Wednesday, July 8, 2026

Drug profile · INN

mitoxantrone hydrochloride

mitoxantrone hydrochloride (MITOXANTRONE HYDROCHLORIDE) is a dna topoisomerase ii alpha inhibitor. Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 12
News articles 0
Drug details — mitoxantrone hydrochloride
US status
approved
Class
Route
INJECTION
Patents
0
Programs
12
Data quality
0.84

Quick answer

mitoxantrone hydrochloride (MITOXANTRONE HYDROCHLORIDE) is a dna topoisomerase ii alpha inhibitor. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN mitoxantrone hydrochloride
Brand MITOXANTRONE HYDROCHLORIDE
Mechanism DNA topoisomerase II alpha inhibitor
Target DNA
Route INJECTION
Formulation INJECTABLE

Mechanism of action

DNA topoisomerase II alpha inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 09 Phase 3 · First People's Hospital · Acute Myeloid Leukaemia
  2. Mitoxantrone Hydrochloride Liposome Phase 3 · First People's Hospital · Acute Myeloid Leukemia (AML)
  3. 2023-SR-002 Phase 2 · First People's Hospital · NK-T-Cell Lymphoma, Extranodal
  4. B1931036 Phase 2 · First Biotech (Australia) · Acute Lymphoblastic Leukemia (ALL)
  5. Mitoxantrone Hydrochloride Liposome Phase 2 · Chinese Academy of · Diffuse Large B-cell Lymphoma
  6. Mitoxantrone liposome Phase 2 · First People's Hospital · Relapsed or Refractory Acute Myeloid Leukemia
  7. mitoxantrone hydrochloride liposome Phase 2 · First People's Hospital · Relapsed/Refractory Acute Myeloid Leukaemia
  8. mitoxantrone liposome 16 and azacitidine Phase 2 · NovaBridge Biosciences · Angioimmunoblastic T-cell Lymphoma

Related & competitor drugs

  1. acyclovir Human herpesvirus 1 DNA polymerase inhibitor
  2. acyclovir sodium Human herpesvirus 1 DNA polymerase inhibitor
  3. azacitidine Antineoplastic and immunomodulating agents (L01)
  4. bleomycin sulfate DNA inhibitor
  5. busulfan Antineoplastic and immunomodulating agents (L01)
  6. capecitabine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is mitoxantrone hydrochloride?

mitoxantrone hydrochloride (MITOXANTRONE HYDROCHLORIDE) is a dna topoisomerase ii alpha inhibitor. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for mitoxantrone hydrochloride?

MITOXANTRONE HYDROCHLORIDE is a marketed brand name for mitoxantrone hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mitoxantrone hydrochloride?

mitoxantrone hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.