Drug · Monoclonal Antibody
Rituximab
CI-DRUG-00000703Explore in graph →CHEMBL1201576 Approved
Regulatory
Approvals (37)
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 2021-12-02 (see label) | approved | Dec 2, 2021 | openfda |
| US FDA | — | Efficacy supplement 2020-08-28 (see label) | approved | Aug 28, 2020 | openfda |
| US FDA | — | Efficacy supplement 2019-09-27 (see label) | approved | Sep 27, 2019 | openfda |
| US FDA | — | Efficacy supplement 2019-01-25 (see label) | approved | Jan 25, 2019 | 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 16 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 | 334 | 143 | 247 | 1,358 | 37 | CA, EU, US | Nov 26, 1997 | May 8, 1993 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 226 | 94 | 148 | 743 | 2 | EU, US | Nov 26, 1997 | May 8, 1993 |
| Leukemia | Phase4 | Phase 4 | 60 | 29 | 44 | 307 | 0 | — | — | 1997-09 |
| Malignant Central Nervous System Neoplasm | Phase3 | Phase 3 | 16 | 10 | 1 | 35 | 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 (1,384)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT01902862 | An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma | terminated | Phase 2 | 7 | Janssen-Cilag G.m.b.HINDUSTRY | 1 | Apr 1, 2014 | clinicaltrials |
| NCT00556699 | A Study of SGN-40 in Combination With Rituximab in Patients With CD20-Positive, Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma |