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Drug

Arsenic trioxide

Approved · EMA
Emerging researchLate-stage development
Also known as Acide Arsenieux, Arsenic Blanc, Arsenigen Saure, Arsenolite+8 more

Acide Arsenieux, Arsenic Blanc, Arsenigen Saure, Arsenolite, Arsenous oxide, Diarsenic oxide, Diarsenic trioxide, Trisenox, White arsenic, Arsenic oxide, Arsenic(III) oxide, arsénico trióxido.

RxNorm18330UNIIS7V92P67HO
1
Research papers
12
Active clinical trials
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase I Study With Dose-escalation and Expansion Evaluating the Safety and Efficacy of Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes Failing Erythropoiesis Stimulating Agents and Luspatercept (or Ineligible for the Latter)

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

Clinical trial2026-05-20Results expected Q4 2027 · ClinicalTrials.gov

Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia

Clinical trial2026-05-15Primary completion · ClinicalTrials.gov

A Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid

Clinical trial2026-02-18Results posted · ClinicalTrials.gov

A Phase 1 Study of ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-L1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.

Clinical trial2026-01-16Results expected Q1 2027 · ClinicalTrials.gov

LATITUDE - A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2-Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High-Risk, Acute Promyelocytic Leukemia

Clinical trial2025-12-29Results expected Q2 2027 · ClinicalTrials.gov

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

Clinical trial2025-10-09Primary completion · ClinicalTrials.gov

Market withdrawal: Arsenic trioxide Mylan (EMA)

Regulatory2025-04-14EMA

Approval: Arsenic trioxide medac (EMA)

Regulatory2020-09-17EMA

Approval: Arsenic trioxide Accord (EMA)

Regulatory2019-11-14EMA

Patient-derived xenografts faithfully replicated clinical outcome in a phase II co-clinical trial of arsenic trioxide in relapsed small cell lung cancer.

Research2016-05-03Journal of translational medicine

Approval: Trisenox (EMA)

Regulatory2002-03-05EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Arsenic trioxide
Aliases & brands
Acide ArsenieuxArsenic BlancArsenigen SaureArsenoliteArsenous oxideDiarsenic oxideDiarsenic trioxideTrisenoxWhite arsenicArsenic oxideArsenic(III) oxidearsénico trióxido
RxNorm CUI
18330
UNII
S7V92P67HO
Regulatory jurisdictions
ema

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2002-03-05
Latest approval
2020-09-17
Authorities
EMA
Total events
4
emaEuropean Medicines Agency· 4 events
2025-04-14Market withdrawalMarket
Market withdrawal: Arsenic trioxide Mylan (EMA)
Indication: Arsenic trioxide Mylan is indicated for induction of remission, and consolidation in adult patients with:- Newly diagnosed low to intermediate risk acute promyelocytic leukaemia… Show full indication

Arsenic trioxide Mylan is indicated for induction of remission, and consolidation in adult patients with:- Newly diagnosed low to intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all trans retinoic acid (ATRA)- Relapsed/refractory acute promyelocytic leukaemia (APL) (Previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (PML/RAR alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.

Evidence ↗
2020-09-17Approval
Approval: Arsenic trioxide medac (EMA)
Indication: Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia… Show full indication

Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 10³/?l) in combination with all-trans-retinoic acid (ATRA) Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR?) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Evidence ↗
2019-11-14Approval
Approval: Arsenic trioxide Accord (EMA)
Indication: Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL)… Show full indication

Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all-trans-retinoic acid (ATRA) Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

115 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
115
registered trials across all phases
LATEST COMPLETION 2025
12
Active studies
9
Recruiting
15
Late-stage (III+)
54
Completed
49
Discontinued
PHASE DISTRIBUTIONn = 115
Early Phase 12Phase 125Phase 1 / 213Phase 260Phase 2 / 32Phase 39Phase 42Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

APL-R2007: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

CompletedPH IVPETHEMA Foundationn=602014

Treatment of Relapsed Acute Promyelocytic Leukemia With Arsenic Trioxide (Phase IV Study)

Unknown statusPH IVGerman AML Cooperative Groupn=302010

A Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid

Active, not recruitingPH IIIChildren's Oncology Groupn=1582029

LATITUDE - A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2-Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High-Risk, Acute Promyelocytic Leukemia

Not yet recruitingPH IIISDK Therapeutics, Inc.n=1202029

A Randomized Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA and Idarubicin Versus Standard ATRA and Anthracyclines-based Chemotherapy (AIDA Regimen) for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

CompletedPH IIITechnische Universität Dresdenn=1332025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA and Idarubicin Versus Standard ATRA and Anthracyclines-based Chemotherapy (AIDA Regimen) for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

CompletedPH IIITechnische Universität Dresdenn=1332025

Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation

CompletedPH IIIChildren's Oncology Groupn=1062022

Leukemia SPORE Phase II Randomized Study of Decitabine Versus Decitabine and Carboplatin Versus Decitabine and Arsenic in Relapsed, Refractory, and Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

CompletedPH IIFox Chase Cancer Centern=922020

A Randomised Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA Versus Standard ATRA and Anthracycline-Based Chemotherapy (AIDA Regimen) for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia

CompletedPH IIIGruppo Italiano Malattie EMatologiche dell'Adulton=2762019

S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

CompletedPH IISWOG Cancer Research Networkn=782018

Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Idarubicin

CompletedPH IIM.D. Anderson Cancer Centern=782016

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes1
Xenograft Model Antitumor Assays1
Journals, researchers & institutions
Top journals
  • Journal of translational medicine1
Leading researchers
  • Bechara R1
  • Chen Z1
  • Deng X1
  • Khuri FR1
  • Kim HS1
  • Owonikoko TK1
  • Pakkala S1
  • Pillai R1
Leading institutions
free-text, unnormalised
  • Emory University School of Medicine1
  • Rollins School of Public Health and Biostatistics Shared Resource1
  • Winship Cancer Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.