arsenic trioxide
Small molecule targets NPM1, PML, RARA, TP53, TYMS via restoration
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute promyelocytic leukemia 1 milestone | |||||
| Filed | US (FDA) | TRISENOX | acute promyelocytic leukemia | 2017-09-12 | “the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of TRISENOX®” tevapharm.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | TRISENOX | — | 2018-01-12 | fda.gov ↗ |
| Approved | EU (EMA) | Trisenox | — | 2002-03-05 | europa.eu ↗ |
| Approved | US (FDA) | TRISENOX | — | 2000-09-25 | fda.gov ↗ |
Trials 134 · started per year
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2018-01-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia tevapharm.com ↗
This label expansion represents an important benefit as TRISENOX is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia. |
| 2017-09-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives FDA Priority Review for First Line Use of TRISENOX® (arsenic trioxide) in Patients with Low to Intermediate Risk Acute Promyelocytic Leukemia (APL) tevapharm.com ↗
The FDA has accepted the sNDA for priority review with regulatory action expected in the first quarter of 2018. |
| 2016-11-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Secures European Approval of Trisenox® for First Line Treatment of Low to Intermediate Risk Acute Promyelocytic Leukemia (APL) tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced it has obtained approval from the European Commission for an indication extension of Trisenox® (arsenic trioxide). |
| 2016-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Positive Opinion from European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to Extend Indication of Trisenox® for First Line Treatment of Low- to Intermediate Risk Acute Promyelocytic Leukemia (APL) tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an indication extension of Trisenox® (arsenic trioxide). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-01-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia tevapharm.com ↗ |
| 2017-09-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives FDA Priority Review for First Line Use of TRISENOX® (arsenic trioxide) in Patients with Low to Intermediate Risk Acute Promyelocytic Leukemia (APL) tevapharm.com ↗ |
| 2016-11-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Secures European Approval of Trisenox® for First Line Treatment of Low to Intermediate Risk Acute Promyelocytic Leukemia (APL) tevapharm.com ↗ |
| 2016-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Positive Opinion from European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to Extend Indication of Trisenox® for First Line Treatment of Low- to Intermediate Risk Acute Promyelocytic Leukemia (APL) tevapharm.com ↗ |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 150 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Arsenic Trioxide | “BACKGROUND: Arsenic Trioxide (ATO) is effective in about 20% of patients with myelodysplasia (MDS); its mechanisms of action have already been evaluated in vitro, but the in...” PMID 22964015 ↗ Sep 2012140“To investigate the safety of delivering arsenic trioxide (ATO) in combination with stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I...” NCT00185861 ↗ “After the run-in period, the patients were treated with interferon α-2b, arsenic trioxide for injection and venetoclax until the outcome of CR/PR/PD/ death/withdrawal/loss to...” NCT06450145 ↗ “However, arsenic trioxide (As2O3) has attracted worldwide interest in the field of oncology because of its substantial anticancer activity in patients with acute promyelocytic...” NCT02757040 ↗ “Arsenic tri-oxide (10 mg/10ml) will be diluted in 500 ml of Dextrose Saline (only glass bottles to be used) and infused intravenously over 3 - 4 hours once a day.” NCT00517712 ↗ “transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol” NCT02018757 ↗ “SDK Therapeutics is developing an oral formulation of arsenic trioxide (ATO) for the treatment of acute promyelocytic leukemia (APL).” NCT07296445 ↗ “As all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) are widely accepted in treating acute promyelocytic leukemia (APL)” PMID 33495363 ↗ Feb 2021 “Sham Comparator:Arsenic trioxide for 4 weeks (Days 0-28). Experimental:Arsenic trioxide for 3 weeks (Days 8-28).” NCT07503730 ↗ “Abiraterone, Arsenic Trioxide, Asparaginase Escherichia coli source” NCT02788201 ↗ “a) Arsenic trioxide: 0·15 mg/kg daily until CR” NCT04175587 ↗ |
| Known as | Arsenic trioxide for injection | “Arsenic trioxide for injection, 0.16 mg/kg (maximum single dose is 10 mg), daily IV drip, d1 to d14, once every 28 days, for six cycles of treatment or until one of the...” NCT04489706 ↗ |
| Known as | Arsenic trioxide for injection，producted by Beijing SL Pharmaceutical Co., Ltd. | “Arsenic trioxide for injection，producted by Beijing SL Pharmaceutical Co., Ltd.” NCT04489706 ↗ |
