Overview
Arsenic trioxide is a chemotherapeutic agent of idiopathic function used to treat leukemia that is unresponsive to first line agents. It is suspected that arsenic trisulfide induces cancer cells to undergo apoptosis. In general, arsenic is known to be a naturally toxic substance capable of eliciting a variety of dangerous adverse effects. The enzyme thioredoxin reductase has recently been identified as a target for arsenic trioxide.
Indication
For induction of remission and consolidation in patients with acute promyelocytic leukemia (APL), and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
Associated Conditions
- Acute Promyelocytic Leukemia
- Refractory Acute Promyelocytic Leukemia
- Relapsed Acute Promyelocytic Leukemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/18 | Phase 2 | Recruiting | |||
2024/11/01 | Phase 1 | Recruiting | |||
2023/10/18 | Phase 2 | Recruiting | Yang Li | ||
2022/08/11 | Phase 1 | Recruiting | Hospital Universitario Dr. Jose E. Gonzalez | ||
2022/03/28 | Phase 1 | UNKNOWN | |||
2021/08/09 | Phase 1 | Suspended | |||
2021/05/03 | Phase 2 | UNKNOWN | |||
2021/03/11 | Phase 2 | Recruiting | Associazione Italiana Ematologia Oncologia Pediatrica | ||
2021/01/05 | Phase 2 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2021/01/05 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Newton Laboratories, Inc. | 55714-2596 | ORAL | 15 [hp_X] in 1 mL | 5/21/2025 | |
| The Wellness Center for Research and Education, Inc. | 50181-0055 | ORAL | 6 [hp_X] in 1 mL | 5/28/2025 | |
| King Bio Inc. | 57955-6031 | ORAL | 10 [hp_X] in 59 mL | 5/23/2025 | |
| Newton Laboratories, Inc. | 55714-4862 | ORAL | 15 [hp_X] in 1 mL | 5/21/2025 | |
| Deseret Biologicals, Inc. | 43742-2218 | ORAL | 30 [hp_X] in 1 mL | 5/27/2025 | |
| Zydus Lifesciences Limited | 49315-005 | INTRAVENOUS | 1 mg in 1 mL | 11/5/2022 | |
| Newton Laboratories, Inc. | 55714-4748 | ORAL | 15 [hp_X] in 1 mL | 8/20/2025 | |
| Orbicular Pharmaceutical Technologies Private Limited | 81607-006 | INTRAVENOUS | 2 mg in 1 mL | 5/4/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1483 | INTRAVENOUS | 1 mg in 1 mL | 7/23/2021 | |
| Deseret Biologicals, Inc. | 43742-2265 | ORAL | 30 [hp_C] in 1 mL | 5/6/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/14/2019 | ||
Authorised | 3/5/2002 | ||
Withdrawn | 4/1/2020 | ||
Authorised | 9/17/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ASADIN INJECTION 1MG/ML | SIN16634P | INJECTION | 1mg/mL | 11/2/2022 | |
| ARSENIC TRIOXIDE-AFT CONCENTRATED SOLUTION FOR INJECTION FOR INFUSION 10MG/10ML | SIN16961P | INJECTION, SOLUTION, CONCENTRATE | 10mg/10ml | 2/22/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ARSENOL ORAL SOLUTION 1MG/ML | N/A | N/A | N/A | 6/28/2010 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Phenasen arsenic trioxide 10mg/mL injection | 320783 | Medicine | A | 7/25/2019 | |
| ARSENIC TRIOXIDE-AFT arsenic trioxide 10 mg/10 mL concentrated solution for injection ampoule | 337670 | Medicine | A | 9/14/2021 | |
| PHENASEN arsenic trioxide 10 mg/10 mL injection vial | 152760 | Medicine | A | 5/13/2009 | |
| Restless Legs Relief | 169216 | Medicine | A | 2/18/2010 | |
| Arsenic Trioxide Accord arsenic trioxide 10 mg/10 mL injection vial | 324603 | Medicine | A | 10/20/2020 | |
| ARSENIC TRIOXIDE LU arsenic trioxide 10 mg/10 mL injection vial | 321026 | Medicine | A | 6/11/2020 | |
| Hayfever Oral Spray | 351128 | Medicine | A | 12/8/2020 | |
| ARSENIC TRIOXIDE-AFT arsenic trioxide 12 mg/12 mL concentrated solution for injection vial | 384971 | Medicine | A | 2/27/2023 | |
| ARSENIC TRIOXIDE JUNO arsenic trioxide 10 mg/10 mL injection vial | 321027 | Medicine | A | 6/11/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ARSENIC TRIOXIDE SOLUTION FOR INJECTION | 02487357 | Solution - Intravenous | 10 MG / 10 ML | 1/31/2020 | |
| ARSENIC TRIOXIDE FOR INJECTION | marcan pharmaceuticals inc | 02554364 | Solution - Intravenous | 1 MG / ML | 5/27/2025 |
| ARSENIC TRIOXIDE FOR INJECTION | 02513420 | Solution - Intravenous | 10 MG / 10 ML | 3/11/2022 | |
| ARSENIC TRIOXIDE FOR INJECTION | Sterimax Inc | 02492768 | Solution - Intravenous | 1 MG / ML | 12/20/2019 |
| ARSENIC TRIOXIDE FOR INJECTION | eugia pharma inc. | 02541971 | Solution - Intravenous | 2 MG / ML | N/A |
| ARSENICUM ALBUM 3CH-30CH GLOBULES | boiron laboratoires | 00718777 | Tablet - Oral | 3 CH / CH | 12/31/1986 |
| TEVA-ARSENIC TRIOXIDE FOR INJECTION | teva canada limited | 02484358 | Solution - Intravenous | 10 MG / 10 ML | N/A |
| CORVOSAN | dr reckeweg canada | 00245755 | Liquid - Oral | 6 X / X | 12/31/1972 |
| TRISENOX | teva canada limited | 02480387 | Solution - Intravenous | 12 MG / 6 ML | 4/16/2020 |
| TRISENOX | teva canada limited | 02407833 | Solution - Intravenous | 10 MG / 10 ML | 9/9/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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