Drug · Small Molecule
Arsenic Trioxide
CI-DRUG-00000080Explore in graph →NCIt C1005 CHEMBL5483015 CIViC Approved
Regulatory
Approvals (18)
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
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as ARSENIC TRIOXIDE FOR INJECTION (DIN 02554364) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 27, 2025 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as ARSENIC TRIOXIDE FOR INJECTION (DIN 02513420) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 11, 2022 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as TRISENOX (DIN 02480387) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Apr 18, 2023 |
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 8 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 | 13 | 6 | 11 | 112 | 18 | CA, EU, US | Sep 25, 2000 | 1997-11 |
| Leukemia | Approved | Phase 4 | 9 | 4 | 10 | 59 | 5 | EU, US | Sep 25, 2000 | 1997-11 |
| Malignant Liver Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 5 | 0 | — | — | 2001-03 |
| Malignant Pancreatic Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 2 | 0 | — |
Curated evidence
Clinical evidence (6)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 11704842
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| RARA Fusion1 | ||||||||
| Arsenic Trioxide + Tretinoin | ||||||||
Clinical trials
Trials with this intervention (113)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT07737769 | Arsenic Trioxide to Prevent Relapse in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia or Myelodysplastic Syndrome | not yet recruiting | Phase 1 | 20 | University of Michigan Rogel Cancer CenterOTHER | 1 | Jul 30, 2026 | clinicaltrials |
| NCT02688140 | Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia(TUD-APOLLO-064) |