doxorubicin

Trade name: Doxil

Small moleculeapproved

Approved

Aug 7, 1974

Doxorubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Doxorubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Doxorubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. Doxorubicin is used to produce regression in disseminated neoplastic conditions like acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer. — NCATS

Clinical trial activity

2,187 trials · 994 clinical orgs · 30 marketing orgs

Phase 1
447
Phase 2
1726
Phase 3
582
Phase 4
49

Earliest trial started Sep 1, 1978 (NCT00001165)

Timeline

1970s

  1. Aug 7, 1974

    Earliest FDA Approval

  2. Aug 7, 1974

    Pfizer — Marketing Organization

  3. Aug 7, 1974

    Pharmacia & Upjohn — NDA Secondary Org

  4. Aug 7, 1974

    Pfizer — NDA Secondary Org

  5. Jan 1, 1978

    Earliest Phase 2 Sponsor(trial)

1980s

  1. Jan 1, 1986

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1988

    Earliest Phase 3 Sponsor(trial)

  3. Mar 17, 1989

    West-Ward Pharmaceutical — Marketing Organization

  4. Mar 17, 1989

    Hikma — Marketing Organization

  5. Apr 13, 1989

    Bristol-Myers Squibb — Marketing Organization

1990s

  1. May 21, 1990

    Pharmachemie Bv — Marketing Organization

  2. Jul 28, 1995

    Teva — Marketing Organization

  3. Oct 26, 1995

    Fresenius — Marketing Organization

  4. Nov 17, 1995

    Johnson and Johnson — NDA Secondary Org

  5. Nov 17, 1995

    Baxalta — Marketing Organization

  6. Nov 17, 1995

    Baxalta — NDA Secondary Org

2010s

  1. Oct 28, 2011

    Mylan — Marketing Organization

  2. Feb 14, 2012

    PHARMOBEDIENT — Marketing Organization

  3. Jul 18, 2012

    Sandoz — Marketing Organization

  4. Jul 18, 2012

    Healthcare Discoveries Inc. — Marketing Organization

  5. Nov 8, 2012

    Alvogen — Marketing Organization

  6. Nov 8, 2012

    Almaject — Marketing Organization

  7. Feb 4, 2013

    Sun Pharmaceuticals — Marketing Organization

  8. Mar 18, 2013

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  9. Jun 27, 2014

    Actavis — Marketing Organization

  10. Feb 17, 2017

    Amneal Pharmaceuticals — Marketing Organization

  11. May 15, 2017

    Dr. Reddy's Laboratories — Marketing Organization

  12. Aug 11, 2017

    Gland Pharma Ltd — Marketing Organization

  13. May 13, 2019

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

2020s

  1. Sep 10, 2020

    Zydus Discovery DMCC — Marketing Organization

  2. Oct 12, 2021

    Ayana Pharma Ltd., — Marketing Organization

  3. Oct 19, 2022

    Capstone Therapeutics — Marketing Organization

  4. Jul 16, 2024

    Lupin — Marketing Organization

  5. Jun 27, 2025

    Alembic — Marketing Organization

  6. Feb 3, 2026

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAug 7, 1974

Chemistry & pharmacology

Loading structure…

SMILES

COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)C[C@@](O)(C(=O)CO)C[C@@H]3O[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1
Mol. weight
543.53 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 14-hydroxydaunomycin
  • 14-hydroxydaunomycin
  • 14-hydroxydaunorubicine
  • 14-hydroxydaunorubicine
  • (1s,3s)-3-glycoloyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranoside
  • (1s,3s)-3-glycoloyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranoside
  • 2b3-101
  • 2b3-101
  • (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
  • (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
  • adriamycin
  • adriamycin
  • adriamycin
  • adriamycin
  • adriamycin
  • adriamycin pfs
  • adriamycin pfs
  • adriamycin rdf
  • adriamycin rdf
  • adriblastin
  • adriblastin
  • adriblastina
  • adriblastina
  • ati-0918
  • caelyx
  • caelyx
  • caelyx
  • caelyx
  • doxil
  • doxil
  • doxil
  • doxil
  • doxirubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicin
  • doxorubicine
  • doxorubicine
  • doxorubicine
  • doxorubicin hcl
  • doxorubicin hcl
  • doxorubicin hcl
  • doxorubicin hydrochloride
  • doxorubicin hydrochloride
  • doxorubicin hydrochloride
  • doxorubicin hydrochloride
  • doxorubicin hydrochloride
  • doxorubicin hydrochloride
  • doxorubicin hydrochloride liposome
  • doxorubicin liposomal
  • doxorubicin pegylated
  • doxorubicinum
  • doxorubicinum
  • dox-sl
  • glutathione pegylated liposomal doxorubicin
  • hydroxydaunomycin
  • hydroxydaunorubicin
  • hydroxydaunorubicin
  • hydroxydaunorubicin
  • hydroxydaunorubicin
  • hydroxydaunorubicin
  • hydroxydaunorubicin hcl
  • hydroxydaunorubicin hydrochloride
  • lipodox
  • liposomal doxorubicin
  • liposomal doxorubicin
  • liposomal doxorubicin
  • liposomal doxorubicin
  • liposomal pegylated doxorubicin
  • myocet
  • myocet
  • myocet
  • pegylated doxorubicin
  • pegylated liposomal doxorubicin
  • pegylated liposomal doxorubicin
  • rubex
  • rubex
  • rubidox
  • tlc d-99
  • tlc d-99

