Drug · Monoclonal Antibody
Ofatumumab
CI-DRUG-00000715Explore in graph →CHEMBL1201836 Approved
Regulatory
Approvals (8)
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 2020-08-20 (see label) | approved | Aug 20, 2020 | openfda |
| US FDA | — | Efficacy supplement 2016-08-30 (see label) | approved | Aug 30, 2016 | openfda |
| US FDA | — | Efficacy supplement 2016-01-19 (see label) | approved | Jan 19, 2016 | openfda |
| US FDA | — | Efficacy supplement 2014-04-17 (see label) | approved | Apr 17, 2014 | 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 18 hours 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 | 4 | 3 | 12 | 81 | 8 | CA, EU, US | Oct 26, 2009 | 2004-09 |
| Non-Hodgkin Lymphoma | Phase3 | Phase 3 | 2 | 2 | 5 | 41 | 0 | — | — | 2004-09 |
| Hodgkin Lymphoma | Phase2 | Phase 2 | 0 | 0 | 0 | 2 | 0 | — | — | 2010-07 |
| Leukemia | Withdrawn | Phase 4 | 3 | 2 | 8 | 45 | 1 | EU | — |
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 (82)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00742144 | Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia | completed | Phase 1 | 6 | GlaxoSmithKlineINDUSTRY | 1 | Nov 17, 2017 | clinicaltrials |
| NCT01110031 | Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects | completed | Phase 1 |