leukemia (CLL)
  7. CA41705 Phase 3 · HOFFMANN-LA ROCHE · Lupus Nephritis (LN)
  8. CA42750 Phase 3 · HOFFMANN-LA ROCHE · Systemic Lupus Erythematosus (SLE)

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. WO 2025252204

    DISPERSIONS SOLIDES AMORPHES D'UN INHIBITEUR DE BRAF

    Expires Wed Dec 06 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. WO 2025232885

    PROCÉDÉ DE PRÉPARATION D'UN AGENT DE DÉGRADATION DE LA TYROSINE KINASE DE BRUTON

    Expires Wed Nov 08 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. WO 2025218772

    FORMES SOLIDES COMPRENANT UN AGENT DE DÉGRADATION DE TYROSINE KINASE DE BRUTON ET LEURS UTILISATIONS

    Expires Wed Oct 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. WO 2025214466

    CONJUGUÉS DE PYRROLOBENZODIAZÉPINE CIBLÉS

    Expires Wed Oct 11 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. WO 2025201453

    COMPOSÉS MACROCYCLIQUES UTILISÉS EN TANT QU'INHIBITEURS DE RAS

    Expires Wed Sep 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. WO 2025168081

    TRAITEMENT D'UN TROUBLE PROLIFÉRATIF DES LYMPHOCYTES B AVEC UN COMPOSÉ ACTIVATEUR DE DÉGRADATION CHIMÉRIQUE

    Expires Wed Aug 09 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. WO 2025168072

    COMPOSÉS HÉTÉROCYCLIQUES, COMPOSITIONS ASSOCIÉES ET MÉTHODES DE TRAITEMENT ASSOCIÉS

    Expires Wed Aug 09 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. WO 2025126115

    DÉGRADATION DE L'IRAK4 PAR CONJUGAISON D'INHIBITEURS D'IRAK4 AVEC DES LIGANDS DE LIGASE E3 ET PROCÉDÉS D'UTILISATION

    Expires Wed Jun 14 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. WO 2025108443

    COMPOSÉS HÉTÉROCYCLIQUES ET COMPOSITIONS ASSOCIÉES, ET MÉTHODES DE TRAITEMENT CORRESPONDANTES

    Expires Thu May 25 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. WO 2025078995

    COMPOSÉS DE 6-(PYRIMIDIN-4-YL)QUINOLÉINE SUBSTITUÉS UTILISÉS EN TANT QU'INHIBITEURS DE KINASE DÉPENDANTE DE LA CYCLINE

    Expires Wed Apr 12 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. WO 2025068985

    DÉRIVÉS DE 1-(1-OXO-1,2-DIHYDROPHTALAZIN-6-YL)CYCLOALKYL-1-CARBOXAMIDE UTILISÉS EN TANT QU'INHIBITEURS COOPÉRATIFS DE MTA DE PRMT5

    Expires Wed Mar 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. WO 2025062334

    DÉRIVÉS DE 4-((5-(3-(4-(PYRIDIN-2-YL)CYCLOPENTYL)-1 H-PYRAZOL-3-YL)AMINO)-BENZÈNESULFONAMIDE ET COMPOSÉS SIMILAIRES UTILISÉS COMME INHIBITEURS DE CDK POUR LE TRAITEMENT DU CANCER

    Expires Wed Mar 22 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. WO 2025052303

    ARN CIRCULAIRE ET PROCÉDÉS DE PRÉPARATION ASSOCIÉS

    Expires Wed Mar 08 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. WO 2025041076

    COMPOSÉS BICYCLIQUES UTILISÉS EN TANT QU'INHIBITEURS DE CDK

    Expires Wed Feb 22 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is obinutuzumab?

obinutuzumab (GAZYVA) is a b-lymphocyte antigen cd20 binding agent. Associated with Hoffmann-La Roche. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for obinutuzumab?

GAZYVA is a marketed brand name for obinutuzumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of obinutuzumab?

obinutuzumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.