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Last update 08 Sep 2026
Dexrazoxane Hydrochloride
Last update 08 Sep 2026
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms dexrazoxane, Topotect, Totect + [13] |
Target |
Action inhibitors |
Mechanism Top II inhibitors(Topoisomerase II inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (26 May 1995), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Australia) |
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Structure/Sequence
Molecular FormulaC11H17ClN4O4 |
InChIKeyBIFMNMPSIYHKDN-FJXQXJEOSA-N |
CAS Registry149003-01-0 |
Related
57
Clinical Trials associated with Dexrazoxane HydrochlorideNCT07654426
A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial
NCT07502521
Dexrazoxane for the Reduction of Haemorrhagic Myocardial Infarction in STEMI: A Double-Blind, Placebo-Controlled, Sequential-Cohort Phase IIa Trial
NCT06647953
Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)
100 Clinical Results associated with Dexrazoxane Hydrochloride
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100 Translational Medicine associated with Dexrazoxane Hydrochloride
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100 Patents (Medical) associated with Dexrazoxane Hydrochloride
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984
Literatures (Medical) associated with Dexrazoxane Hydrochloride01 Aug 2026Lancet Haematology
Venetoclax in combination with cytarabine with or without idarubicin or azacitidine in children, adolescents, and young adults with relapsed or refractory acute myeloid leukaemia (VENAML): a multicentre, phase 1 expansion study
Article
Author: Daniels, Katelyn P ; Rubnitz, Jeffrey E ; Opferman, Joseph T ; Mead, Paul E ; Pounds, Stanley B ; Lacayo, Norman J ; Pui, Ching-Hon ; Mehr, Cyrus M ; Karol, Seth E ; Rees, Matthew ; Gupta, Soumyasri Das ; Wu, Huiyun ; Westover, Tamara ; Klco, Jeffery M ; Wang, Lei ; Wolf, Joshua ; Alexander, Thomas B ; Inaba, Hiroto ; Budhraja, Amit
BACKGROUND:
The prognosis for paediatric patients with relapsed or refractory acute myeloid leukaemia remains poor. Although encouraging, published paediatric data on venetoclax combined with intensive chemotherapy are scarce. We aimed to refine efficacy and toxicity estimates from the previously published dose-escalation phase of this study.
METHODS:
This multicentre, phase 1 study included two phases, an initial dose-escalation phase to identify the primary endpoint of recommended phase 2 dose (RP2D; previously reported), followed by an expansion cohort phase, the results of which are reported here. Paediatric patients (aged 2-24 years) with relapsed or refractory acute myeloid leukaemia from three US research hospitals were included. Patients had at least 5% blasts in the bone marrow by morphology or at least 1% blasts by flow cytometry. Treatment varied across cohorts. Patients received oral venetoclax 360 mg/m2 (maximum 600 mg) daily for 27 days after a 50% dose reduction on day 1 and intravenous cytarabine 1000 mg/m2 per dose every 12 h for eight doses on days 8-11 (cohort A), with intravenous idarubicin (12 mg/m2 on day 8; cohort B) and dexrazoxane or intravenous azacitidine (75 mg/m2 on days 1-7; cohort C). Here, we report results for all patients treated at the RP2D, including patients treated in the expansion cohort phase (cohort A and B) and patients in cohort C added by protocol amendment (Oct 13, 2020). This final report describes the key secondary endpoint of the rates of complete response with or without haematological recovery at the RP2D. Analyses were on the intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT03194932) and is completed.
FINDINGS:
From July 1, 2017, to July 22, 2022, 61 patients were enrolled and 44 patients were subsequently included and treated at the RP2D (21 [48%] female, 23 [52%] male; 22 [50%] in cohort A, 15 [34%] in cohort B, and seven [16%] in cohort C). The median follow-up was 5·3 years (IQR 4·2-6·3). After 1 cycle, 25 (57% [95% CI 41-72]) patients had a complete response with or without haematological recovery; 19 were negative for measurable residual disease. Common grade 3 or 4 adverse events included febrile neutropenia (23 [52%]), gastrointestinal disorders (14[32%]]) including colitis (four [9%]), and infections (11 [25%]). There were two grade 5 adverse events due to sepsis and multiorgan failure.
INTERPRETATION:
Venetoclax with high-dose cytarabine is active with acceptable safety in paediatric patients with relapsed or refractory AML. These findings support ongoing research of venetoclax with high-dose cytarabine in this population, including the randomised paediatric phase 3 trial (NCT05183035).
FUNDING:
US National Institutes of Health (NIH), American Lebanese Syrian Associated Charities (ALSAC), AbbVie, Gateway for Cancer Research.
