CLINICAL TRIALS PROFILE FOR DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

All Clinical Trials for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001059 ↗	Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS	Completed	Amgen	Phase 2	1969-12-31	To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
NCT00001059 ↗	Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS	Completed	Sequus Pharmaceuticals	Phase 2	1969-12-31	To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
NCT00001059 ↗	Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
NCT00002093 ↗	A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.	Completed	Nexstar Pharmaceuticals	Phase 3	1969-12-31	To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.
NCT00002105 ↗	Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma	Completed	Sequus Pharmaceuticals	Phase 3	1969-12-31	To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
NCT00002147 ↗	Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.	Completed	Sequus Pharmaceuticals	Phase 3	1969-12-31	To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

Clinical Trial Conditions for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Condition Name

Condition Name for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Intervention	Trials
Ovarian Cancer	69
Breast Cancer	56
Fallopian Tube Cancer	30
Multiple Myeloma	24

Condition MeSH

Condition MeSH for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Intervention	Trials
Ovarian Neoplasms	130
Carcinoma, Ovarian Epithelial	100
Breast Neoplasms	82
Fallopian Tube Neoplasms	58

Clinical Trial Locations for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Trials by Country

Trials by Country for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Location	Trials
Italy	135
China	87
Spain	63
Germany	57
Canada	53

Trials by US State

Trials by US State for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Location	Trials
California	79
New York	68
Texas	58
Florida	51
Ohio	49

Clinical Trial Progress for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Clinical Trial Phase

Clinical Trial Phase for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	16
Phase 4	10

Clinical Trial Status

Clinical Trial Status for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Clinical Trial Phase	Trials
Completed	171
Recruiting	62
Terminated	52

Clinical Trial Sponsors for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Sponsor Name

Sponsor Name for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Sponsor	Trials
National Cancer Institute (NCI)	67
Merck Sharp & Dohme Corp.	12
M.D. Anderson Cancer Center	12

Sponsor Type

Sponsor Type for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Sponsor	Trials
Other	424
Industry	253
NIH	70

Doxorubicin Hydrochloride (Liposomal): Clinical Trials Update, Market Analysis, and Projection

Last updated: October 28, 2025

Introduction

Doxorubicin Hydrochloride (Liposomal), marketed primarily as Doxil® (or Caelyx® outside the U.S.), represents a significant advancement in anthracycline chemotherapy. Encapsulated within liposomes, this formulation improves drug delivery to tumors while reducing systemic toxicity, notably cardiotoxicity—a critical concern with conventional doxorubicin. As a cornerstone in oncology, particularly in breast cancer, ovarian cancer, and multiple myeloma, the drug continues to evolve through ongoing clinical trials, influencing market dynamics and projections. This comprehensive report analyzes recent clinical developments, evaluates market trends, and forecasts future growth for liposomal doxorubicin.

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Clinical Trials Update

Recent and Ongoing Trials

The clinical landscape for liposomal doxorubicin remains vibrant, with multiple trials focusing on expanding indications, optimizing dosing regimens, and combining with novel agents.

1. Expanded Indications in Oncology:
   Recent Phase II/III trials investigate liposomal doxorubicin in recurrent ovarian cancer, metastatic breast cancer, and soft tissue sarcomas. For example, a Phase II trial (NCT05070927) evaluated liposomal doxorubicin combined with pembrolizumab in advanced ovarian carcinoma. Preliminary results indicated manageable safety profiles and promising antitumor activity, prompting further Phase III studies.

2. Combination Therapies:
   The trend toward combining liposomal doxorubicin with targeted therapies, immune checkpoint inhibitors, and anti-angiogenic agents continues. A notable ongoing trial (NCT04367849) explores its use with bevacizumab in recurrent glioblastoma, reflecting interest in expanding to CNS malignancies.

3. Dose Optimization and Safety Profiles:
   New trials are assessing dosing schedules to maximize efficacy and mitigate adverse effects. For example, a multicenter phase II trial (NCT04593820) compares weekly versus every-three-week dosing in metastatic breast cancer, aiming to establish best practices for dosing.

4. Novel Delivery Platforms:
   Researchers are examining liposomal modifications and co-delivery systems. Nanoparticle formulations integrating doxorubicin with other chemotherapeutics or immunomodulators are under clinical evaluation, emphasizing innovation in drug delivery.

Regulatory and Approval Status

While liposomal doxorubicin has received approval in multiple jurisdictions, ongoing trials may support label expansions. Regulatory agencies like the FDA and EMA remain receptive to data on efficacy and safety, particularly in less explored tumor types. The continued clinical validation is foundational for potential new indications and improved delivery systems.

