Drugs / Dexrazoxane
Dexrazoxane
also known as
Dexrazoxane hydrochloride · ADR-529 · ADR-529 HYDROCHLORIDE · Cardioxan · Cardioxane · Cardioxane (Dexrazoxane) · Dexrazoxane for Injection · Dexrazoxane hcl · +10 more
Small molecule targets TOP2B
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TOTECT | — | 2020-11-02 | fda.gov ↗ |
| Filed | Japan (PMDA) | — | anthracycline extravasation tissue injury | 2013-01-30 | “アントラサイクリン系抗悪性腫瘍剤の静脈内投与時の血管外漏出による組織障害を治療する薬剤「デクスラゾキサン」（一般名）について、このたび製造販売承認申請を行いました” kissei.co.jp ↗ |
| Approved | EU (EMA) | Savene | — | 2006-07-27 | europa.eu ↗ |
| Label expansion | US (FDA) | ZINECARD | — | 2002-10-31 | fda.gov ↗ |
| Approved | US (FDA) | ZINECARD | — | 1995-05-26 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03930680 | Sep 2021 → Jun 2024 | — | University of Arkansas | Completed | No outcome recorded |
| Phase 1 | NCT04997291 | Apr → Oct 2021 | congenital heart disease | University of Texas at Austin | Unknown | No outcome recorded |
| Phase 1 | NCT02519335 | Sep 2014 → Mar 2017 | congenital heart disease | Medical City Children's Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT00039481 | Nov 2002 → Oct 2005 | chemotherapy-induced toxicity, childhood malignant neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00550901 | Feb 2001 → Jul 2007 | cancer of unknown primary site | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01596088 | ? → Jan 2014 | chemotherapy-induced toxicity | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07654426 | Oct 2026 → Dec 2030 expected | chemotherapy-induced toxicity, diffuse large B-cell lymphoma | Beth Israel Deaconess Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07502521 | Aug 2025 → Feb 2026 | acute myocardial infarction | Rohan Dharmakumar | Completed | No outcome recorded |
| Phase 2 | NCT03589729 | Sep 2018 → Dec 2027 expected | Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, myelodysplastic syndrome, myeloid sarcoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT02584309 | Feb 2016 → Jul 2022 | angiosarcoma, epithelioid sarcoma, fibrosarcoma, leiomyosarcoma +5 | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01627938 | Apr 2012 → Apr 2015 | multiple sclerosis | PD Dr. Andrew Chan | Unknown | No outcome recorded |
| Phase 2 | NCT00955890 | Jun 2009 → Feb 2012 | breast cancer | Fudan University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00003667 | Sep 1998 → Aug 2000 | sarcoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00001335 | Apr 1993 → Jan 2002 | Ewing sarcoma, neuroblastoma, rhabdomyosarcoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00548704 | Apr 2002 → Aug 2005 | — | Valerio Therapeutics | Completed | No outcome recorded |
| Phase 2/3 | NCT00548561 | Jun 2001 → Jul 2003 | chemotherapy-induced toxicity | Valerio Therapeutics | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT06220032 | Aug 2024 → Dec 2028 expected | diffuse large B-cell lymphoma | HOVON Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT03007147 | Aug 2017 → Jun 2026 overdue | B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, mixed phenotype acute leukemia | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00016276 | May 2001 → Mar 2005 | female breast carcinoma, inflammatory breast carcinoma, poisoning | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 3 | NCT00003937 | Sep 1999 → Mar 2004 | chemotherapy-induced toxicity, sarcoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00005578 | Mar 1997 → Oct 2004 | chemotherapy-induced toxicity, lymphoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00002827 | Oct 1996 → Oct 2004 | chemotherapy-induced toxicity, lymphoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00165087 | Jan 1996 → Sep 2006 | childhood acute lymphoblastic leukemia | Dana-Farber Cancer Institute | Terminated | Met primary |
| Comparator or background therapy32 trials | ||||||
| Phase 1 | NCT05858710 Background | Apr 2023 → Jan 2025 | soft tissue sarcoma | Thermosome GmbH | Completed | No outcome recorded |
