mitoxantrone

Trade name: novantrone

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 23, 1987

Mitoxantrone (NOVANTRONE) is a synthetic antineoplastic anthracenedione. Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA. It has a cytocidal effect on both proliferating and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity. Mitoxantrone has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen pre sentation, as well as the secretion of interferon gamma, TNFα, and IL-2. NOVANTRONE is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). NOVANTRONE in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. NOVANTRONE in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias. — NCATS

Clinical trial activity

350 trials · 311 clinical orgs · 11 marketing orgs

Phase 1
106
Phase 2
253
Phase 3
70
Phase 4
12

Earliest trial started Feb 1, 1991 (NCT00002474)

Timeline

1980s

  1. Jul 13, 1987

    Orphan Drug Designation

  2. Dec 23, 1987

    Merck Serono — Earliest FDA Approval

  3. Dec 23, 1987

    Merck Serono — NDA Secondary Org

  4. Dec 23, 1987

    Merck Serono — NDA Organization

1990s

  1. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1992

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Oct 13, 2000

    Serono — NDA Secondary Org

  2. Apr 11, 2006

    Meitheal — Marketing Organization

  3. Apr 11, 2006

    Hospira — Marketing Organization

  4. Apr 11, 2006

    Teva — Marketing Organization

  5. Apr 11, 2006

    West-Ward Pharmaceutical — Marketing Organization

  6. Apr 11, 2006

    Hikma — Marketing Organization

  7. Apr 11, 2006

    Eu Yan Sang — Marketing Organization

  8. May 14, 2008

    Fresenius — Marketing Organization

  9. Apr 13, 2009

    Mylan — Marketing Organization

  10. Apr 13, 2009

    Rising Pharmaceuticals — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedDec 23, 1987

Chemistry & pharmacology

Loading structure…

SMILES

O=C1c2c(O)ccc(O)c2C(=O)c2c(NCCNCCO)ccc(NCCNCCO)c21
Mol. weight
444.49 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 1,4-dihydroxy-5,8-bis({2-[(2-hydroxyethyl)amino]ethyl}amino)-9,10-anthracenedione
  • 1,4-dihydroxy-5,8-bis({2-[(2-hydroxyethyl)amino]ethyl}amino)-9,10-anthracenedione
  • cabazitaxel, docetaxel, mitoxantrone or satraplatin
  • cl-232315
  • cl-232315
  • dihydroxyanthraquinone
  • liposomal mitoxantrone
  • mitoxana
  • mitoxana
  • mitoxana
  • mitoxanthrone
  • mitoxantrona
  • mitoxantrona
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone
  • mitoxantrone dihcl
  • mitoxantrone dihcl
  • mitoxantrone dihydrochloride
  • mitoxantrone dihydrochloride
  • mitoxantrone dihydrochloride
  • mitoxantrone dihydrochloride
  • mitoxantrone hcl
  • mitoxantrone hcl
  • mitoxantrone hcl
  • mitoxantrone hydrochloride
  • mitoxantrone hydrochloride
  • mitoxantrone hydrochloride
  • mitoxantronum
  • mitoxantronum
  • mitozantrone
  • mitozantrone
  • mitozantrone
  • mitozantrone
  • nimitoxantron
  • novantrone
  • novantrone
  • novantrone
  • novantrone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07288814Phase 1/Phase 2 (Phase 2)Dec 8, 2025Sun Yat-Sen University, Yiling Pharmaceutical Inc.
NCT07168317Phase 2Aug 1, 2025Xuzhou Medical University
NCT07093710Phase 1/Phase 2 (Phase 2)Aug 1, 2025Sun Yat-Sen University
NCT07070479Phase 2Jun 24, 2025Sun Yat-Sen University
NCT07028086Phase 2Jun 20, 2025Jiao Tong University
NCT06953739Phase 3May 1, 2025Nanjing Medical University
NCT06921044Phase 2Apr 16, 2025Chinese Academy of Medical Sciences, Yiling Pharmaceutical Inc.
NCT06892431Phase 2Apr 1, 2025Shanghai JMT-Bio Inc.
NCT07058103Phase 2Apr 1, 2025Xuzhou Medical University
NCT06761417Phase 2Feb 1, 2025Chinese Academy of Medical Sciences
NCT06758726N/ADec 31, 2024China Academy of Chinese Medical Sciences
NCT06429449Phase 1Dec 31, 2024The Leukemia and Lymphoma Society, University of Colorado, Denver
NCT06660368Phase 2Nov 30, 2024AbbVie, University of South Florida
NCT06741722Phase 2Oct 31, 2024People's Liberation Army of China
NCT06651866Phase 1Oct 22, 2024Xiamen University
NCT06475287Phase 2Jul 20, 2024Fudan University
NCT06486337Phase 2Jul 10, 2024Soochow University
NCT06621199Phase 2Jul 8, 2024CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Zhejiang University
NCT06621212N/AJul 5, 2024CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Zhejiang University
NCT06514313Phase 2Jul 3, 2024Sun Yat-Sen University
Showing 20 of 350 trials
Page 1 / 18

Organizations

Research & Development (311)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government712841994
Shijiazhuang Pharma Group (CSPC)For profit292632011
University of WashingtonAcademic/Hospital171631994
Sun Yat-Sen UniversityAcademic/Hospital13952011
Chinese Academy of Medical SciencesAcademic/Hospital11632011
Yiling Pharmaceutical Inc.For profit11132018
University of Texas at HoustonAcademic/Hospital10741994
St. Jude Children's HospitalAcademic/Hospital9832002
European Organisation for Research and Treatment of CancerAcademic/Hospital8821993
Jiao Tong UniversityAcademic/Hospital8752010
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.For profit7442021
Nanjing Medical UniversityAcademic/Hospital7732023
PfizerFor profit7521998
China Academy of Chinese Medical SciencesAcademic/Hospital6622023
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital6231995
Johns Hopkins UniversityAcademic/Hospital6022001
AmgenFor profit5221998
BayerFor profit5011999
Cornell UniversityAcademic/Hospital5531994
GenentechFor profit5021998
311 organizations
Page 1 / 16

Marketing (15)

OrganizationOrg typeRelationshipDate
Eu Yan SangFor profitMKTGApr 11, 2006
FreseniusFor profitMKTGMay 14, 2008
FreseniusFor profitSYNApr 11, 2006
HikmaFor profitSYNApr 11, 2006
HikmaFor profitMKTGApr 11, 2006
HospiraFor profitMKTGApr 11, 2006
MeithealFor profitMKTGApr 11, 2006
Merck SeronoFor profitNDA2Dec 23, 1987
Merck SeronoFor profitNDADec 23, 1987
MylanFor profitMKTGApr 13, 2009
MylanFor profitSYNDec 11, 2012
Rising PharmaceuticalsFor profitMKTGApr 13, 2009
SeronoFor profitNDA2Oct 13, 2000
TevaFor profitMKTGApr 11, 2006
West-Ward PharmaceuticalFor profitMKTGApr 11, 2006