Mitoxantrone Hydrochloride

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Cat Number

API70476823

CAS Number

70476-82-3

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CAS Number

70476-82-3

EINECS

274-619-1

Storage

Store at 2-8°C

Synonyms

Mitoxantrone dihydrochloride; CL-232315; Onkotrone; DTXSID0045173; U6USW86RD0

Molecular Formula

C22H30Cl2N4O6

Molecular Weight

517.4

Smiles

C1=CC(=C2C(=C1NCCNCCO)C(=O)C3=C(C=CC(=C3C2=O)O)O)NCCNCCO.Cl.Cl

Appearance

Dark blue to blue-black crystalline powder

Melting Point

203-205°C

General Description

Mitoxantrone hydrochloride is a synthetic anthracenedione derivative with two hydroxyethylamino side chains, belonging to the class of anthracenedione antineoplastic agents. Its chemical structure is 1,4-dihydroxy-5,8-bis[2-(2-hydroxyethylamino)ethylamino]anthracene-9,10-dione hydrochloride. Mitoxantrone is a dark blue to blue-black crystalline powder, soluble in water. It is a potent inhibitor of topoisomerase II.

Mechanism of Action

Mitoxantrone intercalates into DNA and inhibits the enzyme topoisomerase II, preventing the religation of DNA strands and causing double-strand breaks. This leads to the inhibition of DNA replication and transcription, and the induction of apoptosis. The drug is cell cycle non-specific, but has a greater effect on rapidly dividing cells. It also has immunosuppressive properties by inhibiting the proliferation of lymphocytes.

Application

Mitoxantrone is indicated for the treatment of advanced prostate cancer (in combination with corticosteroids), acute myeloid leukemia, and non-Hodgkin's lymphoma. It is also used for the management of secondary progressive multiple sclerosis (MS) to reduce the frequency of relapses and slow disease progression.

In a prospective study of 20 patients with relapsed/refractory acute myeloid leukemia, liposomal mitoxantrone (Lipo-MIT)-based regimens achieved a composite complete remission rate of 60% after one induction course. Among patients who relapsed after allogeneic stem cell transplantation (n=13), the CRc rate was 69.2%. The MAC regimen (Lipo-MIT, cytarabine, cyclophosphamide) was most commonly used. Hematologic grade 3/4 toxicities were frequent (95%). Median overall survival was 9.99 months. Lipo-MIT regimens show preliminary efficacy, particularly in post-transplant relapse, though myelosuppression requires close monitoring.

Fig. 1 Treatment response after one cycle treatment between two groups. (Lu N, et al., 2025)

References

Lu N, et al. Efficacy and safety of mitoxantrone hydrochloride liposome-containing regimens in treating refractory/relapsed acute myeloid leukemia. Discov Oncol. 2025;16(1):727.

In a phase I dose‑escalation study of liposomal mitoxantrone (Lipo‑MIT) plus capecitabine in 26 pretreated HER2‑negative advanced breast cancer patients, the recommended phase 2 dose was Lipo‑MIT 22 mg/m² every 4 weeks. The combination was manageable, with no severe cardiac toxicity or hand‑foot syndrome and interstitial lung disease occurred in 19.2% (grade 1‑2). In the Q4W cohort, objective response rate was 36.4% and median PFS 12.7 months. Further evaluation in phase II/III trials is warranted.

Fig. 2 Study design and dose-escalation scheme. (Liu J, et al., 2026)

References

Liu J, et al. Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with capecitabine in HER2-negative advanced breast cancer: a dose-escalation, phase I study. BMC Med. 2026;24(1):356.

Does Mitoxantrone Hydrochloride require protection from light and heat during storage?

Yes, it is highly sensitive to light and heat. Light causes photodegradation and heat accelerates oxidation of the anthracenedione ring. Store in light‑resistant containers at 2–8°C.

Is Mitoxantrone Hydrochloride stable in solution for intravenous infusion?

Reconstituted solutions are stable for up to 24 hours under refrigeration when protected from light.

What is the recommended packaging for Mitoxantrone Hydrochloride to prevent degradation?

Use amber glass vials with PTFE‑lined caps, sealed under nitrogen. Store in refrigerated conditions and protect from light during handling.

How is the impurity mitoxantrone dimer (an aggregation product) monitored during stability?

This degradation product is quantified using a stability‑indicating HPLC method or SEC‑HPLC, ensuring it remains within ICH limits.