Drug · Adc
Inotuzumab Ozogamicin
CI-DRUG-00000730Explore in graph →CHEMBL2108611 Approved
Regulatory
Approvals (4)
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 2024-03-06 (see label) | approved | Mar 6, 2024 | openfda |
| US FDA | Acute Lymphoblastic Leukemia | 1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. ( 1 ) | approved | Aug 17, 2017 | openfda |
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 | 24 | 14 | 6 | 51 | 4 | CA, EU, US | Jun 28, 2017 | 2003-08 |
| Leukemia | Approved | Phase 4 | 21 | 13 | 4 | 36 | 2 | EU, US | Jun 28, 2017 | 2011-08 |
| Non-Hodgkin Lymphoma | Phase3 | Phase 3 | 5 | 3 | 3 | 10 | 0 | — | — | 2007-11 |
| Malignant Central Nervous System Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 1 | 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 (55)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT00867087 | Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma | completed | Phase 2 | 64 | PfizerINDUSTRY | 6 | Dec 5, 2017 | clinicaltrials |
| NCT00868608 | Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma | completed | Phase 2 | 81 |