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Mitoxantrone

Generic Name
Mitoxantrone
Drug Type
Small Molecule
Chemical Formula
C22H28N4O6
CAS Number
65271-80-9
Unique Ingredient Identifier
BZ114NVM5P

Overview

An anthracenedione-derived antineoplastic agent.

Indication

For the treatment of secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis

Associated Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myeloid Leukemia
  • Acute Promyelocytic Leukemia
  • Hodgkin's Lymphoma
  • Metastatic Breast Cancer
  • Non-Hodgkin's Lymphoma (NHL)
  • Progressive Relapsing Multiple Sclerosis
  • Relapsed Leukemia
  • Relapsed Lymphomas
  • Relapsing Remitting Multiple Sclerosis (RRMS)
  • Secondary Progressive Multiple Sclerosis (SPMS)
  • Hormone refractory, advanced Prostate cancer
  • Relapsed Hepatocellular carcinoma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/24
Phase 2
Not yet recruiting
Shanghai JMT-Bio Inc.
2025/01/07
Phase 2
Not yet recruiting
2024/10/01
Not Applicable
Recruiting
First Affiliated Hospital of Zhejiang University
2024/10/01
Phase 2
Recruiting
First Affiliated Hospital of Zhejiang University
2024/09/19
Phase 1
Recruiting
2024/07/23
Phase 2
Recruiting
Yizhuo Zhang
2024/07/12
Early Phase 1
Recruiting
BGI, China
2024/07/08
Phase 2
Recruiting
2024/06/25
Phase 2
Recruiting
Ming-Yuan Chen
2024/06/06
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Hospira, Inc.
61703-343
INTRAVENOUS
2 mg in 1 mL
4/15/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
MITOXANTRONE BAXTER INJECTION 2 mg/ml
SIN11629P
INJECTION
2 mg/ml
8/15/2001

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Mitoxantrone Hydrochloride Liposome Injection
国药准字H20220001
化学药品
注射剂
1/7/2022
Mitoxantrone Hydrochloride Sodium Chloride Injection
国药准字H10980248
化学药品
注射剂(注射液)
12/2/2020
Mitoxantrone Hydrochloride for Injection
国药准字H10960120
化学药品
注射剂(冻干)
6/1/2020
Mitoxantrone Hydrochloride for Injection
国药准字H20057796
化学药品
注射剂
7/7/2020
Mitoxantrone Hydrochloride for Injection
国药准字H20056427
化学药品
注射剂(冻干粉针剂)
5/20/2020
Mitoxantrone Hydrochloride for Injection
国药准字H32020964
化学药品
注射剂
8/31/2020
Mitoxantrone Hydrochloride for Injection
国药准字H20060894
化学药品
注射剂
1/14/2021
Mitoxantrone Hydrochloride for Injection
国药准字H20093281
化学药品
注射剂
6/17/2020
Mitoxantrone Hydrochloride Injection
国药准字H10960192
化学药品
注射剂(注射液)
12/10/2020
Mitoxantrone Hydrochloride Injection
国药准字H10960190
化学药品
注射剂(注射液)
12/10/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

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