MITOXANTRONE HYDROCHLORIDE

Post-LOE

mitoxantrone

Pfizer

ANDAINJECTIONINJECTABLE

Approved

Apr 2006

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

MITOXANTRONE HYDROCHLORIDE (mitoxantrone) by Pfizer is mechanism of action mitoxantrone, a dna-reactive agent that intercalates into deoxyribonucleic acid (dna) through hydrogen bonding, causes crosslinks and strand breaks. Approved for the treatment of patients with primary progressive multiple sclerosis, the initial therapy of acute nonlymphocytic leukemia (anll) in adults, multiple sclerosis and 1 more indications. First approved in 2006.

Drug data last refreshed 18h ago

Mechanism of Action

Mechanism of Action 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…

Indications (4)

the treatment of patients with primary progressive multiple sclerosis the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (20)

NCT06892431Phase 2Not Yet Recruiting

JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer

Started Apr 2025

150 enrolled

Recurrent or Metastatic Nasopharyngeal CancerPatients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy

NCT06429449Phase 1Recruiting

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

Started Jul 2024

30 enrolled

LeukemiaMyeloid LeukemiaMonocytic Leukemia

NCT05441761Phase 1/2Unknown

Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL

Started May 2022

60 enrolled

TreatmentPeripheral T-cell Lymphoma

NCT06220097Phase 2Active Not Recruiting

Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies

Started Feb 2022

28 enrolled

B-cell Acute Lymphoblastic LeukemiaB-cell Lymphoma Refractory

NCT03989713Phase 2Terminated

Quizartinib and High-dose Ara-C Plus Mitoxantrone in Relapsed/Refractory AML With FLT3-ITD

Started Jul 2020

11 enrolled

AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment)