Drug · Monoclonal Antibody
Obinutuzumab
CI-DRUG-00000722Explore in graph →CHEMBL1743048 Approved
Regulatory
Approvals (13)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2025-10-17 (see label) | approved | Oct 17, 2025 | openfda |
| US FDA | — | Efficacy supplement 2025-10-17 (see label) | approved | Oct 17, 2025 | openfda |
| US FDA | — | Efficacy supplement 2022-02-14 (see label) | approved | Feb 14, 2022 | openfda |
| US FDA | — | Efficacy supplement 2020-03-27 (see label) | approved | Mar 27, 2020 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 124 | 53 | 36 | 251 | 13 | CA, EU, US | Nov 1, 2013 | 2007-09 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 79 | 34 | 16 | 142 | 2 | US | Nov 1, 2013 | 2008-01 |
| Leukemia | Approved | Phase 3 | 48 | 23 | 22 | 90 | 1 | US | Nov 1, 2013 | Dec 21, 2009 |
| Malignant Central Nervous System Neoplasm | Phase2 | Phase 2 | 2 | 1 | 0 | 4 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (259)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT03223610 | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma | recruiting | Phase 1 / Phase 2 | 155 | National Cancer Institute (NCI)NIH | 1 | Sep 28, 2026 | clinicaltrials |
| NCT03462719 | A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |