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
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-24
- Retrieved
- Sep 28, 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-20260928-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. • Relapsed or Refractory APL Arsenic Trioxide Injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. | approved | Aug 31, 2018 | openfda |
| US FDA | — | Efficacy supplement 2018-01-12 (see label) | approved | Jan 12, 2018 | openfda |
| US FDA | Acute Promyelocytic Leukemia | In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. | approved | Sep 25, 2000 | 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 14 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) |