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IV Arsenic Trioxide
Arsenic trioxide induces differentiation and apoptosis of leukemic cells, particularly in acute promyelocytic leukemia, through multiple pathways including PML-RARA degradation and reactive oxygen species generation.
Arsenic trioxide induces differentiation and apoptosis of leukemic cells, particularly in acute promyelocytic leukemia, through multiple pathways including PML-RARA degradation and reactive oxygen species generation. Used for Acute promyelocytic leukemia (APL), newly diagnosed and relapsed/refractory.
At a glance
| Generic name | IV Arsenic Trioxide |
|---|---|
| Sponsor | SDK Therapeutics, Inc. |
| Drug class | Arsenic compound; differentiation agent and apoptosis inducer |
| Target | PML-RARA fusion protein; mitochondrial apoptotic pathway |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Arsenic trioxide targets the PML-RARA fusion protein characteristic of acute promyelocytic leukemia (APL), causing its degradation and leading to differentiation of abnormal promyelocytes into mature granulocytes. At higher concentrations, it also triggers apoptosis through mitochondrial pathways and generation of reactive oxygen species. This dual mechanism of differentiation and cell death makes it highly effective in APL and potentially useful in other hematologic malignancies.
Approved indications
- Acute promyelocytic leukemia (APL), newly diagnosed and relapsed/refractory
Common side effects
- Differentiation syndrome (APL differentiation syndrome)
- QT prolongation
- Hyperglycemia
- Leukocytosis
- Nausea and vomiting
- Fatigue
- Peripheral neuropathy
- Hepatotoxicity
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)
- 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)
- Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS) (PHASE1)
- Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma (PHASE2)
- Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma (PHASE2)
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 |
|---|---|
| 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:
- IV Arsenic Trioxide CI brief — competitive landscape report
- IV Arsenic Trioxide updates RSS · CI watch RSS
- SDK Therapeutics, Inc. portfolio CI