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Drug

Doxorubicin

Approved · EMA
Emerging researchLate-stage developmentCooling momentum
Also known as 14-hydroxydaunorubicine, Caelyx, DOXOrubicin Liposomal, Doxil+11 more

14-hydroxydaunorubicine, Caelyx, DOXOrubicin Liposomal, Doxil, Doxorubicin nanoparticles, Lipodox, Lipodox 50, 14-hydroxydaunomycin, Adriamycin, Hydroxyl daunorubicin, Hydroxyldaunorubicin, Doxorubicina, Doxorubicine, DOXOrubicin Hydrochloride, Doxorubicinum.

12
Research papers
66
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study

Clinical trial2026-07-24Status changed to Active, not recruiting · ClinicalTrials.gov

Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.

Research2021-12-14The New England journal of medicine

Estimating the global burden of Epstein-Barr virus-related cancers.

Research2021-10-27Journal of cancer research and clinical oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Doxorubicin
Aliases & brands
14-hydroxydaunorubicineCaelyxDOXOrubicin LiposomalDoxilDoxorubicin nanoparticlesLipodoxLipodox 5014-hydroxydaunomycinAdriamycinHydroxyl daunorubicinHydroxyldaunorubicinDoxorubicinaDoxorubicineDOXOrubicin HydrochlorideDoxorubicinum
RxNorm CUI
3639
ChEMBL ID
CHEMBL53463
ATC codes
L01DB01
UNII
80168379AG
Regulatory jurisdictions
ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2000-07-13
Latest approval
2022-05-31
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2025-09-22Market withdrawalMarket
Market withdrawal: Celdoxome pegylated liposomal (EMA)
Indication: Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment ofShow full indication

Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Evidence ↗
2022-05-31Approval
Approval: Zolsketil pegylated liposomal (EMA)
Indication: Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults: • breast cancer that has spread to other parts of the body in patients at riskShow full indication

Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults: • breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil pegylated liposomal is used on its own for this disease; • advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working; • multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine); • Kaposi’s sarcoma in patients with AIDS who have a very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.

Evidence ↗
2000-07-13Approval
Approval: Myocet liposomal (previously Myocet) (EMA)

Indication: Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

199 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
199
registered trials across all phases
LATEST COMPLETION 2026
66
Active studies
40
Recruiting
50
Late-stage (III+)
81
Completed
52
Discontinued
PHASE DISTRIBUTIONn = 199
Early Phase 11Phase 127Phase 1 / 225Phase 296Phase 2 / 31Phase 341Phase 43Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

12 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20012024
Most influential
Recent papers
Major research themes8
Cardiotoxicity1Cystectomy1Doxorubicin1Erb-b2 Receptor Tyrosine Kinases1Extracellular Vesicles1Proteomics1Semiconductors1STAT3 Transcription Factor1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine3
  • Accounts of chemical research1
  • ACS nano1
  • Blood1
  • Cancer1
  • Cardiovascular research1
Leading researchers
  • Bryant J2
  • Burke JM2
  • Swain SM2
  • Wolmark N2
  • Abrisqueta P1
  • Anderson RA1
  • Bergua-Burgués JM1
  • Boen H1
Leading institutions
free-text, unnormalised
  • Antwerp University Hospital (UZA)1
  • Australian Institute of Tropical Health and Medicine1
  • Blokhin Cancer Research Center1
  • Cancer Therapy and Research Center1
  • Cardiovascular Center OLV Hospital Aalst1
  • Center for Molecular and Vascular Biology1

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 15 of the same disease areas as Doxorubicin in the shared literature.

15 shared diseases5 shared papers

Studied across 12 of the same disease areas as Doxorubicin in the shared literature.

12 shared diseases2 shared papers

Studied across 9 of the same disease areas as Doxorubicin in the shared literature.

9 shared diseases2 shared papers

Studied across 9 of the same disease areas as Doxorubicin in the shared literature.

9 shared diseases2 shared papers

Studied across 9 of the same disease areas as Doxorubicin in the shared literature.

9 shared diseases1 shared paper

Studied across 9 of the same disease areas as Doxorubicin in the shared literature.

9 shared diseases1 shared paper

Studied across 7 of the same disease areas as Doxorubicin in the shared literature.

7 shared diseases2 shared papers

Studied across 8 of the same disease areas as Doxorubicin in the shared literature.

8 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.