TheraRadar
Data updated: Jul 17, 2026

ARSENIC TRIOXIDE · Fresenius Kabi

Generic · see TRISENOX
Oncology Approved 2000-09-25

ARSENIC TRIOXIDE is FDA-approved to treat 1 condition (same as TRISENOX).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
9
Indications
--
Phase 3 Trials
25
Years on Market

Details

Status
Prescription
First Approved
2000-09-25
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Fresenius Kabi NEXUS J MOLNER GLAND ZYDUS PHARMS MSN INGENUS PHARMS LLC PENN LIFE AMNEAL EUGIA PHARMA Novartis Teva
Active Ingredient: ARSENIC TRIOXIDE

ARSENIC TRIOXIDE Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
28 FDA actions from 2018 to 2026
Jun 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling
Jul 2024 SUPPL
Label · Labeling

What ARSENIC TRIOXIDE Treats

1 indications

ARSENIC TRIOXIDE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acute Promyelocytic Leukemia

Same approved indications as TRISENOX (same active ingredient).

Source: FDA Label

Fresenius Kabi's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

OMEGAVEN
2018
FISH OIL TRIGLYCERIDES
3 designations
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

ARSENIC TRIOXIDE FDA Label Details

Indications & Usage

ARSENIC TRIOXIDE is FDA-approved to treat 1 condition — same approved indications as TRISENOX.

Looking for the branded version?

TRISENOX

Full clinical data, patents, trials, and competitive landscape for arsenic trioxide.

See TRISENOX

Data Sources

FDA Approval: ANDA208231 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.