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07220187Phase 3May 2, 2026National Cancer Institute (NCI), SWOG Cancer Research Network
NCT07224100Phase 2May 1, 2026Takeda, University of Washington
NCT07227584Phase 2Apr 30, 2026Harvard University
NCT07278856Phase 1Apr 27, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07300475Phase 1Mar 31, 2026Washington University in St. Louis
NCT07072585Phase 2/Phase 3 (Phase 3)Mar 30, 2026National Cancer Institute (NCI)
NCT07286331Phase 3Mar 5, 2026European Network for Gynaecological Oncological Trial, GlaxoSmithKline, GOG Foundation, Inc.
NCT07286266Phase 3Mar 3, 2026European Network for Gynaecological Oncological Trial, GlaxoSmithKline, GOG Foundation, Inc.
NCT07302919Phase 2/Phase 3 (Phase 3)Jan 15, 2026University of Basel
NCT07231250Phase 2Jan 15, 2026Sun Yat-Sen University
NCT07097363Phase 2Jan 1, 2026AbbVie, University of Washington
NCT07125183Phase 2Dec 31, 2025Cancer League of Colorado, Inc, University of Colorado, Denver
NCT07243626Phase 2Dec 30, 2025Zhejiang University
NCT07139951Phase 2Dec 11, 2025Mayo Clinic
NCT07078604Phase 2Dec 1, 2025Kuni Foundation, University of Washington
NCT07076186Phase 2Dec 1, 2025University of Texas at Houston
NCT07218809Phase 3Nov 28, 2025AstraZeneca, European Network for Gynaecological Oncological Trial, GOG Foundation, Inc.
NCT07215585Phase 3Nov 2, 2025AstraZeneca, Peter MacCallum Cancer Centre
NCT07102940Phase 2Nov 1, 2025George Washington University, Immutep S.A.
NCT07194044Phase 1Oct 31, 2025National Pediatric Cancer Foundation, University of South Florida
Showing 20 of 2,187 trials
Page 1 / 110

Organizations

Research & Development (994)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government53123641986
University of Texas at HoustonAcademic/Hospital988941993
RocheFor profit593651999
Cornell UniversityAcademic/Hospital584441990
Harvard UniversityAcademic/Hospital554441994
Sun Yat-Sen UniversityAcademic/Hospital554242006
MerckFor profit532652003
Southwest Oncology GroupAcademic/Hospital483021989
Fudan UniversityAcademic/Hospital382742000
GenentechFor profit38431998
University of WashingtonAcademic/Hospital372541992
Eastern Cooperative Oncology GroupAcademic/Hospital351421989
European Organisation for Research and Treatment of CancerAcademic/Hospital353031989
Jiao Tong UniversityAcademic/Hospital352542008
Johnson and JohnsonFor profit332331997
Mayo ClinicAcademic/Hospital291541989
AmgenFor profit28641999
Chinese Academy of Medical SciencesAcademic/Hospital281452008
Millennium PharmaceuticalsFor profit28732004
CelgeneFor profit26631998
994 organizations
Page 1 / 50

Marketing (38)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJun 27, 2014
AlembicFor profitMKTGJun 27, 2025
AlmajectFor profitMKTGNov 8, 2012
AlvogenFor profitMKTGNov 8, 2012
Amneal PharmaceuticalsFor profitMKTGFeb 17, 2017
Amneal PharmaceuticalsFor profitSYNFeb 17, 2017
Ayana Pharma Ltd.,For profitMKTGOct 12, 2021
BaxaltaFor profitMKTGNov 17, 1995
BaxaltaFor profitNDA2Nov 17, 1995
Bristol-Myers SquibbFor profitMKTGApr 13, 1989
Capstone TherapeuticsFor profitMKTGOct 19, 2022
Dr. Reddy's LaboratoriesFor profitSYNMay 15, 2017
Dr. Reddy's LaboratoriesFor profitMKTGMay 15, 2017
Farmitalia Carlo ErbaFor profitNDA
FreseniusFor profitMKTGOct 26, 1995
Gland Pharma LtdFor profitMKTGAug 11, 2017
Gland Pharma LtdFor profitSYNAug 11, 2017
Healthcare Discoveries Inc.For profitMKTGJul 18, 2012
HikmaFor profitMKTGMar 17, 1989
Johnson and JohnsonFor profitNDA2Nov 17, 1995
LupinFor profitMKTGJul 16, 2024
MylanFor profitMKTGOct 28, 2011
PHARMOBEDIENTFor profitMKTGFeb 14, 2012
PfizerFor profitMKTGAug 7, 1974
PfizerFor profitNDA2Aug 7, 1974
Pharmachemie BvFor profitMKTGMay 21, 1990
Pharmacia & UpjohnFor profitNDA2Aug 7, 1974
Qilu Pharmaceutical Co., Ltd.For profitMKTGFeb 3, 2026
Sagent Pharmaceuticals, Inc.For profitMKTGMar 18, 2013
SandozFor profitMKTGJul 18, 2012
Sun PharmaceuticalsFor profitSYNFeb 4, 2013
Sun PharmaceuticalsFor profitMKTGFeb 4, 2013
Sun PharmaceuticalsFor profitSYNFeb 15, 2012
TevaFor profitMKTGJul 28, 1995
West-Ward PharmaceuticalFor profitMKTGMar 17, 1989
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGMay 13, 2019
Zydus Discovery DMCCFor profitMKTGSep 10, 2020
Zydus Discovery DMCCFor profitSYNSep 10, 2020