CLINICAL TRIALS PROFILE FOR EPIRUBICIN HYDROCHLORIDE

All Clinical Trials for EPIRUBICIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002529 ↗	Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer	Completed	International Breast Cancer Study Group	Phase 3	1993-05-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during or after combination chemotherapy or hormone therapy alone in treating perimenopausal or postmenopausal women who have stage II or stage IIIA breast cancer.
NCT00002542 ↗	Tamoxifen in Treating Women With High-Risk Breast Cancer	Completed	NCIC Clinical Trials Group	Phase 3	1993-07-20	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to study the effectiveness of tamoxifen following surgery and chemotherapy in treating women who have stage I breast cancer at high risk of recurrence or stage II or stage III breast cancer.
NCT00002544 ↗	Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer	Completed	Arbeitsgemeinschaft fur Internistische Onkologie	Phase 3	1993-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if mitoxantrone is more effective with or without docetaxel. PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.
NCT00002615 ↗	Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer	Completed	Medical Research Council	Phase 3	1994-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not known whether receiving chemotherapy before surgery may be more effective than surgery alone in treating patients with stomach cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer.
NCT00002784 ↗	High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Combination Chemotherapy in Treating Women With High-Risk Breast Cancer	Completed	International Breast Cancer Study Group	Phase 3	1996-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if high-dose combination chemotherapy plus peripheral stem cell transplantation is more effective than standard combination chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to compare high-dose combination chemotherapy plus peripheral stem cell transplantation with standard combination chemotherapy in treating women with stage II or stage III breast cancer.
NCT00002866 ↗	Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer	Completed	NCIC Clinical Trials Group	Phase 1	1996-08-12	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person 's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and epirubicin with and without G-CSF in treating women with metastatic breast cancer.
NCT00002870 ↗	High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Locally Recurrent or Metastatic Breast Cancer	Completed	UNICANCER	Phase 3	1994-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. It is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more effective than standard therapy for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women who have locally recurrent or metastatic breast cancer.

Clinical Trial Conditions for EPIRUBICIN HYDROCHLORIDE

Condition Name

Condition Name for EPIRUBICIN HYDROCHLORIDE
Intervention	Trials
Breast Cancer	192
Gastric Cancer	35
Breast Neoplasms	22
Triple Negative Breast Cancer	18

Condition MeSH

Condition MeSH for EPIRUBICIN HYDROCHLORIDE
Intervention	Trials
Breast Neoplasms	299
Stomach Neoplasms	51
Triple Negative Breast Neoplasms	49
Esophageal Neoplasms	31

Clinical Trial Locations for EPIRUBICIN HYDROCHLORIDE

Trials by Country

Trials by Country for EPIRUBICIN HYDROCHLORIDE
Location	Trials
United States	650
China	199
Italy	162
Spain	129
Germany	102

Trials by US State

Trials by US State for EPIRUBICIN HYDROCHLORIDE
Location	Trials
Texas	31
California	26
New York	26
Florida	25
Pennsylvania	22

Clinical Trial Progress for EPIRUBICIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for EPIRUBICIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	18

Clinical Trial Status

Clinical Trial Status for EPIRUBICIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	216
Unknown status	79
Recruiting	76

Clinical Trial Sponsors for EPIRUBICIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for EPIRUBICIN HYDROCHLORIDE
Sponsor	Trials
National Cancer Institute (NCI)	26
Fudan University	24
German Breast Group	16

Sponsor Type

Sponsor Type for EPIRUBICIN HYDROCHLORIDE
Sponsor	Trials
Other	772
Industry	213
NIH	27

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

Last updated: October 27, 2025

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Introduction

Epirubicin Hydrochloride, a critical chemotherapeutic agent within the anthracycline class, continues to hold a significant position in oncology treatment regimens, particularly for breast cancer, gastric cancer, and other solid tumors. As an anthracycline, epirubicin's mechanism involves DNA intercalation and inhibition of topoisomerase II, leading to apoptosis of rapidly proliferating cancer cells. This analysis synthesizes recent clinical trial developments, evaluates current market dynamics, and offers projections for the drug’s future commercial trajectory.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

The development landscape for epirubicin hydrochloride is predominantly centered around optimizing efficacy, reducing toxicity, and expanding its therapeutic indications via novel formulation strategies and combination therapies.

• Enhanced Delivery Systems: Recent trials focus on liposomal formulations of epirubicin to mitigate adverse effects like cardiotoxicity and myelosuppression. For instance, phase II studies conducted globally explore liposomal epirubicin's pharmacokinetics and safety profile in breast and gastric cancers [1].

• Combination Regimens: Multiple ongoing phases investigate epirubicin combined with targeted therapies, such as trastuzumab and pertuzumab, aiming to improve outcomes in HER2-positive breast cancer. Early results suggest favorable synergy with manageable toxicity profiles [2].

• New Oncology Indications: Trials are evaluating epirubicin-based protocols in less traditional indications, including osteosarcoma and upper gastrointestinal cancers, reflecting a broader oncological spectrum for the drug.

• Biomarker-Driven Studies: Given the emergence of personalized medicine, recent clinical trials incorporate biomarker stratification to predict response and tailor dosing, notably with the integration of genomic profiling tools [3].

Regulatory and Approval Status

Epirubicin continues to be approved in numerous regions, including Europe, Australia, and certain Asian countries, for various cancers. Regulatory agencies are increasingly emphasizing clinical evidence demonstrating reduced toxicity, leading to expedited reviews of novel formulations and combination therapies.

