Drug · Small Molecule

Doxorubicin

CI-DRUG-00000195Explore in graph →NCIt C456 CHEMBL53463 CIViC Approved

Regulatory

Approvals (41)

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

health-canada-dpdRegulatory41 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as TARO-DOXORUBICIN LIPOSOMAL (DIN 02493020) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 19, 2020	health-canada-dpd

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	287	125	372	1,353	41	CA, EU, US	Dec 23, 1987	1988-03
Non-Hodgkin Lymphoma	Approved	Phase 4	88	34	55	233	1	US	Nov 17, 1995	May 8, 1993
Malignant Breast Neoplasm	Approved	Phase 4	37	16	65	249	2	EU, US	Dec 23, 1987	1989-05
Malignant Ovarian Neoplasm	Approved	Phase 3	18	10	17	68

Curated evidence

Clinical evidence (41)

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

civicCuratedShowing 1–41 of 41 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
NT5C2 R238W1
Cytarabine + Doxorubicin

Clinical trials

Trials with this intervention (1,373)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 1,373 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
NCT00092222	Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity	active not recruiting	Phase 2	75	National Cancer Institute (NCI)NIH	1	Sep 28, 2026	clinicaltrials
NCT05600686	Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma

Molecule

Record

Kind: Small Molecule
Mechanism: DNA topoisomerase II alpha inhibitor; DNA inhibitor
Targets: 1 gene
UNII: 82F2G7BL4E
Aliases: 14-Hydroxydaunomycin, (8S-cis)-10-[(3-Amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroacetyl)-1-methoxy-5,12-naphthacenedione, (8S-cis)-10-[(3-Amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione, Adriablastin, ADRIAMYCIN PFS, ADRIAMYCIN RDF, Adriblastina, CAELYX, Caelyx pegylated liposomal, Celdoxome pegylated liposomal, DOXIL, Doxorubicin, Doxorubicina, Doxorubicine, DOXORUBICIN HCL FOR INJ. U.S.P., Doxorubicin Hydrochloride, DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE LIPOSOME, Epirubicin hydrochloride impurity, doxorubicin-, Hydroxydaunomycin, Hydroxydaunorubicin, Hydroxyldaunorubicin, Hydroxyl Daunorubicin, MYOCET, Myocet liposomal, NSC-123127, NSC-759155, PEGYLATED LIPOSOMAL DOXORUBICIN HYDROCHLORIDE, TARO-DOXORUBICIN LIPOSOMAL, Valrubicin impurity, doxorubicin … (+1)

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (56)

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

System	Code	Label
ATC (WHO)	L01DB

TP53 Mutation3
Cisplatin + Doxorubicin + EtoposideCombination	Gastric CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	1	accepted	EID2820 In a study of 25 patients with advanced gastric cancer, mutations in TP53 were identified in 32% of primary tumors. TP53 mutations were associated with an improved response to preoperative treatment o… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
Doxorubicin	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	4	accepted	EID851 In this preclinical study, MMTV-Wnt1 mammary tumors with mutant TP53 showed a better clinical response to chemotherapy (doxorubicin) than TP53 wild-type tumors. This was mediated by wild-type TP53-ind… (full text at CIViC) PMID 22698404 · Jackson et al., 2012 · Open in CIViC	civic
Doxorubicin + EprenetapoptCombination	Malignant Ovarian Neoplasm	Predictive	D	Supports Sensitivity Response	4	submitted	EID12011 This study examined the combined effects of APR-246 and doxorubicin in doxorubicin-resistant ovarian cancer cell lines. It revealed a decrease in IC50 value for doxorubicin from 0.95±0.11 μM to 0.12±0… (full text at CIViC) PMID 26086967 · Mohell et al., 2015 · Open in CIViC	civic

ZEB1 Expression2
Cytarabine + Doxorubicin + GemcitabineSubstitutes	Mantle Cell Lymphoma	Predictive	D	Supports Resistance	2	accepted	EID899 Downregulation of ZEB1 expression in mantle cell lymphoma cell lines and mouse xenografts led to enhanced sensitivity towards treatment with doxorubicin, cytarabin and gemcitabine. PMID 24013721 · Sánchez-Tilló et al., 2014 · Open in CIViC	civic
Doxorubicin + SalinomycinCombination	Mantle Cell Lymphoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID900 Downregulation of ZEB1 expression in mantle cell lymphoma cell lines and mouse xenografts led to enhanced sensitivity towards treatment with doxorubicin, cytarabin and gemcitabine. the combination of … (full text at CIViC) PMID 24013721 · Sánchez-Tilló et al., 2014 · Open in CIViC	civic