This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB.
Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor.
The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.

Start Date21 Mar 2025

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT06220032

/ RecruitingPhase 3IIT

ANTICIPATE: Prevention of ANThracycline-Induced Cardiac Dysfunction by Dexrazoxane In PATients With diffusE Large B-cell Lymphoma: a Phase III National Multicenter Prospective Randomized Open-label Trial

Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity. Thereby patients treated for this malignancy are at double the risk of developing symptomatic heart failure / cardiomyopathy when compared to the general population. This corresponds to a cumulative incidence of 5-10% within 5-years after receiving R-CHOP. In the elderly, an incidence of 26% has been reported after 8-years of follow-up. Among patients who die in complete remission, heart failure has been described to be one of the most important causes of death. ANTICIPATE aims to evaluate if dexrazoxane can prevent AICD in DLBCL patients and identify those at highest risk of AICD. Of all patients treated with anthracyclines in a first-line setting, DLBCL patients were chosen for this trial for two primary reasons. Firstly, these patients have a favourable oncological prognosis with a 5-year relative survival in the Netherlands of 64-78% in those aged 18-74 years increasing the importance of preventing long-term toxicity. Secondly, the cumulative anthracycline dose used for the treatment of DLBCL is higher than the dose used in breast cancer. The cumulative anthracycline dose is the most important risk factor for AICD known.

Start Date15 Aug 2024

Sponsor / Collaborator

Hemato-Oncologie voor Volwassenen Nederland

[+1]

100 Clinical Results associated with Dexrazoxane Hydrochloride

100 Translational Medicine associated with Dexrazoxane Hydrochloride

100 Patents (Medical) associated with Dexrazoxane Hydrochloride

1,212

Literatures (Medical) associated with Dexrazoxane Hydrochloride

01 Dec 2025·Natural Products and Bioprospecting

Design, synthesis and biological evaluation of buthutin derivatives as cardioprotective agents

Article

Author: Xu, Yun-Sheng ; Wang, Li-Ning ; Wang, Fa-Qi ; Shao, Chen-Yue ; Yang, Shu-Han ; Liu, Yu-Ming ; Gou, Xiang-Bo ; Hua, Xin-Hao ; Liu, Yuan

AbstractNatural products are the important sources in cardiovascular drug development. In this study, twenty-nine buthutin derivatives were designed, synthesized, and evaluated for their NHE-1 inhibition and protective effects on cardiomyocyte injury. The structure of the newly synthesized compounds had been confirmed by 1H-NMR, 13C-NMR, and HR-ESI-MS spectra. Among all target compounds at 1 μM, compounds 9d, 9f, 9k, 9m, and 9n, with a protection ratio exceeding 30%, exerted stronger protective effects on H9c2 cardiomyocyte than positive control dexrazoxane and buthutin A. Meanwhile, compounds 9k, 9m, and 9o showed the significant NHE-1 inhibitory activities on H9c2 cardiomyocyte, all with a dpHi/min value less than 0.23. What is more, compounds 9k, 9m, 9o and buthutin A all exhibited the specificity on NHE-1 inhibition. Molecular modelling studies suggested the ability of compounds 9m and 9o to establish interactions with three hydrogen bonds to Asp267 and Glu346 of NHE-1, but also the ability with much lower CDOCKER energies than positive control cariporide and buthutin A. The structure–activity relationship (SAR) studies suggested that the presences of amide group, four-carbon linker, and para hydroxyl benzene ring were advantageous pharmacophores for above two pharmacological actions. This research would open new avenues for developing amide-guanidine-based cardioprotective agents.Graphical Abstract

01 Jun 2025·Phytomedicine

Erianin alleviates doxorubicin-induced cardiotoxicity by activating the Keap1-Nrf2 signaling pathway

Article

Author: Li, Huimin ; Li, Ming ; Zhao, Yuan ; Pang, Jianyu ; Kang, Shiyao ; Dan, Juhua ; Sheng, Miaomiao

