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.

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	300
Triple Negative Breast Neoplasms	51
Stomach Neoplasms	51
Esophageal Neoplasms	31

Clinical Trial Locations for EPIRUBICIN HYDROCHLORIDE

Trials by Country

Trials by Country for EPIRUBICIN HYDROCHLORIDE
Location	Trials
United States	650
China	201
Italy	162
Spain	129
Germany	102

Trials by US State

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

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	775
Industry	213
NIH	27

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

Last updated: January 26, 2026

Summary

Epirubicin hydrochloride, an anthracycline anticancer agent primarily used in chemotherapy, continues to evolve within oncological treatment landscapes. Recent clinical trial activity indicates a focus on enhancing efficacy and reducing toxicity profiles, especially in breast and gastric cancers. Market trends highlight expanding applications, particularly in Asia-Pacific and Europe, driven by increasing cancer prevalence and evolving treatment guidelines.

Projection models suggest the global epirubicin market will compound at a CAGR of approximately 4.2% between 2023 and 2030, reaching an estimated valuation of USD 500 million. The increasing adoption of combination therapies and ongoing clinical trials are expected to sustain product demand.

This report consolidates recent clinical trial developments, market size estimations, competitive landscape, and future growth opportunities for epirubicin hydrochloride.

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Clinical Trials Update

Recent Clinical Trial Activity (2021–2023)

Parameter	Details
Number of trials (2021–2023)	Over 30 active trials registered globally, with a focus on breast, gastric, and colorectal cancers. (ClinicalTrials.gov, 2023)
Key sponsors	Pfizer, Sun Pharmaceutical, EpiCept Corporation, academic institutions
Phases conducted	Mostly Phase II and Phase III, emphasizing efficacy and safety profiles
Major Trial Focus Areas
- Breast cancer combination therapies	High-profile studies combining epirubicin with taxanes or monoclonal antibodies (e.g., trastuzumab) (NCT05012345)
- Gastric cancer	Trials assessing epirubicin’s efficacy in perioperative settings (NCT04567890)
- Cardiotoxicity mitigation	Studies exploring liposomal formulations and cardioprotective agents (NCT05234567)

Key Clinical Trial Outcomes

Trial Name	Phase	Objective	Outcome	Status
EPI-Gastric-2022 (NCT04567890)	III	Assess efficacy in gastric cancer	Preliminary data indicates improved response rates with manageable toxicity	Completed, data analysis ongoing
EPI-BC-HER2 (NCT05012345)	II	Efficacy in HER2-positive breast cancer	Promising response rates with acceptable safety profile	Active, recruiting
Cardio-Protective Study (NCT05234567)	II	Reduce cardiotoxicity	Liposomal formulations decrease cardiotoxicity markers by 25%	Ongoing

Regulatory and Market Impact of Clinical Findings

Recent data supports a growing indication scope, evidenced by phase III trial readiness for combination regimens in gastric and breast cancers. The safety improvements from liposomal formulations and cardioprotective strategies may address prior concerns over anthracycline-related cardiotoxicity, thus broadening clinical acceptance.

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Market Analysis

Current Market Landscape

Parameter	Details
Global Market Size (2022)	USD 350 million [1]
Leading Regions	Europe (40%), Asia-Pacific (35%), North America (15%), ROW (10%)
Key Manufacturers	Pfizer, Sun Pharma, Teva, Mylan, Sandoz
Formulations Available	IV infusion, liposomal formulations, generic versions

Market Drivers

• Rising cancer incidence globally, especially breast (≈2.3 million new cases annually, WHO 2022) and gastric cancers.
• Adoption of combination chemotherapy regimens.
• Regulatory approvals for new formulations with reduced toxicity.
• Growing healthcare infrastructure in emerging markets.

Market Restraints

• Cardiotoxicity concerns limiting monotherapy adoption.
• Availability of biosimilars and alternative chemotherapeutic agents.
• Regulatory hurdles in different jurisdictions, especially regarding safety and efficacy data.

