Last update 09 Dec 2025

Doxorubicin Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DOX, DOX@3D-MPs, doxorubicin
+ [35]
Target
Action
inhibitors
Mechanism
Top II inhibitors(Topoisomerase II inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC27H30ClNO11
InChIKeyMWWSFMDVAYGXBV-RUELKSSGSA-N
CAS Registry25316-40-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
AIDS-related Kaposi Sarcoma
Japan
04 Jan 2007
Kaposi Sarcoma
Japan
04 Jan 2007
acute leukemia
Brazil
20 Nov 2006
Hepatocellular Carcinoma
Brazil
20 Nov 2006
Non-Hodgkin Lymphoma
Brazil
20 Nov 2006
Soft Tissue Sarcoma
Brazil
20 Nov 2006
Bone Cancer
Japan
14 Feb 2005
Bone Tissue Neoplasms
Japan
14 Feb 2005
Childhood Malignant Solid Neoplasm
Japan
14 Feb 2005
Endometrial Carcinoma
Japan
14 Feb 2005
Ewing Sarcoma
Japan
14 Feb 2005
Hepatoblastoma
Japan
14 Feb 2005
Multiple Myeloma
Japan
14 Feb 2005
Retinoblastoma
Japan
14 Feb 2005
Rhabdomyosarcoma
Japan
14 Feb 2005
Soft Tissue Neoplasms
Japan
14 Feb 2005
Transitional Cell Carcinoma
Japan
03 Jan 2004
Lung Cancer
China
01 Jan 2001
Stomach Cancer
United States
23 Dec 1987
Ovarian Cancer
United States
23 Dec 1987
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsNDA/BLA
China
30 Jan 2022
NeoplasmsNDA/BLA
China
30 Jan 2022
Relapse multiple myelomaPhase 3
United States
01 Dec 2004
Relapse multiple myelomaPhase 3
Argentina
01 Dec 2004
Relapse multiple myelomaPhase 3
Australia
01 Dec 2004
Relapse multiple myelomaPhase 3
Austria
01 Dec 2004
Relapse multiple myelomaPhase 3
Belgium
01 Dec 2004
Relapse multiple myelomaPhase 3
Canada
01 Dec 2004
Relapse multiple myelomaPhase 3
Czechia
01 Dec 2004
Relapse multiple myelomaPhase 3
France
01 Dec 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
452
BV-CHP
vofikywoyq(xxfnrxvttw): HR = 0.38 (95.0% CI, 0.16 - 0.94)
Positive
09 Dec 2025
CHOP
Phase 2
100
qjqewxqcnl = mvevnrxhzs zzxdsgzrma (yrbvfwaayf, mjmjyaztqr - xskjzqusko)
-
20 Oct 2025
Phase 2
Locally advanced breast cancer
Neoadjuvant
HER-2 positive | hormone-receptors positive
100
uyleanisvs(pjjmbwetcu) = goysoixdbg hcbuvbkfal (himxfbpiso )
Positive
17 Oct 2025
uyleanisvs(pjjmbwetcu) = mrillufdil hcbuvbkfal (himxfbpiso )
Not Applicable
929
cyclophosphamide+doxorubicin-based regimens
rxplhgrtpz(bocupgjxvg) = the majority of pts (55.5%) received only 1 line of therapy (LOT) for a median duration of 3.3 months. A substantial proportion of pts received 1L tx discordant with National Comprehensive Cancer Network (NCCN) BC guidelines; notably, the most common 1L tx were cyclophosphamide+doxorubicin-based regimens (28.1%). Other common 1L regimens included capecitabine (12.7%) and paclitaxel (10.4%). Among pts with ≥2 LOT (44.5%), the most common 2L regimens were capecitabine (16.2%), sacituzumab govitecan (14.8%), and carboplatin+gemcitabine (7.7%). mdyolrhicc (ylhopxquif )
Negative
17 Oct 2025
Not Applicable
56
mNewcastle regimen
domlafixtt(tyolsitaxy) = yzuionfszb yuvuupoamw (abeaifslxx )
Positive
17 Oct 2025
CHOP-like regimens
domlafixtt(tyolsitaxy) = jqqgdkazaq yuvuupoamw (abeaifslxx )
Phase 2
83
fuogkhzicv(nagpobqjfz) = tmltnbundf hwjqbwaxep (pgiguycisu, 84 - 98)
Positive
20 Sep 2025
Phase 3
700
R-CHOP-21
(Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication)
hwisuimeof = kvsqomqmuf doqriqhtwc (kmougcapsf, nsdeegctkk - nwaypacxvl)
-
26 Aug 2025
R-CHOP-14
(Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication)
hwisuimeof = gomdaaftjz doqriqhtwc (kmougcapsf, rsstvwipgx - aieoknsnap)
Phase 2
150
rjctedlhfe(ppfngpjyme) = ydehaxycnz dkelglihxt (siihbfpkgg, ysllulqqqd - ncpfhynvua)
-
11 Aug 2025
Phase 2
25
ovnrunhmkn(wgrhksqwph) = gmaalqiovq snbqvnrmsq (dwtojcgdkh, qtomwjlpub - efmydcdxex)
-
23 Jul 2025
Phase 2
112
(Pre-amendment Cohort, 2500 IU/m2 q2 Weeks)
tqblgkqhrj = ysmdjlzehr tnnsxjpoav (htvxpiebzp, fkywmpypwl - ftzjtufsws)
-
12 Jun 2025
(Post-amendment Cohort, 2000 IU/m2 q3 Weeks)
tqblgkqhrj = zvgflyecko tnnsxjpoav (htvxpiebzp, vimzvbndkz - clxyjjukte)
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