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Market Analysis

Market Overview

The global epirubicin market is driven primarily by its application in breast cancer, gastric cancer, and other solid tumors. Oncology remains a high-growth sector, with the chemotherapeutic segment witnessing rising adoption of liposomal formulations and combination therapies, emphasizing improved safety profiles.

• Market Size and Revenue: Valued at approximately USD 200 million in 2022, the epirubicin market is projected to reach USD 300 million by 2028, growing at a CAGR of around 6–8% [4].

• Geographical Distribution: Major markets include Europe, Asia-Pacific, and North America, with Asia-Pacific registering rapid growth due to increased cancer prevalence and expanding healthcare infrastructure.

• Competitive Landscape: Epirubicin’s main competitors include doxorubicin and daunorubicin, with liposomal variants gaining significant strategic interest. Key players in this space include Pfizer, Teva, and Teva’s generics affiliates, as well as regional manufacturers.

Drivers and Challenges

• Drivers:

  • Rising prevalence of breast and gastric cancers.
  • Favorable efficacy and toxicity profiles of newer formulations.
  • Increasing clinical trials supporting expanded indications.

• Challenges:

  • Toxicity concerns, particularly cardiotoxicity, remain a barrier, especially in cumulative dosing.
  • Patent expirations and generic competition threaten pricing power.
  • Regulatory hurdles for novel formulations or combination regimens.

Market Segments and Trends

• Formulation Type:

  • Conventional Epirubicin remains dominant; however, liposomal versions are gaining traction.
  • Bioconjugates and targeted therapies are in early development stages.

• Application Area:

  • Breast cancer accounts for over 60% of sales, followed by gastric and esophageal cancers.
  • Growing research into epirubicin’s role as neoadjuvant therapy.

• Distribution Channels:

  • Hospital pharmacies dominate due to intravenous administration.
  • Increasing adoption of outpatient infusion services.

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Market Projection and Future Outlook

Growth Drivers & Opportunities

• Expanded Indications: Clinical trials indicating potential efficacy in less explored cancers could amplify revenue streams.
• Formulation Innovations: Liposomal and antibody-drug conjugates (ADCs) are poised to capture increased market share owing to retention of efficacy while reducing side effects.
• Personalized Medicine: Diagnostic advancements enabling patient stratification will improve therapeutic outcomes, making epirubicin-based therapies more precise and potentially more profitable.

Potential Barriers

• Toxicity Management: Cardioprotection strategies and monitoring protocols must evolve consonant with improved formulations.
• Pricing Pressures: Rising biosimilar entrants could compress profit margins.
• Regulatory Environment: Stringent approval pathways may limit rapid adoption of novel formulations.

Forecast Summary

By 2028, the global epirubicin market is expected to expand at a CAGR of approximately 6–8%. The growth trajectory reflects ongoing clinical validations, formulation innovations, and broader oncological applications. The increased focus on reducing adverse effects aligns with the development of liposomal variants, which are projected to account for an increasing proportion of the market share.

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Conclusion

Epirubicin hydrochloride remains a vital chemotherapeutic agent with a dynamic landscape shaped by clinical innovations and shifting market demands. Advances in drug delivery systems and combination therapies promise to sustain its relevance. However, the prospect heavily depends on balancing efficacy improvements with toxicity mitigation, navigating regulatory pathways, and responding to competitive pressures.

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Key Takeaways

• Clinical innovations, especially liposomal formulations and combination regimens, are central to the future development of epirubicin.
• The market is projected to grow consistently over the next five years, driven by expanding indications and technological advancements.
• Safety profiles, notably cardiotoxicity, remain critical considerations influencing regulatory and clinical adoption.
• Geographic expansion in Asia-Pacific and emerging markets offers significant growth opportunities.
• Competitive pressure from biosimilars and generics necessitates continuous innovation and strategic positioning.

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FAQs

1. What are the primary clinical advantages of liposomal epirubicin over traditional formulations?
   Liposomal epirubicin offers improved pharmacokinetics, reduced cardiotoxicity, and enhanced tumor targeting, leading to better tolerability and efficacy in certain patient populations [1].

2. Are there notable ongoing trials exploring new indications for epirubicin?
   Yes, current trials investigate its potential in osteosarcoma, gastric, and esophageal cancers, as well as in combination with targeted biologic agents, aiming to widen its therapeutic scope [2].

3. How does epirubicin compare to other anthracyclines like doxorubicin regarding safety?
   Epirubicin generally exhibits a lower risk of cardiotoxicity compared to doxorubicin, especially at equivalent doses, making it a preferred choice in patients with pre-existing cardiac risks [3].

4. What is the impact of biosimilars on the epirubicin market?
   Biosimilar versions threaten the pricing power of established brand-name epirubicin products, potentially leading to reduced margins but also increasing overall market accessibility.

5. What future developments could influence epirubicin's market trajectory?
   Innovations in targeted delivery, biomarker-guided therapy, and the success of combined treatment protocols will significantly shape its future positioning.

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Sources

[1] Recent advances in liposomal anthracyclines, Journal of Oncology Pharmacy Practice, 2022.
[2] Clinical trials of epirubicin in HER2-positive breast cancer, ClinicalTrials.gov.
[3] Comparison of cardiotoxicity between epirubicin and doxorubicin, Cardio-Oncology, 2021.
[4] Market Research Future, Epirubicin Market Analysis, 2022.