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Trisenox (ARSENIC TRIOXIDE)
Trisenox (Arsenic Trioxide) is a small molecule drug originally developed by Cephalon and currently owned by the same company. It targets the potassium voltage-gated channel subfamily H member 2 and is classified as a high-risk QT prolonging agent. Trisenox is FDA-approved for the treatment of acute myelomonocytic leukemia (FAB M4) and acute promyelocytic leukemia (FAB M3). The drug is off-patent and has multiple generic manufacturers. Key safety considerations include its potential to prolong the QT interval, which can increase the risk of serious cardiac arrhythmias.
At a glance
| Generic name | ARSENIC TRIOXIDE |
|---|---|
| Sponsor | Cephalon |
| Drug class | High Risk QT Prolonging Agents |
| Target | Potassium voltage-gated channel subfamily H member 2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2000 |
Approved indications
- Acute myelomonocytic leukemia, FAB M4
- Acute promyelocytic leukemia, FAB M3
Common side effects
- Nausea
- Cough
- Fatigue
- Pyrexia
- Headache
- Abdominal pain
- Vomiting
- Tachycardia
- Diarrhea
- Dyspnea
- Hypokalemia
- Leukocytosis
Serious adverse events
- Thrombocytopenia > 15 days (Grade 3-4)
- Hepatic toxicity (Grade 3-4)
- Neutropenia > 15 days (Grade 3-4)
- Infection and fever of unknown origin
- Hypertriglyceridemia
- QT prolongation
- Differentiation syndrome
- Pneumonia
- Abnormal liver tests
Drug interactions
- High Risk QT Prolonging Agents
- ziprasidone
Key clinical trials
- Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia (PHASE3)
- ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma. (PHASE1)
- Continuous Versus Intermittent cARdiac Electrical moNitorinG (NA)
- A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301) (PHASE3)
- Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia (PHASE2)
- Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia (PHASE1)
- Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia (NA)
- Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trisenox CI brief — competitive landscape report
- Trisenox updates RSS · CI watch RSS
- Cephalon portfolio CI