01 Jul 2026PHYTOMEDICINE
Panax notoginseng-derived extracellular vesicles alleviate doxorubicin-induced cardiotoxicity by suppressing p53 activation
Article
Author: Wang, Tao ; Liu, Dan ; Hu, Jinpeng ; Wu, Jingwei ; Wei, Zeliang ; Jiang, Mantang ; Zhou, Qilong ; Xu, Xinrui ; Huang, Wen ; Shi, Jiayan ; Liu, Ting ; Zhang, Ying ; Xin, Guang ; Wen, Ao
BACKGROUND:
Doxorubicin (Dox) is a highly effective chemotherapeutic agent, but its clinical use is limited by cumulative cardiotoxicity. Panax notoginseng, a traditional medicinal herb, exhibits well-documented cardioprotective properties; however, the therapeutic application of its bioactive constituents is constrained by poor bioavailability and potential toxicity. Plant-derived extracellular vesicles (EVs) have emerged as natural nanocarriers facilitating cross-kingdom delivery of bioactive metabolites. In this study, we investigated whether P. notoginseng-derived EVs (PEVs) could mitigate Dox-induced cardiotoxicity (DIC) and explored the underlying mechanisms.
METHODS:
PEVs were isolated from P. notoginseng rhizomes and systematically characterized, with metabolite profiling performed by UPLC-MS. Cellular uptake, biodistribution, and cardioprotective effects were evaluated in Dox-injured cardiomyocytes and a chronic mouse model of DIC. Mechanistic insights were obtained using transcriptomic analysis, molecular docking, and biochemical assays.
RESULTS:
PEVs were stable nanosized vesicles enriched with characteristic P. notoginseng metabolites, including triterpenoid saponins and dencichine. PEVs were efficiently internalized by cardiomyocytes and preferentially accumulated in injured myocardium. Functionally, PEVs attenuated Dox-induced inflammation, apoptosis, myocardial atrophy, fibrosis, and cardiac dysfunction, with efficacy comparable to dexrazoxane. Mechanistically, transcriptomic and molecular analysis identified p53 as a central regulatory target. PEVs-derived metabolites targeted the p53 DNA-binding domain, suppressing p53 phosphorylation and transcriptional activation of pro-apoptotic and inflammatory genes. Notably, p53 activation attenuated PEVs-mediated protection, whereas p53 inhibition or silencing abolished additional protective effects, indicating a p53-dependent mechanism.
CONCLUSION:
PEVs protect against DIC by delivering bioactive metabolites to injured myocardium and inhibiting p53-driven oxidative, inflammatory, and apoptotic pathways, highlighting their potential as a phytomedicine-based cardioprotective strategy.
01 Jun 2026Cardiovascular Toxicology
Doxorubicin-Induced Cardiotoxicity in Breast Cancer: Mechanistic Pathways, Pharmacogenomic Modifiers, and Translational Strategies
Review
Author: Cheng, Yu-Che ; Lin, Shih-Chang ; Kuok, Chi-Tong ; Guo, Jiun-Wen ; Huang, Chen-Yu ; Lee, Hao-Wei
Doxorubicin, a prototypical anthracycline, remains an important component of breast cancer therapy, although its use has declined with the availability of effective non-anthracycline regimens and is increasingly restricted to selected high-risk settings. At the same time, anthracyclines continue to serve as first-line therapy for multiple malignancies, including lymphomas, leukemias, and sarcomas, sustaining the broad clinical relevance of anthracycline-associated cardiotoxicity. This timely review synthesizes mechanistic, pharmacogenomic, and translational evidence on doxorubicin-induced cardiovascular toxicity. We highlight the interplay of DNA intercalation, topoisomerase II poisoning, redox cycling, mitochondrial dysfunction, and lipid metabolism as drivers of both anticancer efficacy and myocardial injury. Pharmacogenomic variants such as RARG, SLC28A3, and SLC22A3 (OCT3) modify individual susceptibility, offering investigational, genotype-informed avenues for cardioprotection. Emerging biomarkers-including troponins, sphingolipids, cell-free DNA, and immune signatures-show promise for early detection of cardiac injury. In parallel, tumor-intrinsic and microenvironmental mechanisms contribute to doxorubicin resistance, underscoring the need for integrated strategies that address efficacy and toxicity concurrently. Translational advances include established cardioprotective approaches such as dexrazoxane and liposomal formulations, alongside investigational strategies-including SGLT2 inhibitors, OCT3 blockade, and RARG agonists-that require prospective validation. Complementary efforts to overcome resistance encompass nanomedicine-based delivery, STAT3 inhibition, and RNA-directed therapeutics. By converging molecular mechanisms, pharmacogenomic insights, and biomarker discovery, this review outlines precision strategies to sustain doxorubicin benefit while minimizing cardiovascular harm.