| Known as | Arsenol | “Oral arsenic trioxide (oral-ATO) (Arsenol ®) will be used in combination with ascorbic acid, and investigator choice of low-intensity therapy that comprised hypomethylating...” NCT06778187 ↗ |
| Known as | As(2)0(3) | “ascorbic acid (AA) enhances the activity of arsenic trioxide (As(2)0(3)) against drug-resistant MM in vitro” PMID 12473574 ↗ Dec 2002 |
| Known as | As2o3 | “Acute promyelocytic leukemia (APL) is an interesting model in cancer research, because it can respond to the differentiation/apoptosis induction therapy using all-trans...” PMID 11704843 ↗ Oct 20015“However, arsenic trioxide (As2O3) has attracted worldwide interest in the field of oncology because of its substantial anticancer activity in patients with acute promyelocytic...” NCT02757040 ↗ “We have formulated an oral preparation of As2O3 (oral-As2O3), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients.” NCT03624270 ↗ “Induction Arsenic Trioxide (As2O3=ATO), 0.15 mg/Kg IV over 2 hours daily starting on day 1.” NCT00482833 ↗ “arsenic trioxide (ATO and As(2)O(3))” PMID 18082257 ↗ Dec 2007 “Arsenic Trioxide (As2o3)” NCT00670150 ↗ |
| Known as | ATO | “In Acute promyelocytic leukemia treatment, a combination of retinoic acid (ATRA) and Arsenic trioxide (ATO) has an extremely high cure rate, with an overall five-year survival...” NCT04489706 ↗25“This study aimed to evaluate the efficacy and safety of a first-line combination of arsenic trioxide (ATO) and CS in adult patients with cGVHD requiring systemic therapy after...” PMID 35830931 ↗ Jul 2022 “To investigate the safety of delivering arsenic trioxide (ATO) in combination with stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I...” NCT00185861 ↗ “Arsenic trioxide (ATO) has demonstrated antitumor activity through mechanisms involving inhibition of the SHH signaling pathway and restoration of the function of selected...” NCT07856069 ↗ “All-trans retinoic acid (ATRA) and arsenic trioxide (ATO) combinations have produced excellent outcomes in patients with standard-risk acute promyelocytic leukemia (APL).” PMID 39584789 ↗ Nov 2024 “Arsenic Trioxide (ATO) is administered intravenously once daily, in combination with ATRA and venetoclax, during induction and consolidation therapy.” NCT07187505 ↗ “SDK Therapeutics is developing an oral formulation of arsenic trioxide (ATO) for the treatment of acute promyelocytic leukemia (APL).” NCT07296445 ↗ “As all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) are widely accepted in treating acute promyelocytic leukemia (APL)” PMID 33495363 ↗ Feb 2021 “induction therapy comprising tretinoin (ATRA) and arsenic trioxide (ATO) (along with idarubicin in patients with leukocytosis)” NCT00528450 ↗ “All-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) is a well-established treatment for patients with standard-risk APL” PMID 32330241 ↗ Apr 2020 “Arsenic trioxide (ATO) induces remission in 85% of adults with refractory acute promyelocytic leukemia (APL).” PMID 17959855 ↗ Oct 2007 |
| Known as | NSC #706363 | “A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia” NCT00006008 ↗ |
| Known as | oral-As2O3 | “We have formulated an oral preparation of As2O3 (oral-As2O3), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients.” NCT03624270 ↗ |
| Known as | oral-ATO | “Oral arsenic trioxide (oral-ATO) (Arsenol ®) will be used in combination with ascorbic acid, and investigator choice of low-intensity therapy that comprised hypomethylating...” NCT06778187 ↗1“The investigators have formulated an oral preparation of arsenic trioxide (oral-ATO)” NCT04687176 ↗ |
| Known as | QTX-2101 | “QTX-2101 (oral arsenic trioxide; ATO)” NCT07504458 ↗ |
| Known as | SDK001 | “Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state” NCT06882031 ↗ |
| Known as | Tricenox | “Drug: Arsenic Trioxide (Tricenox)” NCT00195104 ↗ |
| Known as | Trisenox | “Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)” NCT00225992 ↗3“Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 2 hours.” NCT00572065 ↗ “The second is arsenic trioxide (Trisenox).” NCT01404949 ↗ |
| Known as | TrisenoxTM Injection | “Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 1 to 4 hours” NCT00195104 ↗1“Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 2 hours.” NCT00572065 ↗ |
| Known as | Trisneox | “A Phase I/II Study to Determine Safety and Efficacy of Arsenic Trioxide (Trisneox™) in Combination With Imatinib (STI571, Gleevec™) in Patients With Chronic Myelogenous...” NCT00081133 ↗ |
| Action | Inhibit | “low dose arsenic (LDA)-induced transient p53 inhibition selectively protected normal tissues from chemotherapy-induced toxicity.” PMID 26440706 ↗ Sep 2015 |
| Modality | Small molecule | “pharmaceutical grade arsenic compound antineoplastic agent” NCT00582400 ↗ |
| Route | Intravenous | “arsenic trioxide IV over 1-4 hours” NCT00003395 ↗ |
| Target | TYMS | “Determine if arsenic trioxide down regulates the expression of thymidylate synthase” NCT00449137 ↗ |