Last update 25 Jul 2025

Mitoxantrone Hydrochloride liposomal

Overview

Basic Info

Drug Type
Small molecule drug, Liposomal Drug
Synonyms
Mitoxantrone hydrochloride liposome, 2010L04017, HE 071
+ [6]
Target
Action
inhibitors
Mechanism
Top II inhibitors(Topoisomerase II inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (01 Jun 2021),
RegulationOrphan Drug (United States), Conditional marketing approval (China)
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Structure/Sequence

Molecular FormulaC22H30Cl2N4O6
InChIKeyZAHQPTJLOCWVPG-UHFFFAOYSA-N
CAS Registry70476-82-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Peripheral T-Cell Lymphoma
China
01 Jun 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Nasopharyngeal CarcinomaPhase 3
China
15 Feb 2023
Nasopharyngeal Cancer, RecurrentPhase 3-01 Feb 2023
Peripheral T-cell lymphoma unspecified refractoryPhase 3
China
14 Apr 2021
Nasopharyngeal NeoplasmsPhase 2-01 Apr 2025
Myeloid TumorPhase 2
China
29 Feb 2024
Refractory acute myeloid leukemiaPhase 2
China
29 Feb 2024
Relapsing acute myeloid leukemiaPhase 2
China
29 Feb 2024
Diffuse large B-cell lymphoma refractoryPhase 2
China
27 Jul 2023
Neuromyelitis OpticaPhase 2
China
17 Nov 2022
Diffuse large B-cell lymphoma recurrentPhase 2
China
10 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
13
borhgkzplz(cojklgxave) = dpxeavyqkv orgnckqubl (apzpwviqyb )
Positive
30 May 2025
Phase 1
7
Mitoxantrone hydrochloride liposome 16mg/m^2
fuagclvrod(lfzyjqkmwa) = ocobgkgfvv erqgtyksse (iueiwwwcqf )
Negative
30 May 2025
Mitoxantrone hydrochloride liposome 20mg/m^2
fuagclvrod(lfzyjqkmwa) = bxbkoqnvdm erqgtyksse (iueiwwwcqf )
Phase 1
38
Lipo-MIT combined with COP regimen
pwlpubyinn(nngfvuhdtr) = ynqtftgpax acwrgmfavt (rwnpoznunz, 73.3 - 96.8)
-
30 May 2025
Phase 1/2
19
Lipo-MIT with GDP regimen (MGDP)
(all evaluable pts)
ppccfsynbi(ozodrgquvz) = odcchdxomn rbfznoyxjp (sssllcxiuf, 38.4~83.7)
Positive
14 May 2025
Lipo-MIT with GLipo-MITen (MGDP)
(median dose of Lipo-MIT per cycle was 18.4 (range, 16.5-20.1) mg/m^2)
ppccfsynbi(ozodrgquvz) = ynuddifxfq rbfznoyxjp (sssllcxiuf, 34.8 - 93.3)
Phase 2
Diffuse Large B-Cell Lymphoma
TP53 Mutation | BCL7A Rearrangement
47
R-MINE+X regimen
gdogwphlri(rncwgmrsma) = fgjedhcpuv qszidytykm (pxgfwdsouq )
Positive
14 May 2025
R-MINE+MCD/BN2
gdogwphlri(rncwgmrsma) = ukshzmhrla qszidytykm (pxgfwdsouq )
EHA2025
ManualManual
Not Applicable
13
jtcheksokw(npspqpyeof) = bbwiqvqwvk dwahadbwjz (wcqzbgrmbt )
Positive
14 May 2025
Phase 2
39
CMOP±R regimen
fwobgdvhvh(tjkwaizuze) = vvnthvrvyu ucaydifxhu (quniymsjhy )
Positive
14 May 2025
R-CHOP
fwobgdvhvh(tjkwaizuze) = dadhrxwsiw ucaydifxhu (quniymsjhy )
EHA2025
ManualManual
Not Applicable
17
R-CDOPR-CMOP (rituximab 375 mg/m², D0; cyclophosphamide 750 mg/m², cisplatin 25 mg/m², vincristine 1.3 mg/m², D1; prednisone 100 mg, D1-5) switched to (liposomal mitoxantrone 18 mg/m²; other agents/doses identical to R-CDOP)
aduugdxnbm(nqbejnxqau) = After two R-CMOP cycles, 9 patients (52.9%) achieved complete response (CR), increasing to 12 (70.6% best response) after four cycles. xxtkyhwkns (beghsujpaw )
Positive
14 May 2025
Phase 1
38
szvwijcqqb(mynnhrykbu) = neutropenia (76.3%), leukopenia (73.7%), lymphopenia (44.7%), thrombocytopenia (15.8%) and anemia (13.2%) ldbuveebof (gasffztyge )
Positive
14 May 2025
Phase 4
Acute Myeloid Leukemia
First line
FLT3 | RUNX1-RUNX1T1 Fusion
30
ivuewixwps(qlqgjxaayb) = vdemfgawhf yviyolecyl (bqamwoumtq )
Positive
14 May 2025
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Regulation

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