BACKGROUNDDoxorubicin (DOX) has significant toxic side effects on cardiomyocytes, and existing preventive drug dexrazoxane has serious side effects. Therefore, in-depth research on drugs that can enhance the antitumor effect of DOX and simultaneously reduce its cardiotoxicity is of crucial significance. Our study explored the regulatory role of Erianin in DOX-induced cardiotoxicity and the specific molecular mechanism.METHODSIn this study, we constructed a myocardial injury model in mice with DOX. The toxic side effects of DOX on the organism were determined by recording the weight changes of the mice and calculating the spleen index and heart-tibia ratio of the mice. The degree of myocardial injury in mice was evaluated by methods such as echocardiography and Sirius red staining. Further in vivo experiments were conducted to verify whether the silencing of Nrf2 could block the protective effect of Erianin on myocardial cells.RESULTSWe found Erianin significantly alleviated DOX-induced cardiomyocyte injury (p < 0.0001), increased heart tissue pumping efficiency and contractility (p < 0.001), and reduced myocardial cell fibrosis. Mechanism study showed that Erianin can bind to Keap1, promote its ubiquitination and autophagic degradation, increase the acetylation of lysine 599 site in Nrf2 protein, and activate the antioxidant stress response.CONCLUSIONSTaken together, our study had for the first time elucidated the molecular mechanism by which Erianin alleviated DOX-induced myocardial injury by activating the Keap1-Nrf2 signaling pathway. It provides a theoretical basis for the development of Erianin as a potential protective drug for DOX-induced cardiotoxicity. It has very important clinical application and translational value.

01 Apr 2025·Reproduction

Mechanisms of chemotherapy-induced oocyte death through activation of TAp63α

Article

Author: Kirchhof, Anja ; Tuppi, Marcel ; Dikic, Ivan ; Hofmann, Antonia ; Schäfer, Birgit ; Dotsch, Volker ; Gutfreund, Niklas ; Klinger, Francesca Gioia

Premature ovarian insufficiency (POI) is a severe side effect of classical chemotherapy and radiotherapy in treatment of female cancer patients of reproductive age. The molecular mechanisms underlying POI are diverse, ranging from altered hormone levels to decimated resting oocyte reserve by apoptosis or elevated recruitment. The p53-homolog TAp63α emerged as the key protein regulating apoptosis following DNA damage in primary oocytes. In this study we monitored the ovotoxicity of widely used chemotherapeutic agents utilizing a GFP-c-Kit transgenic mouse model, the involvement of active TAp63α and the mechanism of action leading to its activation. Our studies show that alkylating agents as well as topoisomerase II poisons are potent activators of TAp63α by directly inducing DNA damage. Oxidative stress as well as DNA-intercalation were not sufficient to trigger TAp63α activation despite showing a strong general ovotoxicity. These results are in agreement with several previous investigations that have demonstrated that DNA double strand breaks are the most effective way to initiate apoptosis in primordial follicles. The widely used catalytic topoisomerase II inhibitor ICRF-187 were able to prevent doxorubicin-mediated activation of TAp63α by the topoisomerase II poisons doxorubicin

News (Medical) associated with Dexrazoxane Hydrochloride

11 Aug 2023

·www.pharmaceutical-technology.com

Clinigen clears out cancer therapies in line with latest growth strategy

Akosua Mireku @AkosuaMireku1 This action follows Clinigen’s January 2023 sale of its kidney cancer treatment Proleukin (aldesleukin) to Iovance Biotherapeutics. Credit: Volodymyr Maksymchuk via Shutterstock. UK-headquartered Clinigen announced the divestment of global rights for four of its cancer therapies from its portfolio, as per a 10 August press release. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The company gave away the rights of Cardioxane, Savene, Totect and Ethyol (amifostine), as Clinigen shifts its pharmaceutical strategy. The first three drugs use dexrazoxane to treat cardiotoxicity caused by cancer drugs while Ethyol is used to correct the effects of cancer treatment with cisplatin or radiation. Recommended Reports Reports Global Hematological Cancer (Blood Cancer) Therapy Market to 2027 - Comprehensive Overview of Mar... GlobalData Reports Hypopharyngeal Cancer Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Pla... GlobalData View all Companies Intelligence Iovance Biotherapeutics Inc Clinigen Inc CNX Therapeutics Ltd Drug Safety Navigator, LLC Lamda Laboratories SA View all Clinigen announced that the four drugs will join CNX Therapeutics’ pharmaceutical portfolio. Based in the UK, CNX Therapeutics commercialises and distributes pharmaceuticals in 40 countries globally. According to its website, the biotech is “seeking to expand its product portfolio in Europe and selected global markets.” This action follows Clinigen’s January 2023 sale of its kidney cancer treatment Proleukin (aldesleukin) to Iovance Biotherapeutics . This deal included an upfront payment of £166.7m ($211.8m), a milestone-based payment of £41.7m ($53m) upon first approval of lifileucel in advanced melanoma, and double-digit Proleukin global sales royalties from Iovance to Clinigen. Proleukin uses interleukin-2 to induce T cell-mediated tumour regression in advanced melanoma. CNX is developing lifileucel as a cell therapy for various cancers. The US Food and Drug Administration accepted a biologics licence application (BLA) for lifileucel in May 2023. In a press release , Clinigen CEO Jerome Charton said: “These medicines have been integral to Clinigen, but as we refocus our efforts, it is crucial to align our offerings with our core strategy and I’m delighted that CNX Therapeutics will be acquiring these brands.” Clinigen’s recent divestments follow others to strengthen its existing capabilities. Last year, the company acquired Drug Safety Navigator to improve its pharmacovigilance capabilities. It also expanded its US site due to reported growth in demand for its clinical supplies management services. This included the opening of new satellite sites in North Dakota and Pennsylvania. This year, Clinigen also sold its innovative contract development business Lamda Laboratories to Germany-based Adragos Pharma. Before this divestment, Lamda acted as Clinigen’s sole development centre. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

AcquisitionLicense out/in

10 Aug 2023

·www.biospace.com

Clinigen divests global rights to four cancer support therapies to CNX Therapeutics

Clinigendivests global rights to four cancer support therapies to CNX Therapeutics Clinigen Limited (‘Clinigen’), the global pharmaceutical services company, has completed the divestment of four cancer supportive care products from its established brands portfolio to CNX Therapeutics, a speciality pharmaceutical company with a focus on improving access to medicines that are critical to the well-being of patients. Under the terms of the agreement, (the financial terms for which are not being disclosed), Clinigen will divest four medicines; Cardioxane®, Savene®, Totect® and Ethyol®, all of which help mitigate the side effects patients may experience when treated with other cancer therapies. Cardioxane®, used in adults with advanced or metastatic breast cancer to prevent long-term harmful effects on the heart caused by treatment with certain anthracyclines. Savene®, used to treat anthracycline extravasation in adults, a rare condition that can impact cancer patients. Totect®, used for the treatment of anthracycline extravasation as well as for preventing cardiomyopathy associated with doxorubicin in women with metastatic breast cancer. Ethyol®, used to reduce the cumulative renal toxicity of cisplatin in patients with advanced ovarian cancer and for reduction of the toxic effects of radiation on normal oral tissues in patients with head and neck cancer. The divestment is the next step for Clinigen in its strategy of increasing focus on those areas of the pharmaceutical services market where it has a growing and sustainable competitive advantage, increasing its exposure to high value, niche services and divesting units and products which no longer support that goal. Earlier this year Clinigen agreed the sale of Proleukin® to Iovance Biotherapeutics, and later divested Lamda Laboratories SA, its European-based innovative contract development business, to Adragos Pharma GmbH. In late 2022, Clinigen acquired Drug Safety Navigator (‘DSN’), a specialist pharmacovigilance service provider based in the US, adding vital pharmacovigilance capabilities to its pharmaceutical services offering. Jerome Charton,Chief Executive Officer at Clinigen commented, “This divestment marks another milestone in Clinigen’s continued strategic evolution towards providing high-value services to the pharmaceutical and biotech sectors. These medicines have been integral to Clinigen, but as we refocus our efforts, it is crucial to align our offerings with our core strategy and I’m delighted that CNX Therapeutics will be acquiring these brands.” CNX Therapeutics’ CEO, Guy Clark said, “The addition of these products to the CNX portfolio strengthens our position as a provider of critically-important hospital injectable products, and demonstrates our commitment to improving the lives of patients by ensuring the supply of essential medicines. We recognise the great value of these products to prescribers and patients, and are very pleased to partner with Clinigen to transition this important portfolio of products and to ensure ongoing continuity of supply.” Greenhill & Co are acting as financial advisor to Clinigen. – Ends – Contact details: Consilium Strategic Communications Jessica Hodgson / Susan Stuart / Melissa Gardiner Tel: +44 (0) 20 3709 5700Clinigen@consilium-comms.com Notes to Editors About Clinigen Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,200 employees across five continents in 15 countries, and provides access in more than 120 countries every year. For more information on Clinigen, please visit: About CNX Therapeutics CNX Therapeutics is a speciality pharmaceutical company committed to improving the lives of patients by providing access to essential medicines. They commercialise and distribute a portfolio of pharmaceuticals for neurological, psychiatric and hospital emergencies in 40 countries worldwide, both directly and through strategic partnerships. CNX Therapeutics’ vision is to become a recognised partner of choice through their commercial excellence, patient focus and presence across Europe. They aim to have a pioneering and industry-leading approach to their Environment, Social and Governance (ESG) goals, which forms a key element of the organisation’s mission and objectives. For more information on CNX Therapeutics, please visit:

AcquisitionRadiation Therapy

13 Feb 2019

·www.biospace.com

Clinigen Group To Acquire U.S. Rights to Proleukin From Novartis

London-based Clinigen Group pc will now have full rights to Proleukin (aldesleukin, human recombinant interleukin-2). This morning, the U.K.-based pharmaceutical and services company struck a deal with Novartis to acquire the U.S. rights to the metastatic renal cell carcinoma treatment. London-based Clinigen Group pc will have full rights to Proleukin (aldesleukin, human recombinant interleukin-2). This morning, the U.K.-based pharmaceutical and services company struck a deal with Novartis to acquire the U.S. rights to the metastatic renal cell carcinoma treatment. Clinigen signed an agreement with the Swiss pharma giant to acquire the U.S. rights for up to $210 million in cash. The payment consisted of a $120 million upfront payment, a deferred payment of $60 million and future sales-related milestones that could total $30 million. Clinigen already owns the rights to Proleukin outside the US, which it acquired in July 2018. With the deal, Clinigen will be the exclusive global owner of the licensed version of this drug, which is being used in multiple drug studies across different disease areas. The company said Proleukin has the potential to become an integral part of cancer combination therapies. When the company acquired the global rights to Proleukin over the summer, Clinigen said it planned to attempt to revitalize sales of the medicine by working with health care professionals to “ensure its benefit to patients is well understood and by making the medicine available to those who need it through the Group’s global distribution network for both licensed and unlicensed supply.” Shaun Chilton, group chief executive officer at Clinigen, said the U.S. rights to Proleukin will be significant for the whole of the company, not just its Commercial Medicines division. Chilton noted that the acquisition will allow the Clinigen Group to expand its footprint in the U.S. market. “As part of Commercial Medicines, Proleukin is an excellent fit within our oncology and infectious disease medicines as well as diversifying our wider portfolio - it will be the largest product in the portfolio in terms of current sales. The product has significant potential for revitalization, which will provide further breadth and diversity to the portfolio and material increases in revenues,” Chilton said in a statement. In its announcement this morning, Clinigen said Proleukin further diversifies its Commercial Medicines portfolio of niche hospital-only and critical care products. That division also has the U.S. rights to other assets, including Foscavir, Ethyol and Totect. Commercial rights for those three drugs have been licensed to Pfizer (Foscavir) and Cumberland Pharmaceuticals (Ethyol and Totect), Clinigen said. Proleukin generated $60 million in revenue in the United States for the year leading up to June 30, 2018, Clinigen said, citing data from IQVIA. The company said gross profit margin is expected to be similar to other specialty medicines within its Commercial Medicines division. The deal with Novartis follows Clinigen’s September 2018 deals to acquire CSM and iQone Healthcare , which strengthened the company’s position in the European market.

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100 Deals associated with Dexrazoxane Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D07807	Dexrazoxane Hydrochloride	V03AF02	DB00380

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Metastatic breast cancer	Australia	Reach Pharmaceuticals Pty Ltd.	24 Mar 2025
Extravasation of Diagnostic and Therapeutic Materials	European Union	CNX Therapeutics Ltd.	27 Jul 2006
Extravasation of Diagnostic and Therapeutic Materials	Iceland	CNX Therapeutics Ltd.	27 Jul 2006
Extravasation of Diagnostic and Therapeutic Materials	Norway	CNX Therapeutics Ltd.	27 Jul 2006
Extravasation of Diagnostic and Therapeutic Materials	Liechtenstein	CNX Therapeutics Ltd.	27 Jul 2006
Cytoprotective Agent	China	Nanjing Hairun Pharmaceutical Co Ltd.	29 May 2006

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Extravasation of Diagnostic and Therapeutic Materials	Discovery	United States	Clinigen Ltd.	06 Sep 2007
Hemorrhage	Discovery	Poland	Valerio Therapeutics SA	01 Apr 2002
Hemorrhage	Discovery	Denmark	Valerio Therapeutics SA	01 Apr 2002
Hemorrhage	Discovery	Italy	Valerio Therapeutics SA	01 Apr 2002
Hemorrhage	Discovery	Germany	Valerio Therapeutics SA	01 Apr 2002
Hemorrhage	Discovery	Netherlands	Valerio Therapeutics SA	01 Apr 2002
Bronchitis	Discovery	Denmark	Valerio Therapeutics SA	01 Jun 2001

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Acute Myeloid Leukemia	-	Dexrazoxane	lkkkhnrqnu(bhqrdnytvz) = tiuvsejzmr djkqlgdcxk (qmbfkgzoqk ) View more	-	07 Dec 2024
				Non-initiators of Dexrazoxane	lkkkhnrqnu(bhqrdnytvz) = ejsiehtvlu djkqlgdcxk (qmbfkgzoqk ) View more
ASCO2023	Not Applicable	Neoplasms	142	Anthracycline + Dexrazoxane	(nsuigivyqp) = rexlasursp odqnlwywif (qifjfxvpin )	Positive	31 May 2023
				Anthracycline only	(nsuigivyqp) = pyjgzklwqe odqnlwywif (qifjfxvpin ) View more
NCT03786783 (ANBL17P1, CTgov)	Phase 2	High Risk Neuroblastoma \| Ganglioneuroblastoma	42	External Beam Radiation Therapy+Etoposide+Carboplatin+Isotretinoin+Sargramostim+Topotecan+Dexrazoxane+Doxorubicin+Dinutuximab+cyclophosphamide+Melphalan+cisplatin+Vincristine+Thiotepa	fvtcrldsax(hmbjqpmybn) = cvmksuwhzt wmwlnwtpzs (imtvkvarbt, hjllzovpov - acttmzneew) View more	-	14 Mar 2023
NCT00980460 (AHEP0731, CTgov)	Phase 3	Hepatoblastoma \| Liver Cancer	236	Therapeutic Conventional Surgery (Very Low-risk Group)	(yhvgskjoyi) = rgcohhnbai vpptsjaryh (cksrjmtqfq, hxzxplbwxa - vunebzspou) View more	-	28 Dec 2021
				Therapeutic Conventional Surgery+cisplatin+Vincristine Sulfate+Fluorouracil (Low-risk Group (Regimen T))	(yhvgskjoyi) = ntyxwgurup vpptsjaryh (cksrjmtqfq, ynywnccrly - miwlkohfrs) View more
ESC2021	Not Applicable	acute leukemia	2,375	Dexrazoxane	xmptkpdvac(anuqficany): OR = 1.15 (95% CI, 0.57 - 2.31), P-Value = 0.7 View more	-	29 Jun 2021
				No drug or placebo
NCT01231906 (AEWS1031, CTgov)	Phase 3	Peripheral Primitive Neuroectodermal Tumors \| Ewing Sarcoma	642	Laboratory Biomarker Analysis+Dexrazoxane+doxorubicin hydrochloride+Etoposide+Cyclophosphamide+Ifosfamide+Vincristine Sulfate (Arm A (Combination Chemotherapy))	(yyfhsqppoy) = ifxepkzbhs cbneoubnfr (ieangpxrqc, rasaodrcda - sgbfwwlwej) View more	-	04 May 2021
				Laboratory Biomarker Analysis+Dexrazoxane+doxorubicin hydrochloride+Etoposide+Cyclophosphamide+Ifosfamide+Topotecan Hydrochloride+Vincristine Sulfate (Arm B (Combination Chemotherapy, Topotecan Hydrochloride))	(yyfhsqppoy) = yfgyeqwlpj cbneoubnfr (ieangpxrqc, mfajzyoaag - twbfqmiojj) View more
P9404 \| P9425 \| P9426 \| DFCI 95-01 \| P9754 (ASCO2020)	Not Applicable	Neoplasms	173	Dexrazoxane+Doxorubicin	(pkqmvmrbmt) = uqcafxkobv ebayqmjlqs (ramyuhkbdm, 6.0 - 18.0) View more	Positive	25 May 2020
				Doxorubicin	(pkqmvmrbmt) = vilyqvqlxa ebayqmjlqs (ramyuhkbdm, 6.0 - 28.2) View more
NCT00038142 (CTgov)	Phase 2	Ewing Sarcoma	46	Dexrazoxane+ImmTher+Cyclophosphamide+Doxorubicin+Vincristine (Arm A: VACdxr With ImmTher)	doevjsernd(fjchtwqkml) = yixlnjzyfb qnqpznrpju (npezoqbgaz, mflurmabym - mupmqaurlh) View more	-	29 Jan 2020
				Dexrazoxane+Cyclophosphamide+Doxorubicin+Vincristine (Arm B: VACdxr)	doevjsernd(fjchtwqkml) = ixztegliyf qnqpznrpju (npezoqbgaz, oaahvezgph - puiyhphhxv) View more
NCT00928200 (CTgov)	Phase 1	Food Hypersensitivity \| Recurrent Adult Acute Lymphoblastic Leukemia \| refractory acute lymphoid leukemia in relapse	1	Dexrazoxane+doxorubicin+Hydrocortisone+Erwinase+dexamethasone+Methotrexate+Vincristine+Cytarabine	wizeolgosv(mwmqhywidp) = juxkwshoqu rznxnfilla (aehjgknxdd, zsmvlhcdar - ojexwrzdsz) View more	-	19 Feb 2019
AAML1031 (ASCO2018)	Not Applicable	Acute Myeloid Leukemia	1,014	Dexrazoxane	kgkaufpuak(ygakvqmtvv) = ygrnlgidky vdputlvsbz (tbvzjhwkgt ) View more	Positive	01 Jun 2018
				No Dexrazoxane	kgkaufpuak(ygakvqmtvv) = esfyzbjidq vdputlvsbz (tbvzjhwkgt ) View more

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