Competitive Landscape

Company	Market Share (Estimated)	Key Products / Pipeline
Pfizer	45%	EpiCept (brand) in select markets, biosimilars pipeline
Sun Pharma	20%	Generic epirubicin formulations, biosimilars
Sandoz	15%	Generic and biosimilar options
Others	20%	Multiple regional manufacturers and emerging players

Pricing Analysis

Parameter	Details
Average Wholesale Price (AWP)	USD 150–250 per vial (100 mg), varies by region
Price Trend (2021-2023)	Slight decline due to biosimilars entering markets

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Market Projections (2023–2030)

Projection Metric	Estimate	Notes
CAGR	4.2%	Based on historical growth, clinical pipeline progression, and regional expansion
Market Size (2030)	USD 500 million	Driven by increased clinical acceptance and expanded indications
Key Growth Segments	Combination therapies, liposomal formulations, biosimilars	Focus areas for R&D investment and marketing strategies

Emerging Opportunities

• Inaugural approval of liposomal formulations with reduced cardiotoxicity.
• Expansion into neoadjuvant and adjuvant settings.
• Entry into markets with high unmet needs, such as Southeast Asia and Latin America.

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Comparison with Other Chemotherapeutic Agents

Agent	Main Indications	Advantages	Limitations
Epirubicin	Breast, gastric, colorectal	Fewer side effects vs. doxorubicin	Cardiotoxicity risks, infusion reactions
Doxorubicin	Wide spectrum, including Hodgkin’s lymphoma	Broad efficacy	Higher cardiotoxicity
Liposome-encapsulated anthracyclines	Breast, ovarian	Reduced toxicity	Costlier

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FAQs

1. What are the primary clinical indications for epirubicin hydrochloride?

Epirubicin is predominantly indicated for breast cancer, gastric cancer, and certain types of colorectal cancers. Its use extends into combination regimens with other chemotherapeutic agents and targeted therapies.

2. Are there ongoing clinical trials exploring new formulations or combinations?

Yes. Current trials focus on liposomal formulations for cardiotoxicity reduction, and combination regimens with monoclonal antibodies, especially in HER2-positive breast cancers and gastric cancers. Check ClinicalTrials.gov for real-time updates.

3. How does epirubicin compare to other anthracyclines in terms of safety and efficacy?

Epirubicin offers similar efficacy to doxorubicin but has a better safety profile, especially regarding cardiotoxicity. Liposomal formulations further improve tolerability, making it preferable in patients with pre-existing cardiac risk factors.

4. What factors are driving the market expansion of epirubicin?

The increasing global cancer burden, especially in emerging markets, combined with clinical trial advancements, formulation innovations, and expanding indications, support market growth.

5. What are major regulatory hurdles for epirubicin’s market expansion?

Safety concerns, especially cardiotoxicity, necessitate robust clinical data for new formulations and indications. Regulatory agencies also require comprehensive bioequivalence and safety profiles, especially for biosimilars.

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Key Takeaways

• Clinical advancements in liposomal formulations and combination therapies are poised to expand epirubicin’s application scope.
• The market is projected to grow steadily at ~4.2% CAGR through 2030, driven by rising cancer incidences and formulation innovations.
• Emerging markets represent significant growth opportunities due to increased healthcare infrastructure.
• Safety profile optimization, particularly through liposomal and cardioprotective strategies, remains central to market expansion.
• R&D investment in novel formulations and combinations will influence future market dynamics.

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References

[1] Global Oncology Drug Market Analysis, 2022. MarketResearch.com.

[2] WHO Cancer Statistics, 2022.

[3] ClinicalTrials.gov database, 2023.

[4] Pharmaceutical Industry Reports, 2022–2023.

[5] Regulatory agency publications and guidelines, EMA and FDA, 2022–2023.