5
News (Medical) associated with Dexrazoxane Hydrochloride11 Aug 2023
AcquisitionLicense out/in
10 Aug 2023
AcquisitionRadiation Therapy
100 Deals associated with Dexrazoxane Hydrochloride
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D07807 | Dexrazoxane Hydrochloride |
R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Extravasation of Diagnostic and Therapeutic Materials | European Union | 27 Jul 2006 | |
| Extravasation of Diagnostic and Therapeutic Materials | Iceland | 27 Jul 2006 | |
| Extravasation of Diagnostic and Therapeutic Materials | Liechtenstein | 27 Jul 2006 | |
| Extravasation of Diagnostic and Therapeutic Materials | Norway | 27 Jul 2006 | |
| Cytoprotective Agent | China | 29 May 2006 | |
| Cardiomyopathies | United States | 26 May 1995 | |
| Metastatic breast cancer | United States | 26 May 1995 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hemorrhage | Phase 3 | Denmark | 01 Apr 2002 | |
| Hemorrhage | Phase 3 | Germany | 01 Apr 2002 | |
| Hemorrhage | Phase 3 | Italy | 01 Apr 2002 | |
| Hemorrhage | Phase 3 | Netherlands | 01 Apr 2002 | |
| Hemorrhage | Phase 3 | Poland | 01 Apr 2002 | |
| Bronchitis | Phase 3 | Denmark | 01 Jun 2001 | |
| Cysts | Phase 2 | Spain | 21 Oct 2005 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 1 | 25 | (Dexrazoxane 100mg/m2) | pjslqqfcpn = hvznqgptus neempdjyok (albjgslaxz, svcnegzgpt - tyhofuzwzd) View more | - | 12 Jun 2025 | ||
(Dexrazoxane 200mg/m2) | pjslqqfcpn = iglveojplv neempdjyok (albjgslaxz, celmadfwyr - kspovccyvt) View more | ||||||
Phase 2 | 73 | (Arm 1: Doxorubicin and Upfront Dexrazoxane) | nlubllxsfh(ajustkyflm) = wijtkiptph hkjhsyifcx (abecazfsag, yfmwxofcyl - kglajhltor) View more | - | 07 Nov 2023 | ||
(Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)) | nrakrvcmum = fehakzozyb esykyjjfbf (bxcidarpcu, iedjfdpvaf - phtizjmfkx) View more | ||||||
Not Applicable | 263 | PEG G-CSF | yhllgrwxoj(wkzxutkslg) = manonrtuie hxctmxeshb (qyhbtofzvu ) View more | - | 03 Dec 2022 | ||
Non-PEG G-CSF | yhllgrwxoj(wkzxutkslg) = lcfhlumeat hxctmxeshb (qyhbtofzvu ) View more | ||||||
Not Applicable | - | 1,308 | utdqunipuf(zcyphgerou): HR = 1.07 (95% CI, 0.78 - 1.47) View more | - | 15 Feb 2022 | ||
Phase 2 | 46 | (Arm A: VACdxr With ImmTher) | zinkcynght(antnlxoada) = usgcttngck zxpjavemhr (hgneedaijb, slrubmssev - ipnmixkxxv) View more | - | 29 Jan 2020 | ||
(Arm B: VACdxr) | zinkcynght(antnlxoada) = xrsdbbybdt zxpjavemhr (hgneedaijb, qmjuyagtka - efcmfmprwx) View more | ||||||
Phase 1 | 1 | ihakhlvsuz = ajhxogyabh sdiacuvlok (xctrgqalkz, ffwzmihgrp - aibdpedppp) View more | - | 19 Feb 2019 | |||
Not Applicable | 1,014 | avuinyzwrw(iovuokugby) = dhtrisnnpj ytfsytmxgv (shsawzsmoz ) View more | Positive | 01 Jun 2018 | |||
No Dexrazoxane | avuinyzwrw(iovuokugby) = dgymicnvsv ytfsytmxgv (shsawzsmoz ) View more | ||||||
Phase 1/2 | 2 | vmtqfveaea = vnapbplzsz kndlwpoyom (elgqkdhsug, ewgjmwhrds - cfibsmhaps) View more | - | 13 Mar 2015 | |||
Not Applicable | 7 | (Outpatient Chemotherapy) | snopwshbjl(lqfzqjchwi) = sqhzxztqoa snnrwuhiet (pclurhytwv, giutxkivtc - mfkccurdgy) View more | - | 10 Sep 2014 | ||
Surgery+Dexrazoxane+Mesna+Leucovorin+Doxorubicin+ifosfamide+Gemcitabine+Sargramostim+Methotrexate+cisplatin (Additional Risk-Adapted Outpatient Chemotherapy) | snopwshbjl(lqfzqjchwi) = mvurtzqcrf snnrwuhiet (pclurhytwv, qloqvqzffv - xbbdrdkjds) View more | ||||||
Phase 2 | 7 | neoadjuvant therapy+dexrazoxane hydrochloride+filgrastim+doxorubicin hydrochloride+ifosfamide+irinotecan hydrochloride | xylzkqwwig = xmldoodekx twlvflsrfv (rgpsyjsvdj, dyxgzjuhoo - ijjodvluym) View more | - | 28 Aug 2014 |
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