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bleomycin

Trade name: blenoxane

Small moleculeapproved

Approved

Jul 31, 1973

Bleomycin is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. Bleomycin has antitumor activity. Bleomycin selectively inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed. Bleomycin has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, TNFa, and IL-2. The antibiotic antitumor drugs are cell cycle-nonspecific except for Bleomycin (which has major effects in G2 and M phases). — NCATS

Clinical trial activity

191 trials · 193 clinical orgs · 11 marketing orgs

Phase 1
19
Phase 2
145
Phase 3
72
Phase 4
9

Earliest trial started Apr 1, 1989 (NCT00276718)

Timeline

1970s

  1. Jul 31, 1973

    Bristol-Myers — Earliest FDA Approval

  2. Jul 31, 1973

    Bristol-Myers Squibb — NDA Secondary Org

  3. Jul 31, 1973

    Bristol-Myers — NDA Organization

1980s

  1. Jan 1, 1989

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1989

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Mar 10, 2000

    Hospira — Marketing Organization

  2. Jun 27, 2000

    Teva — Marketing Organization

  3. Oct 17, 2001

    West-Ward Pharmaceutical — Marketing Organization

  4. Oct 17, 2001

    Hikma — Marketing Organization

  5. Dec 13, 2007

    Pharmachemie Bv — Marketing Organization

  6. Jan 28, 2008

    Fresenius — Marketing Organization

2010s

  1. Apr 20, 2018

    Eu Yan Sang — Marketing Organization

  2. Apr 20, 2018

    Meitheal — Marketing Organization

  3. Mar 11, 2019

    Cipla — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

Approval history

  • approvedJul 31, 1973

Chemistry & pharmacology

Loading structure…

SMILES

Cc1c(N)nc([C@H](CC(N)=O)NC[C@H](N)C(N)=O)nc1C(=O)N[C@H](C(=O)N[C@H](C)[C@@H](O)[C@H](C)C(=O)N[C@H](C(=O)NCCc1nc(-c2nc(C(=O)NCCC[S+](C)C)cs2)cs1)[C@@H](C)O)[C@@H](O[C@@H]1O[C@@H](CO)[C@@H](O)[C@H](O)[C@@H]1O[C@H]1O[C@H](CO)[C@@H](O)[C@H](OC(N)=O)[C@@H]1O)c1c[nH]cn1.O=S(=O)(O)O
Mol. weight
1513.66 g/mol
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

  • blenoxane
  • blenoxane
  • blenoxane
  • bleocin
  • bleocin
  • bleo-kyowa
  • bleomicin
  • bleomicin
  • bleomicina
  • bleomicina
  • bleomycin
  • bleomycin
  • bleomycin
  • bleomycin
  • bleomycin
  • bleomycin
  • bleomycin
  • bleomycin
  • bleomycin
  • bleomycin a2
  • bleomycin a2
  • bleomycin a2 sulfate
  • bleomycine
  • bleomycine
  • bleomycin hcl
  • bleomycin hydrochloride
  • bleomycins
  • bleomycin sulfate
  • bleomycin sulfate
  • bleomycin sulfate
  • bleomycin sulfate
  • bleomycin (sulfate)
  • bleomycinum
  • bleomycinum
  • blm
  • blm

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07041749N/AJun 1, 2026Assiut University
NCT07201766N/ADec 2, 2025King Edward Medical University
NCT07197541Phase 4Oct 1, 2025Zhejiang University
NCT06718192N/ADec 1, 2024Zhejiang University
NCT06848569Phase 2Oct 23, 2024Sun Yat-Sen University
NCT06647342Phase 4Oct 18, 2024Roskilde University, University of Copenhagen
NCT07104526N/AJan 1, 2024Wuhan Integrated Traditional Chinese and Western Medicine Hospital
NCT06144736Phase 2Aug 28, 2023University of Duesseldorf
NCT05675410Phase 3May 11, 2023National Cancer Institute (NCI), State University of New York, Buffalo
NCT06437158Phase 2Mar 8, 2023Sichuan University
NCT07171827N/AMar 1, 2023Helwan University
NCT05395962Phase 2Apr 8, 2022University of Bologna
NCT04685616Phase 3Nov 30, 2021Canadian Cancer Trials Group, Takeda, University of London, University of Manchester
NCT05057663N/ANov 1, 2021Sohag University
NCT05008224Phase 2Oct 7, 2021Merck
NCT07239765Phase 3Jul 9, 2021Yiling Pharmaceutical Inc.
NCT06080724N/AMar 22, 2021King Edward Medical University
NCT05916690N/AMar 1, 2021University of Ljubljana
NCT04582305Phase 4Jan 31, 2021Erasmus University Rotterdam, Leiden University
NCT05023408Phase 2Jan 1, 2021Jinnah Postgraduate Medical Centre
Showing 20 of 191 trials
Page 1 / 10

Organizations

Research & Development (193)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government401641989
The Lymphoma Study AssociationAcademic/Hospital10421998
European Organisation for Research and Treatment of CancerAcademic/Hospital9911989
National Institute of Allergy and Infectious Diseases (NIAID)Government9841999
Stanford UniversityAcademic/Hospital9421989
University of CologneAcademic/Hospital9921998
University of CopenhagenAcademic/Hospital9741999
University of Texas at HoustonAcademic/Hospital9831993
Eastern Cooperative Oncology GroupAcademic/Hospital7221994
University of LondonAcademic/Hospital7331990
Cornell UniversityAcademic/Hospital6541994
Fondazione Italiana Diabete OnlusAcademic/Hospital5422006
Southwest Oncology GroupAcademic/Hospital5421994
Bristol-Myers SquibbFor profit4031999
Children's Cancer and Leukaemia GroupAcademic/Hospital4431989
Inovio PharmaceuticalsFor profit4422004
Medical Research CouncilGovernment4321997
Millennium PharmaceuticalsFor profit4132010
Seattle GeneticsFor profit4142010
St. Jude Children's HospitalAcademic/Hospital4412000
193 organizations
Page 1 / 10

Marketing (12)

OrganizationOrg typeRelationshipDate
Bristol-MyersFor profitNDAJul 31, 1973
Bristol-Myers SquibbFor profitNDA2Jul 31, 1973
CiplaFor profitMKTGMar 11, 2019
Eu Yan SangFor profitMKTGApr 20, 2018
FreseniusFor profitMKTGJan 28, 2008
HikmaFor profitMKTGOct 17, 2001
HospiraFor profitMKTGMar 10, 2000
MeithealFor profitMKTGApr 20, 2018
Pharmachemie BvFor profitMKTGDec 13, 2007
TevaFor profitSYNJun 3, 1996
TevaFor profitMKTGJun 27, 2000
West-Ward PharmaceuticalFor profitMKTGOct 17, 2001