Drug · Small Molecule

Arsenic Trioxide

CI-DRUG-00000080Explore in graph →NCIt C1005 CHEMBL5483015 CIViC Approved

Regulatory

Approvals (18)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Acute Promyelocytic Leukemia	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.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	13	6	11	112	18	CA, EU, US	Sep 25, 2000	1997-11
Leukemia	Approved	Phase 4	9	4	10	59	5	EU, US	Sep 25, 2000	1997-11
Malignant Liver Neoplasm	Phase3	Phase 3	0	0	1	5	0	—	—	2001-03
Malignant Pancreatic Neoplasm	Phase2	Phase 2	1	0	0	2	0	—

Curated evidence

Clinical evidence (6)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–6 of 6 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
RARA Fusion1
Arsenic Trioxide + Tretinoin

Clinical trials

Trials with this intervention (113)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–113 of 113 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00513305	Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia	terminated	Phase 3	67	CephalonINDUSTRY	2	Aug 1, 2012	clinicaltrials
NCT00005595	Arsenic Trioxide in Treating Patients With Relapsed or Refractory Hodgkin's Disease	terminated	Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Thioredoxin reductase 1 inhibitor
Targets: 1 gene
UNII: S7V92P67HO
Aliases: Arseneous anhydride, Arseneous oxide, Arsenic (III) Oxide, Arsenic oxide, Arsenic oxide (as4o6), Arsenic Sesquioxide, Arsenic Trioxide, Arsenic trioxide accord, Arsenic trioxide medac, Arsenic trioxide mylan, Arsenicum album, Arsenous Acid, Arsenous Acid Anhydride, Arsenous Oxide, ATO, Diarsenic trioxide, NSC-759274, NSC-92859, Tetraarsenic hexaoxide, TEVA-ARSENIC TRIOXIDE, Trisenox, TRISENOX, White Arsenic

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (25)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XX27	ARSENIC TRIOXIDE
DIN (Health Canada)	02407833