CDEK
← All drugs Report issue

arsenic trioxide

Trade name: trisenox

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Sep 25, 2000

Arsenic trioxide (ATO) is used to treat acute promyelocytic leukemia in people who have not been helped by other types of chemotherapy or whose condition has improved but then worsened following treatment with other types of chemotherapy. Arsenic trioxide acts through activation of Jun N-terminal kinase (JNK), activator protein-1, and inhibition of dual-specificity phosphatases. Although the exact mechanisms under which ATO exerts its therapeutic effect in acute promyelocytic leukemia cancer cells are not well elucidated. It was shown that apoptotic mechanisms involved the induction of phosphatidylserine externalization, caspase-3 activation, and nucleosomal DNA fragmentation. Adverse reactions described are leukocytosis, nausea, vomiting, diarrhea, and abdominal pain, fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, and dizziness. — NCATS

Clinical trial activity

134 trials · 115 clinical orgs · 19 marketing orgs

Phase 1
42
Phase 2
95
Phase 3
13
Phase 4
4

Earliest trial started Nov 1, 1997 (NCT00003885)

Timeline

1990s

  1. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

  3. Mar 3, 1998

    Orphan Drug Designation

  4. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Sep 25, 2000

    CTI BioPharma — Earliest FDA Approval

  2. Sep 25, 2000

    Cephalon — NDA Secondary Org

  3. Sep 25, 2000

    CTI BioPharma — NDA Organization

  4. Oct 3, 2008

    Teva — Marketing Organization

2010s

  1. Aug 31, 2018

    Fresenius — Marketing Organization

  2. Nov 13, 2018

    Amring Pharmaceticals — Marketing Organization

  3. Nov 13, 2018

    Zydus Discovery DMCC — Marketing Organization

  4. Nov 15, 2018

    Ingenus Pharmaceuticals — Marketing Organization

  5. Nov 15, 2018

    Nexus Pharmaceuticals — Marketing Organization

  6. Nov 15, 2018

    Novast Labs — Marketing Organization

  7. May 6, 2019

    STI Pharma, LLC — Marketing Organization

  8. May 6, 2019

    PENN LIFE — Marketing Organization

2020s

  1. Jan 25, 2021

    Amneal Pharmaceuticals — Marketing Organization

  2. Jul 19, 2021

    Gland Pharma Ltd — Marketing Organization

  3. Oct 7, 2021

    Fosun — Marketing Organization

  4. Oct 15, 2021

    Eugia Pharma — Marketing Organization

  5. Dec 2, 2021

    Sandoz — Marketing Organization

  6. Dec 2, 2021

    Novartis — Marketing Organization

  7. Apr 20, 2023

    ORBICULAR — Marketing Organization

  8. Apr 20, 2023

    MSN Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackSep 25, 2000

Chemistry & pharmacology

Loading structure…

SMILES

[As+3]
Mol. weight
74.9216 g/mol
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • acide arsenieux
  • anhydride arsenieux
  • arsenic blanc
  • arsenic(iii) oxide
  • arsenic(iii) oxide
  • arsenic(iii) oxide
  • arsenic oxide
  • arsenic oxide
  • arsenic oxide (as2o3)
  • arsenic oxide (as4o6)
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenic trioxide
  • arsenigen saure
  • arsenious oxide
  • arsenious trioxide
  • arsenolite
  • arsenolite
  • arsenolite
  • arsenous anhydride
  • arsenous oxide
  • arsenous oxide anhydride
  • arsenous oxide anhydride
  • as2o3
  • as2o3
  • as4o6
  • diarsenic oxide
  • diarsenic trioxide
  • diarsenic trioxide
  • diarsenic trioxide
  • naonobin
  • tetra-arsenic hexaoxide
  • tetraarsenic hexaoxide
  • tetra-arsenic oxide
  • tetraarsenic oxide
  • trisenox
  • trisenox
  • trisenox
  • trisenox
  • trisenox
  • trisenox
  • trisenox
  • trixenox
  • white arsenic
  • white arsenic

