mitoxantrone
Trade name: novantrone
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
Earliest trial started Feb 1, 1991 (NCT00002474)
Timeline
1980s
- Jul 13, 1987
Orphan Drug Designation
- Dec 23, 1987
Merck Serono — Earliest FDA Approval
- Dec 23, 1987
Merck Serono — NDA Secondary Org
- Dec 23, 1987
Merck Serono — NDA Organization
1990s
2000s
- Oct 13, 2000
Serono — NDA Secondary Org
- Apr 11, 2006
Meitheal — Marketing Organization
- Apr 11, 2006
Hospira — Marketing Organization
- Apr 11, 2006
Teva — Marketing Organization
- Apr 11, 2006
West-Ward Pharmaceutical — Marketing Organization
- Apr 11, 2006
Hikma — Marketing Organization
- Apr 11, 2006
Eu Yan Sang — Marketing Organization
- May 14, 2008
Fresenius — Marketing Organization
- Apr 13, 2009
Mylan — Marketing Organization
- Apr 13, 2009
Rising Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Adolescent · Phase 2
- Antigens, Neoplasm · Early Phase 1
- Autoimmune Diseases of the Nervous System · Phase 4
- Breast Neoplasms · Phase 3
- Burkitt Lymphoma · Phase 2
- Carcinoma, Hepatocellular · Phase 2
- Child · Phase 2
- Demyelinating Autoimmune Diseases, CNS · Phase 4
- Down Syndrome · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Hematopoietic Stem Cell Transplantation · Phase 2
- HIV Infections · Phase 2
- Leukemia · Phase 3
- Leukemia, B-Cell · Phase 2
- Leukemia, Biphenotypic, Acute · Phase 2
- Leukemia, Eosinophilic, Acute · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 4
- Leukemia, Lymphoid · Phase 2
- Leukemia, Monocytic, Acute · Phase 2/Phase 3
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid · Phase 3
- Leukemia, Myeloid, Acute · Phase 4
- Leukemia, Myelomonocytic, Acute · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 1
- Leukemia, Prolymphocytic · Phase 2
- Leukemia, Prolymphocytic, T-Cell · Phase 2
- Leukemia, Promyelocytic, Acute · Phase 4
- Leukemia, T-Cell · Phase 2
- Lung Diseases · Phase 3
- Lymphoma · Phase 3
- Lymphoma, B-Cell · Phase 2
- Lymphoma, Extranodal NK-T-Cell · Phase 3
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 3
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Peripheral · Phase 3
- Multiple Myeloma · Phase 4
- Multiple Sclerosis · Phase 3
- Multiple Sclerosis, Chronic Progressive · Phase 3
- Multiple Sclerosis, Relapsing-Remitting · Phase 2
- Myelitis, Transverse · Phase 4
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 3
- Nasopharyngeal Carcinoma · Phase 3
- Neoplasm Metastasis · Phase 1
- Neuromyelitis Optica · Phase 4
- Neutropenia · Phase 3
- Non-alcoholic Fatty Liver Disease · Phase 1
- Ovarian Neoplasms · Phase 3
- Pain · Phase 3
- Pancreatic Neoplasms · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 3
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Prognosis · Phase 2
- Prostatic Neoplasms · Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 3
- Quality of Life · Phase 3
- Sarcoma · Phase 2
- Sarcoma, Kaposi · Phase 2
- Sarcoma, Myeloid · Phase 3
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 1
- Stomach Neoplasms · Phase 1
- Therapeutics · Phase 1/Phase 2
- T-Lymphocytes · Phase 2
- Translocation, Genetic · Early Phase 1
Mechanism of action
- DNA topoisomerase II alphaINHIBITOR
TOP2A inhibitor
- DNAINHIBITOR
DNA inhibitor
Approval history
- approvedDec 23, 1987
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL58 ↗
- WikipediaMitoxantrone ↗
- NCATSBZ114NVM5P ↗
- ChEMBLCHEMBL1417019 ↗
- ChEMBLCHEMBL1024 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07288814 | Phase 1/Phase 2 (Phase 2) | Dec 8, 2025 | Sun Yat-Sen University, Yiling Pharmaceutical Inc. |
| NCT07168317 | Phase 2 | Aug 1, 2025 | Xuzhou Medical University |
| NCT07093710 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2025 | Sun Yat-Sen University |
| NCT07070479 | Phase 2 | Jun 24, 2025 | Sun Yat-Sen University |
| NCT07028086 | Phase 2 | Jun 20, 2025 | Jiao Tong University |
| NCT06953739 | Phase 3 | May 1, 2025 | Nanjing Medical University |
| NCT06921044 | Phase 2 | Apr 16, 2025 | Chinese Academy of Medical Sciences, Yiling Pharmaceutical Inc. |
| NCT06892431 | Phase 2 | Apr 1, 2025 | Shanghai JMT-Bio Inc. |
| NCT07058103 | Phase 2 | Apr 1, 2025 | Xuzhou Medical University |
| NCT06761417 | Phase 2 | Feb 1, 2025 | Chinese Academy of Medical Sciences |
| NCT06758726 | N/A | Dec 31, 2024 | China Academy of Chinese Medical Sciences |
| NCT06429449 | Phase 1 | Dec 31, 2024 | The Leukemia and Lymphoma Society, University of Colorado, Denver |
| NCT06660368 | Phase 2 | Nov 30, 2024 | AbbVie, University of South Florida |
| NCT06741722 | Phase 2 | Oct 31, 2024 | People's Liberation Army of China |
| NCT06651866 | Phase 1 | Oct 22, 2024 | Xiamen University |
| NCT06475287 | Phase 2 | Jul 20, 2024 | Fudan University |
| NCT06486337 | Phase 2 | Jul 10, 2024 | Soochow University |
| NCT06621199 | Phase 2 | Jul 8, 2024 | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Zhejiang University |
| NCT06621212 | N/A | Jul 5, 2024 | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Zhejiang University |
| NCT06514313 | Phase 2 | Jul 3, 2024 | Sun Yat-Sen University |
Organizations
Research & Development (311)
Marketing (15)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Eu Yan Sang | For profit | MKTG | Apr 11, 2006 |
| Fresenius | For profit | MKTG | May 14, 2008 |
| Fresenius | For profit | SYN | Apr 11, 2006 |
| Hikma | For profit | SYN | Apr 11, 2006 |
| Hikma | For profit | MKTG | Apr 11, 2006 |
| Hospira | For profit | MKTG | Apr 11, 2006 |
| Meitheal | For profit | MKTG | Apr 11, 2006 |
| Merck Serono | For profit | NDA2 | Dec 23, 1987 |
| Merck Serono | For profit | NDA | Dec 23, 1987 |
| Mylan | For profit | MKTG | Apr 13, 2009 |
| Mylan | For profit | SYN | Dec 11, 2012 |
| Rising Pharmaceuticals | For profit | MKTG | Apr 13, 2009 |
| Serono | For profit | NDA2 | Oct 13, 2000 |
| Teva | For profit | MKTG | Apr 11, 2006 |
| West-Ward Pharmaceutical | For profit | MKTG | Apr 11, 2006 |