| Phase 1 | NCT05292664 Background | Mar 2023 → Jul 2028 expected | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia, lymphoblastic lymphoma, myelodysplastic syndrome +1 | Andrew E. Place, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT01606878 Background | Apr 2013 → Dec 2018 | anaplastic large cell lymphoma, childhood malignant neoplasm, neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT01523977 Background | Nov 2011 → Jan 2017 | acute lymphoblastic leukemia | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01258634 Background | Jul 2010 → Nov 2011 | osteosarcoma, respiratory system cancer | University of Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00933985 Background | Jun 2009 → Apr 2013 | Burkitt lymphoma, Hodgkins lymphoma, acute undifferentiated leukemia, anaplastic large cell lymphoma +15 | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT00928200 Background | Apr 2009 → Jun 2010 | acute lymphoblastic leukemia | Therapeutic Advances in Childhood Leukemia Consortium | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00742924 Background | Aug 2008 → Apr 2012 | sarcoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1/2 | NCT00098839 Background | Feb 2005 → Apr 2011 | childhood acute lymphoblastic leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT06262438 Background | Feb 2024 → Jun 2028 expected | childhood acute myeloid leukemia | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT03698227 Background | Nov 2018 → Jun 2020 | soft tissue sarcoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Terminated | No outcome recorded |
| Phase 2 | NCT03164057 Background | Jun 2017 → Sep 2025 overdue | acute myeloid leukemia, myelodysplastic syndrome | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01871766 Background | Dec 2013 → Dec 2026 expected | rhabdomyosarcoma | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01864109 Background | May 2013 → May 2027 expected | Ewing sarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01696669 Background | Mar 2010 → Dec 2017 | Ewing sarcoma | Spanish Group for Research in Sarcomas | Completed | No outcome recorded |
| Phase 2 | NCT00077285 Background | Oct 2003 → Oct 2027 expected | sarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00084838 Background | Feb 2003 → Feb 2008 | central nervous system cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00544778 Background | Aug 2001 → Nov 2011 | sarcoma | City of Hope Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT00019864 Background | Mar 2000 → Dec 2006 | chemotherapy-induced toxicity, sarcoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT00038142 Background | Nov 1997 → Mar 2016 | Ewing sarcoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06647953 Background | Mar 2025 → Mar 2029 expected | pleuropulmonary blastoma | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT04478292 Background | Mar 2021 → Mar 2027 expected | hepatoblastoma | Shanghai Children's Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT04293562 Background | Jul 2020 → Jun 2029 expected | acute myeloid leukemia | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT03126916 Background | May 2018 → Sep 2030 expected | neuroblastoma, nodular ganglioneuroblastoma | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT03020030 Background | Mar 2017 → Nov 2026 expected | childhood acute lymphoblastic leukemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01231906 Background | Nov 2010 → Mar 2020 | extraskeletal Ewing sarcoma, peripheral primitive neuroectodermal tumor of bone, peripheral primitive neuroectodermal tumor of soft tissues | Children's Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00980460 Background | Sep 2009 → Jun 2020 | hepatoblastoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 3 | NCT00334867 Background | Dec 2005 → Jan 2006 | sarcoma | Children's Oncology Group | Withdrawn | No outcome recorded |
