Back to discover
Drug

Mitoxantrone

In clinical development
Emerging researchLate-stage development
Also known as Novantrone, Mitoxantrona, Mitozantrone, 1,4-Bis(2-(2-hydroxyethylamino)ethyl)amino)-5,8-dihydroxyanthraquinone+2 more

Novantrone, Mitoxantrona, Mitozantrone, 1,4-Bis(2-(2-hydroxyethylamino)ethyl)amino)-5,8-dihydroxyanthraquinone, MitoXANTRONE Hydrochloride, Mitoxantronum.

RxNorm7005ChEMBLCHEMBL58ATCL01DB07UNIIBZ114NVM5P
1
Research papers
15
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Clinical trial2026-07-16Results posted · ClinicalTrials.gov

A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML

Clinical trial2026-07-09Results expected Q2 2029 · ClinicalTrials.gov

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

Clinical trial2026-06-29Results expected Q4 2031 · ClinicalTrials.gov

Randomized Phase 2 Trial of CPX-351 (Vyxeos) vs. CLAG-M (Cladribine, Cytarabine, G-CSF, and Mitoxantrone) in Medically Less-Fit Adults With Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm

Clinical trial2026-06-29Results posted · ClinicalTrials.gov

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Clinical trial2026-06-18Results expected Q2 2029 · ClinicalTrials.gov

A Phase 1 Study of M3814 in Combination With MEC in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Clinical trial2026-06-11Results expected Q2 2027 · ClinicalTrials.gov

Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Clinical trial2026-06-03Results expected Q4 2028 · ClinicalTrials.gov

A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

Clinical trial2026-06-02Results posted · ClinicalTrials.gov

A Phase 1/2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms

Clinical trial2026-04-17Results expected Q4 2027 · ClinicalTrials.gov

Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines [RETIRED].

Research2002-01-01Neurology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mitoxantrone
Aliases & brands
NovantroneMitoxantronaMitozantrone1,4-Bis(2-(2-hydroxyethylamino)ethyl)amino)-5,8-dihydroxyanthraquinoneMitoXANTRONE HydrochlorideMitoxantronum
RxNorm CUI
7005
ChEMBL ID
CHEMBL58
ATC codes
L01DB07
UNII
BZ114NVM5P

Clinical trials

199 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
199
registered trials across all phases
LATEST COMPLETION 2026
15
Active studies
6
Recruiting
56
Late-stage (III+)
128
Completed
56
Discontinued
PHASE DISTRIBUTIONn = 199
Phase 136Phase 1 / 225Phase 282Phase 2 / 32Phase 343Phase 48Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Application of Mitoxantrone Hydrochloride Injection in Transoral Robotic Thyroid Cancer Surgery

Not yet recruitingPH IVDaping Hospital and the Research Institute of Surgery of the Third Military Medical Universityn=1142028

A Multicenter and Randomized Prospective Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia

CompletedPH IVSouth China Children's Leukemia Groupn=1762021

Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders

Unknown statusPH IVXuanwu Hospital, Beijingn=502015

Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005): Remission Induction With ATRA + Idarubicin. Risk-adapted Consolidation With ATRA and Anthracycline-based Chemotherapy (Idarubicin/Mitoxantrone) With Addition of Ara-C for High-risk Patients. Maintenance Therapy With ATRA + Low Dose Chemotherapy (Methotrexate + Mercaptopurine).

CompletedPH IVPETHEMA Foundationn=3002013

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

CompletedPH IVPETHEMA Foundationn=1002012

Recent completions

Trials that read out recently, adding to the completed evidence base.

Randomized Phase 2 Trial of CPX-351 (Vyxeos) vs. CLAG-M (Cladribine, Cytarabine, G-CSF, and Mitoxantrone) in Medically Less-Fit Adults With Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm

CompletedPH IIFred Hutchinson Cancer Centern=602026

Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

CompletedPH IIIArog Pharmaceuticals, Inc.n=1062026

A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

CompletedPH IIIKey trialNational Cancer Institute (NCI)n=1,6452026

Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

CompletedPH IAmgenn=1412024

A Phase I Study of Lintuzumab-Ac225 in Combination with CLAG-M Chemotherapy in Patients with Relapsed/Refractory Acute Myeloid Leukemia

CompletedPH IMedical College of Wisconsinn=262024

Addition of Sorafenib to G-CSF, Cladribine, Cytarabine and Mitoxantrone (G-CLAM) in Adults With Newly-Diagnosed Acute Myeloid Leukemia (AML) Independent of FLT3-ITD Status: A Phase 1/2 Study

CompletedPH I/IIUniversity of Washingtonn=842023

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Neurology1
Leading researchers
  • Frohman EM1
  • Garmany GP Jr1
  • Goodin DS1
  • Halper J1
  • Likosky WH1
  • Lublin FD1
  • Silberberg DH1
  • Stuart WH1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Glatiramer Acetate

Studied across the same disease area as Mitoxantrone in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials