TRISENOX (arsenic trioxide)
Trisenox is an arsenical indicated for use in combination with tretinoin for the treatment of adults with newly-diagnosed, low-risk acute promyelocytic leukemia (APL). It is also indicated for the induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy. In both indications, the APL must be characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
How TRISENOX Works
The exact mechanism of action of Trisenox is not completely understood. In vitro, arsenic trioxide induces morphological changes and DNA fragmentation characteristic of apoptosis (programmed cell death) in human promyelocytic leukemia cells. It also facilitates the damage or degradation of the PML/RAR-alpha fusion protein, a key driver of the disease.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-09-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TRISENOX Approval History
What TRISENOX Treats
1 indicationsTRISENOX is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Promyelocytic Leukemia
TRISENOX Boxed Warning
DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES AND ENCEPHALOPATHY INCLUDING WERNICKE'S Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with TRISENOX have experienced differentiation syndrome, which may be life-threatening or fatal. Signs and symptoms may include unexplained fever, dyspnea, hypoxia, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain, peripheral edema, hypotension, renal insufficiency, hep...
WARNING: DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES AND ENCEPHALOPATHY INCLUDING WERNICKE'S Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with TRISENOX have experienced differentiation syndrome, which may be life-threatening or fatal. Signs and symptoms may include unexplained fever, dyspnea, hypoxia, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain, peripheral edema, hypotension, renal insufficiency, hepatopathy, and multi-organ dysfunction, in the presence or absence of leukocytosis. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroids and hemodynamic monitoring until resolution. Temporarily withhold TRISENOX [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )]. Cardiac Conduction Abnormalities: TRISENOX can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal. Before administering TRISENOX, assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer TRISENOX to patients with a ventricular arrhythmia or prolonged QTc interval. Withhold TRISENOX until resolution and resume at reduced dose for QTc prolongation [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.2 )]. Encephalopathy: Serious encephalopathy, including Wernicke's, has occurred with TRISENOX. Wernicke's is a neurologic emergency. Consider testing thiamine levels in patients at risk for thiamine deficiency. Administer parenteral thiamine in patients with or at risk for thiamine deficiency. Monitor patients for neurological symptoms and nutritional status while receiving TRISENOX. If Wernicke's encephalopathy is suspected, immediately interrupt TRISENOX and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize [see Warnings and Precautions ( 5.3 )] . W
TRISENOX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TRISENOX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRISENOX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TRISENOX
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
24 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01409161 | 2010-0981 NCI-2011-02767, 2010-0981 | Ph 2 | recruiting | Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia |
| NCT02339740 results posted | AAML1331 NCI-2014-02266, PAAML1331_A01PAMDREVW0 | Ph 3 | active not recruiting | Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia |
| NCT03031249 | IIT2016007（ATO + ATRA） | Ph 1, Ph 2 | enrolling by invitation | Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia |
| NCT03503864 results posted | SYS-C-202007 | Ph 2 | active not recruiting | Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma |
| NCT06933394 | SYSKY-2024-749-02 | Ph 2 | recruiting | Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma |
| NCT02688140 TUD-APOLLO-064 | TUD-APOLLO-064 | Ph 3 | completed | Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia |
| NCT04793919 | ICC APL STUDY 02 2017-002383-40 | Ph 2 | recruiting | Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia |
| NCT04996030 | SY-2101-101 | Ph 1 | suspended | A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia |
| NCT06088030 | SYS-202309 | Ph 2 | recruiting | Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer |
| NCT03377725 | RuijinH mutant p53 MDS | Ph 3 | withdrawn | Decitabine and Arsenic Trioxide for Myelodysplastic Syndrome(MDS) |
| NCT00866918 results posted | AAML0631 NCI-2011-01904, CDR0000637184 | Ph 3 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia |
| NCT01014546 | I 154609 NCI-2009-01660, I 154609 | Ph 1 | terminated | Arsenic Trioxide With or Without Ascorbic Acid in Treating Patients With Myelofibrosis |
| NCT02190695 | 21357 | Ph 2 | completed | Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS |
| NCT01470248 results posted | IRB00050301 WCI1988-11, K23CA164015 | Ph 2 | completed | Study of Arsenic Trioxide in Small Cell Lung Cancer |
| NCT01397734 | 11-107 | Ph 1 | terminated | Arsenic Trioxide and Tyrosine Kinase Inhibitors for Chronic Myelogenous Leukemia (CML) |
| NCT01791894 ATO results posted | IRB-26400 SKIN0015 | Ph 1, Ph 2 | completed | Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma |
| NCT01835288 | IRB-26938 NCI-2013-00767, HEMAML0023 | Ph 2 | withdrawn | Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01428128 results posted | HSC20110177H | Ph 2 | completed | Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector |
| NCT01184053 NRR results posted | LCCC 0920 | Ph 2 | terminated | Trisenox® in Women With Metastatic Endometrial Cancer |
| NCT01738360 LUPSENIC | RC12_0021 2012-002259-40 | Ph 2 | terminated | Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC) |
| NCT00670150 | 9L-07-12 | Ph 2 | withdrawn | New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia |
| NCT00985530 | NU 08H9 NCI-2010-01852, STU00012159 | Ph 1 | terminated | Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia |
| NCT00671697 | 07-0916 / 201011797 | Ph 1 | completed | Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndromes and Acute Myeloid Leukemia |
| NCT00720564 | CDR0000600335 P30CA033572, CHNMC-07058 | Ph 1 | completed | Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRISENOX FDA Label Details
Indications & Usage
FDA Label (PDF)TRISENOX is indicated for the treatment of Acute Promyelocytic Leukemia.
WARNING: DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES AND ENCEPHALOPATHY INCLUDING WERNICKE'S Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with TRISENOX have experienced differentiation syndrome, which may be life-threatening or fatal. Signs and sy...
Track TRISENOX with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment