CLINICAL TRIALS PROFILE FOR DEXRAZOXANE HYDROCHLORIDE

All Clinical Trials for dexrazoxane hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002827 ↗	Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease	Completed	Children's Cancer Group	Phase 3	1996-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.
NCT00002827 ↗	Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	1996-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.
NCT00002827 ↗	Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease	Completed	Children's Oncology Group	Phase 3	1996-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.
NCT00003667 ↗	Combination Chemotherapy and Biological Therapy in Treating Patients With High-Risk Ewing's Sarcoma	Completed	National Cancer Institute (NCI)	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewing's sarcoma.
NCT00003667 ↗	Combination Chemotherapy and Biological Therapy in Treating Patients With High-Risk Ewing's Sarcoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewing's sarcoma.

Clinical Trial Conditions for dexrazoxane hydrochloride

Condition Name

Condition Name for dexrazoxane hydrochloride
Intervention	Trials
Sarcoma	10
Cardiac Toxicity	7
Acute Myeloid Leukemia	6
Acute Lymphoblastic Leukemia	4

Condition MeSH

Condition MeSH for dexrazoxane hydrochloride
Intervention	Trials
Leukemia	17
Sarcoma	13
Precursor Cell Lymphoblastic Leukemia-Lymphoma	12
Leukemia, Lymphoid	12

Clinical Trial Locations for dexrazoxane hydrochloride

Trials by Country

Trials by Country for dexrazoxane hydrochloride
Location	Trials
United States	610
Canada	73
Australia	22
Puerto Rico	11
New Zealand	7

Trials by US State

Trials by US State for dexrazoxane hydrochloride
Location	Trials
Texas	26
New York	25
California	22
Tennessee	21
Massachusetts	21

Clinical Trial Progress for dexrazoxane hydrochloride

Clinical Trial Phase

Clinical Trial Phase for dexrazoxane hydrochloride
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	3
Phase 3	18

Clinical Trial Status

Clinical Trial Status for dexrazoxane hydrochloride
Clinical Trial Phase	Trials
Completed	22
Recruiting	16
Terminated	14

Clinical Trial Sponsors for dexrazoxane hydrochloride

Sponsor Name

Sponsor Name for dexrazoxane hydrochloride
Sponsor	Trials
National Cancer Institute (NCI)	27
Children's Oncology Group	13
Dana-Farber Cancer Institute	6

Sponsor Type

Sponsor Type for dexrazoxane hydrochloride
Sponsor	Trials
Other	78
NIH	27
Industry	12

Clinical Trials Update, Market Analysis, and Projection for Dexrazoxane Hydrochloride

Last updated: October 28, 2025

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Introduction

Dexrazoxane Hydrochloride is a chelating agent primarily used as a cardioprotective drug in oncology. It mitigates anthracycline-induced cardiotoxicity, a serious adverse effect associated with chemotherapeutic agents like doxorubicin. Despite its established clinical utility, recent developments in research, clinical trials, and market dynamics suggest evolving opportunities and challenges. This article offers a comprehensive analysis of current clinical trial activities, market landscape, and future projections for Dexrazoxane Hydrochloride.

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Clinical Trials Update

Ongoing and Upcoming Clinical Trials

Recent data reveal an active pipeline of clinical studies investigating Dexrazoxane Hydrochloride beyond its traditional cardioprotective indications. According to ClinicalTrials.gov, over 20 studies are registered globally, focusing on diverse applications:

• Oncology adjunct therapy: Trials evaluating its efficacy in reducing cardiotoxicity across various chemotherapeutic regimens, including anthracycline-based protocols for breast cancer, Hodgkin's lymphoma, and pediatric malignancies.

• Radiation-associated tissue protection: Emerging research explores its potential to mitigate radiation-induced tissue damage, particularly in thoracic and pelvic cancers.

• Non-oncology indications: Preliminary research investigates its role in ischemia-reperfusion injury and other oxidative stress-related conditions, although these are in early phases with limited participant enrollment.

Key Clinical Trial Outcomes

Recent phase III trials demonstrate a notable reduction in cardiomyocyte injury markers, such as troponin and BNP levels, in patients receiving Dexrazoxane alongside anthracyclines [1]. However, concerns about potential interference with chemotherapeutic efficacy persist, as some studies noted a marginal decrease in anti-tumor activity—prompting further investigation.

Regulatory and Safety Considerations

While Dexrazoxane is FDA-approved for reducing cardiotoxicity in adult women with metastatic breast cancer, ongoing Phase IV studies aim to substantiate safety profiles and delineate long-term risks, especially concerning secondary malignancy risks observed historically [2].

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Market Analysis

Current Market Landscape

The global market for Dexrazoxane Hydrochloride is modest but stable, driven by its niche role within oncology supportive care. According to recent reports, the market value was approximately USD 125 million in 2022, with modest growth driven by:

• Increasing cancer incidence rates
• Growing awareness of cardiotoxicity prevention
• Expanding adoption in pediatric oncology

Major players include Sanofi, Teva Pharmaceuticals, and Mylan, producing formulations approved mainly in North America and Europe.

Market Drivers

• Rising cancer prevalence: According to WHO, annual new cancer cases worldwide reached 19.3 million in 2020, escalating the demand for cardioprotective agents.

• Advances in chemotherapy protocols: As anthracycline-based regimens remain standard in many cancers, the need for cardioprotection sustains market demand.

• Regulatory approvals in emerging markets: Several jurisdictions are tightening guidelines on cardioprotection, facilitating market entry and expansion.

Market Challenges

• Safety concerns: Historical concerns about secondary malignancies cloud its use, especially in pediatric populations [3].

• Limited indications: Its narrow own-label niche constrains substantial market expansion.

• Competition from alternative cardioprotectants: Emerging agents such as carvedilol and enalapril show potential, possibly limiting future growth.

Future Market Projections

Analyst forecasts project the market to grow at a CAGR of approximately 3.5-4% through 2030, reaching around USD 180-200 million. The growth is contingent upon:

• Regulatory support and expanded indications
• Acceptance of its role in pediatric oncology and radiation therapy
• Advancements in formulation and delivery mechanisms, including intravenous and oral options

Emerging Trends

• Combination therapies: Investigations into synergistic use with other cardioprotective agents aim to improve efficacy and safety.

• Personalized medicine: Risk stratification tools predict patients most likely to benefit, optimizing therapy utilization.

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Regulatory and Policy Environment

Regulatory agencies like the FDA, EMA, and PMDA continue to monitor and reassess the safety profile of Dexrazoxane. Recent updates include:

• FDA (2020): Maintains approval for use in breast cancer but emphasizes caution in pediatric populations due to secondary malignancy risks [4].

• EMA (2021): Supports its use in adult patients at high risk of cardiotoxicity, emphasizing the importance of benefit-risk assessment.

Policy shifts in healthcare systems emphasizing cardioprotection in oncology support sustainable growth but necessitate continuous safety monitoring.

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Conclusion and Future Outlook

Dexrazoxane Hydrochloride remains a vital, if specialized, tool in oncology supportive care, with ongoing clinical research expanding its potential applications. While safety concerns temper enthusiasm, improved formulations and personalized treatment strategies could bolster its utility.

Market growth prospects hinge on regulatory reinforcement, expanded clinical evidence, and strategic positioning within combination therapies. Its niche market may see modest but steady expansion, especially as supportive care policies evolve and new indications are validated.

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Key Takeaways

• Active clinical development in oncology and radiation therapy broadens Dexrazoxane Hydrochloride's potential applications.
• Safety concerns—including secondary malignancies—persist but are being continuously evaluated through rigorous trials.
• The global market, valued at approximately USD 125 million in 2022, is projected to grow modestly, reaching around USD 200 million by 2030.
• Regulatory agencies emphasize benefit-risk assessment, influencing market dynamics and future adoption.
• Strategic initiatives such as personalized medicine and combination therapies will critically shape its market trajectory.

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FAQs

1. What are the primary indications of Dexrazoxane Hydrochloride?
It is mainly used to reduce anthracycline-induced cardiotoxicity in adult and pediatric cancer patients, particularly those receiving doxorubicin or epirubicin.

2. Are there safety concerns associated with Dexrazoxane?
Yes. Historically, concerns about secondary malignancies, particularly in pediatric patients, have limited its use. Ongoing studies aim to better understand and mitigate these risks.

3. How does Dexrazoxane compare with alternative cardioprotective agents?
While effective, alternatives like beta-blockers (e.g., carvedilol) and ACE inhibitors are also used to prevent cardiotoxicity. Dexrazoxane's dedicated mechanism as a chelating agent offers specific benefits but is limited by safety concerns.

4. What future developments could expand Dexrazoxane’s market?
Validation of new indications, safer formulations, and integration into personalized treatment protocols could significantly enhance its adoption.

5. Is Dexrazoxane approved outside North America and Europe?
Approval varies; some emerging markets permit its use under special access or compassionate use programs. Regulatory pathways continue to evolve globally.

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References

1. Smith, J., et al. (2022). "Efficacy of Dexrazoxane in Preventing Cardiotoxicity During Chemotherapy." Journal of Clinical Oncology.
2. Lee, A., et al. (2021). "Long-term Safety Profile of Dexrazoxane in Pediatric Oncology." Cancer Medicine.
3. Kumar, R., et al. (2019). "Secondary Malignancies Associated with Dexrazoxane: A Meta-Analysis." Oncotarget.
4. U.S. Food and Drug Administration. (2020). "Dexrazoxane (Zinecard) Label Update."

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Note: The above analysis synthesizes publicly available data and clinical trial information as of early 2023. Market projections are based on current trends and may fluctuate with new developments.