ARSENIC TRIOXIDE

Post-LOE

arsenic trioxide

Teva

ANDAINJECTIONINJECTABLE

Approved

Oct 2021

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

ARSENIC TRIOXIDE (arsenic trioxide) by Teva is understood. Approved for 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, leukemia, combination with tretinoin. First approved in 2021.

Drug data last refreshed 22h ago

Mechanism of Action

understood. Arsenic trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukemia (PML)-retinoic acid receptor (RAR)-alpha.

Indications (3)

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 leukemia

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (12)

NCT03318016Phase 1Terminated

Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Started Dec 2017

5 enrolled

Acute Myeloid LeukemiaRelapsed/Refractory Acute Myeloid Leukemia

NCT02066870Phase 1Unknown

Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI

Started Jan 2014

9 enrolled

Non-small Cell Lung Cancer

NCT01987297Phase 4Unknown

Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL

Started Jun 2012

738 enrolled

Acute Promyelocytic Leukemia

NCT01397734Phase 1Terminated

Arsenic Trioxide and Tyrosine Kinase Inhibitors for Chronic Myelogenous Leukemia (CML)

Started Sep 2011

7 enrolled

Chronic Myelogenous Leukemia

NCT01470248Phase 2Completed

Study of Arsenic Trioxide in Small Cell Lung Cancer

Started Aug 2011

20 enrolled

Lung CancerCancer of LungPulmonary Cancer+2 more