| Phase 3 | NCT00400946 Background | Apr 2005 → Aug 2014 | leukemia, poisoning | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 3 | NCT01230983 Comparator | Jun 1996 → Sep 2001 | acute leukemia, chemotherapy-induced toxicity, lymphoma | Children's Oncology Group | Completed | No outcome recorded |
| — | NCT00673179 Background | May 2008 → Nov 2010 | osteosarcoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00410488 Comparator | Dec 2006 → Jun 2011 | sarcoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2014-01-17 | Kissei Pharmaceutical Co., Ltd. | Regulatory アントラサイクリン系抗悪性腫瘍剤の血管外漏出治療薬 「サビーン®点滴静注用500mg」 製造販売承認取得のお知らせ kissei.co.jp ↗
キッセイ薬品工業株式会社（本社：長野県松本市、代表取締役社長：神澤陸雄）は、本日、アントラサイクリン系抗悪性腫瘍剤の血管外漏出による組織障害を抑制する治療薬「サビーン ® 点滴静注用500mg」（一般名：デクスラゾキサン、以下本剤）の製造販売承認を取得しましたのでお知らせ致します。 |
| 2013-01-30 | Kissei Pharmaceutical Co., Ltd. | Regulatory アントラサイクリン系抗悪性腫瘍剤血管外漏出治療剤「デクスラゾキサン」 国内における製造販売承認申請のお知らせ kissei.co.jp ↗
キッセイ薬品工業株式会社（本社：長野県松本市、代表取締役社長：神澤陸雄）は、アントラサイクリン系抗悪性腫瘍剤の静脈内投与時の血管外漏出による組織障害を治療する薬剤「デクスラゾキサン」（一般名）について、このたび製造販売承認申請を行いましたのでお知らせ致します。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-01-17 | Kissei Pharmaceutical Co., Ltd. | アントラサイクリン系抗悪性腫瘍剤の血管外漏出治療薬 「サビーン®点滴静注用500mg」 製造販売承認取得のお知らせ kissei.co.jp ↗ |
| 2013-01-30 | Kissei Pharmaceutical Co., Ltd. | アントラサイクリン系抗悪性腫瘍剤血管外漏出治療剤「デクスラゾキサン」 国内における製造販売承認申請のお知らせ kissei.co.jp ↗ |
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dexrazoxane | “* Dexrazoxane: administered at a dose of 10:1, before doxorubicin only in adults.” NCT01696669 ↗44“(Dexrazoxane : 300 mg/m2/dose Day 1 and 2, where is available)” NCT04478292 ↗ “Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin)” NCT00038142 ↗ |
| Known as | ADR-529 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00001335 ↗ |
| Known as | ADR-529 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | Cardioxan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | Cardioxane | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | Cardioxane (Dexrazoxane) | “Cardioxane® (Dexrazoxane)” NCT01627938 ↗ |
| Known as | Dexrazoxane for Injection | “Dexrazoxane for Injection” NCT00955890 ↗ |
| Known as | Dexrazoxane hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | Dexrazoxane hydrochloride | “doxorubicin hydrochloride and dexrazoxane hydrochloride IV continuously over 96 hours.” NCT00544778 ↗13“dexrazoxane hydrochloride IV continuously over 96 hours beginning on day 1” NCT00550901 ↗ “Drug: Dexrazoxane hydrochloride” NCT00955890 ↗ “Drug: dexrazoxane hydrochloride” NCT00003937 ↗ “Drug: dexrazoxane hydrochloride” NCT00077285 ↗ “Drug: dexrazoxane hydrochloride” NCT00002827 ↗ |
| Known as | dexrazoxane injection | “dexrazoxane injection” NCT00955890 ↗ |
| Known as | Dexrazoxano | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | ICRF-187 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | ICRF-187 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | KDX-0811 | “A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents” NCT01596088 ↗ |
| Known as | NSC-169780 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738 ↗ |
| Known as | Savene | “BACKGROUND: The purpose of this study was to assess the efficacy and tolerability of i.v. dexrazoxane [Savene (EU), Totect (US)] as acute antidote in biopsy-verified...” PMID 17185744 ↗ Dec 2006 |
| Known as | Topotect | “A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines” NCT00548704 ↗ |
| Known as | Totect | “BACKGROUND: The purpose of this study was to assess the efficacy and tolerability of i.v. dexrazoxane [Savene (EU), Totect (US)] as acute antidote in biopsy-verified...” PMID 17185744 ↗ Dec 2006 |
| Known as | Zinecard | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00410488 ↗ |
| Action | Inhibit | “Topoisomerase II Inhibitor” NCT07654426 ↗ |
| Modality | Small molecule | — CHEMBL1738 ↗ |
| Route | Intravenous | “Given IV” NCT00002827 ↗ |
| Target | TOP2B | “dexrazoxane is also a catalytic inhibitor of topoisomerase 2b (Top2b), a key mediator of doxorubicin toxicity.” PMID 40317097 ↗ May 2025 |