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.
Background
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 | |||
2025/02/21 | Phase 1 | Not yet 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 | |
| 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 | |
| Cephalon, LLC | 63459-601 | INTRAVENOUS | 2 mg in 1 mL | 6/30/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/5/2002 | ||
Authorised | 9/17/2020 | ||
Authorised | 11/14/2019 | ||
Authorised | 11/14/2019 | ||
Withdrawn | 4/1/2020 | ||
Authorised | 11/14/2019 | ||
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 |
|---|---|---|---|---|---|
| Arsenic Trioxide for Injection | 国药准字H20080665 | 化学药品 | 注射剂（冻干粉针剂） | 10/25/2023 | |
| Arsenic Trioxide for Injection | 国药准字H20080664 | 化学药品 | 注射剂（冻干粉针剂） | 10/25/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ARSENOL ORAL SOLUTION 1MG/ML | N/A | unicorn laboratories o/b american unicorn laboratories limited | 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 |