NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
3/8 — Basic
Priority Review
TRISENOX (arsenic trioxide) by Teva is understood. First approved in 2000.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRISENOX (arsenic trioxide) is an injectable small molecule indicated for acute promyelocytic leukemia (APL), a rare hematologic malignancy. It induces apoptosis and degrades the PML-RAR-alpha fusion protein characteristic of APL cells. The drug has been a standard-of-care treatment since its 2000 approval.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure; commercial teams should expect eventual transition planning and potential headcount shifts toward LOE mitigation strategies.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Started Dec 2017
5 enrolled
Acute Myeloid LeukemiaRelapsed/Refractory Acute Myeloid Leukemia
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
Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL
Started Jun 2012
738 enrolled
Acute Promyelocytic Leukemia
Arsenic Trioxide and Tyrosine Kinase Inhibitors for Chronic Myelogenous Leukemia (CML)
Started Sep 2011
7 enrolled
Chronic Myelogenous Leukemia
Study of Arsenic Trioxide in Small Cell Lung Cancer
Started Aug 2011
20 enrolled
Lung CancerCancer of LungPulmonary Cancer+2 more
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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.