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07296445Phase 3Jan 31, 2026SDK Therapeutics, Inc.
NCT07187505N/AJul 1, 2025Anhui Medical University
NCT06933394Phase 2May 1, 2025Sun Yat-Sen University
NCT06882031Phase 1Mar 11, 2025SDK Therapeutics, Inc., The University of Hong Kong
NCT06778187Phase 2Feb 28, 2025The University of Hong Kong
NCT06670222Phase 1Feb 28, 2025Groupe Francophone des Myelodysplasies
NCT06678048Phase 2Nov 6, 2024Sun Yat-Sen University
NCT06088030Phase 2Dec 13, 2023Jiao Tong University, Sun Yat-Sen University
NCT05721872Phase 1/Phase 2 (Phase 2)Feb 15, 2023Nazarbayev University Medical Center
NCT05497310Phase 1/Phase 2 (Phase 2)Jul 1, 2022Universidad Autonoma de Nuevo Leon
NCT04996030Phase 1Sep 17, 2021Syros Pharmaceuticals
NCT04869475Phase 2Apr 20, 2021Jiao Tong University
NCT04687176Phase 2Jan 1, 2021The University of Hong Kong
NCT04695223Phase 2Jan 1, 2021Second Military Medical University
NCT04689815Phase 2Jan 1, 2021The University of Hong Kong
NCT04518501Phase 1/Phase 2 (Phase 2)Jul 1, 2020Georgia Institute of Technology, Zhejiang University
NCT04489706N/AJun 28, 2020Jiao Tong University
NCT04793919Phase 2Oct 9, 2019Associazione Italiana Ematologia Oncologia Pediatrica, Bambino Gesù Hospital and Research Institute
NCT03980665Phase 1Apr 1, 2019Guangzhou Medical University, Guangzhou University
NCT05297123Phase 1Feb 3, 2019Jiao Tong University
Showing 20 of 134 trials
Page 1 / 7

Organizations

Research & Development (115)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government50941998
Cornell UniversityAcademic/Hospital131321998
CephalonFor profit12132003
Jiao Tong UniversityAcademic/Hospital10852012
University of Texas at HoustonAcademic/Hospital10722000
CTI BioPharmaFor profit9322001
Sun Yat-Sen UniversityAcademic/Hospital6422011
Northwestern UniversityAcademic/Hospital5422000
TevaFor profit5032011
The University of Hong KongAcademic/Hospital5422018
Stanford UniversityAcademic/Hospital4432003
City of Hope National Medical CenterAcademic/Hospital3122005
Oregon Health and Science UniversityAcademic/Hospital3212002
University of MiamiAcademic/Hospital3322000
University of RochesterAcademic/Hospital3212004
University of Southern CaliforniaAcademic/Hospital3212002
University of Texas, GalvestonAcademic/Hospital3312002
Washington University in St. LouisAcademic/Hospital3321998
Cancer and Leukemia Group B (CALGB)Academic/Hospital2021999
Chinese Academy of Medical SciencesAcademic/Hospital2122014
115 organizations
Page 1 / 6

Marketing (22)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGJan 25, 2021
Amring PharmaceticalsFor profitMKTGNov 13, 2018
CTI BioPharmaFor profitNDASep 25, 2000
CephalonFor profitNDA2Sep 25, 2000
Eugia PharmaFor profitMKTGOct 15, 2021
FosunFor profitMKTGOct 7, 2021
FreseniusFor profitMKTGAug 31, 2018
Gland Pharma LtdFor profitMKTGJul 19, 2021
Gland Pharma LtdFor profitSYNOct 7, 2021
Ingenus PharmaceuticalsFor profitMKTGNov 15, 2018
MSN LaboratoriesFor profitMKTGApr 20, 2023
Nexus PharmaceuticalsFor profitMKTGNov 15, 2018
Nexus PharmaceuticalsFor profitSYNNov 15, 2018
NovartisFor profitMKTGDec 2, 2021
Novast LabsFor profitMKTGNov 15, 2018
ORBICULARFor profitMKTGApr 20, 2023
PENN LIFEFor profitMKTGMay 6, 2019
STI Pharma, LLCFor profitMKTGMay 6, 2019
SandozFor profitMKTGDec 2, 2021
SandozFor profitSYNDec 2, 2021
TevaFor profitMKTGOct 3, 2008
Zydus Discovery DMCCFor profitMKTGNov 13, 2018