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Market Analysis

Market Size and Dynamics

The global liposomal doxorubicin market was valued at approximately USD 800 million in 2022 [1]. Its growth is driven by:

• Increased prevalence of cancers treatable with anthracyclines.
• The shift towards precision medicine encouraging targeted drug formulations.
• Growing awareness of reduced cardiotoxicity benefits.

Key Market Players

Bayer Pharmaceuticals' Doxil® remains the dominant product globally. Other players include Teva Pharmaceuticals and Sun Pharma, which market generic liposomal doxorubicin formulations. Patent expirations and biosimilar entries are expected to intensify price competition and broaden accessibility.

Regional Market Insights

• North America: Holds the largest share, driven by high cancer prevalence, advanced healthcare infrastructure, and strong regulatory support.
• Europe: Exhibits steady growth, bolstered by expanding oncology facilities and supportive reimbursement policies.
• Asia-Pacific: Projected to be the fastest-growing region, fueled by rising cancer incidence, increasing healthcare expenditure, and affordability improvements.

Market Challenges

• Patent expirations for leading formulations threaten revenue streams.
• High manufacturing costs of liposomal formulations limit extensive adoption in low-income markets.
• Competition from newer targeted therapies may cannibalize market share.

Future Market Drivers

• Development of next-generation liposomal carriers with enhanced targeting and reduced toxicity.
• The incorporation of liposomal doxorubicin into combination regimens with immunotherapies.
• Increasing clinical evidence supporting expanded indications.

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Market Projection

Forecasts suggest a compound annual growth rate (CAGR) of approximately 6% between 2023 and 2030, driven primarily by:

• Expanded clinical approvals: Anticipated label expansions could open markets for additional indications, including hematological malignancies and solid tumors.
• Technological advancements: Next-generation liposomal carriers with improved specificity and pharmacokinetics.
• Partnerships and collaborations: Pharma alliances facilitating accelerated development and commercialization.

By 2030, the market could surpass USD 1.5 billion, with emergent markets and innovative formulations contributing significantly to growth. The increasing integration with immunotherapy regimens is expected to further bolster demand.

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Regulatory and Commercial Outlook

Regulatory bodies are increasingly receptive to novel liposomal formulations, with accelerated pathways available for drugs addressing unmet medical needs. Companies investing in combinatorial clinical trials and novel delivery platforms are positioned to capitalize on expansion opportunities.

Commercial strategies should focus on:

• Expanding indications based on robust clinical data.
• Enhancing manufacturing efficiencies for cost reduction.
• Strengthening partnerships with healthcare providers for broader adoption.

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Conclusion

Liposomal doxorubicin remains a pivotal player in oncology, with ongoing clinical trials poised to enhance its therapeutic scope. Market growth is underpinned by clinical validation, technological innovation, and expansion into emerging markets. The next decade promises significant evolution, with improved formulations and combination strategies driving sustained demand and profitability.

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Key Takeaways

• Clinical Pipeline Bolsters Future Use: Current trials focus on expanding indications, optimizing dosing, and combining liposomal doxorubicin with immunotherapies and targeted agents, promising broader clinical applications.
• Market Growth Is Steady but Competitive: Valued at over USD 800 million in 2022, the market is expected to grow at approximately 6% CAGR, reaching USD 1.5 billion by 2030.
• Innovation Is Critical: Next-generation liposomal carriers and co-delivery systems are poised to redefine therapeutic efficacy and safety.
• Regulatory Support Is Evolving: Accelerated approval pathways and label expansions will likely facilitate market penetration for new indications.
• Regional Expansion Is Key: Asia-Pacific and other emerging regions will drive volume growth, supported by increasing healthcare infrastructure and cancer prevalence.

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FAQs

1. What are the primary benefits of liposomal doxorubicin compared to conventional doxorubicin?
   Liposomal encapsulation reduces cardiotoxicity, enhances tumor targeting, and allows higher dosing with manageable side effects, improving patient outcomes.

2. Are there new indications for liposomal doxorubicin under clinical evaluation?
   Yes, ongoing trials are exploring its use in recurrent ovarian cancer, metastatic breast cancer, soft tissue sarcomas, and potentially CNS malignancies.

3. How does the market for liposomal doxorubicin compare geographically?
   North America leads due to high cancer prevalence and advanced healthcare infrastructure; Asia-Pacific shows the highest growth potential owing to rising incidence and expanded healthcare access.

4. What challenges threaten the growth of liposomal doxorubicin?
   Patent expirations, high manufacturing costs, competition from newer therapies, and limited reimbursement in certain regions are notable hurdles.

5. What innovations could influence the future of liposomal doxorubicin?
   Development of targeted liposomal carriers, co-delivery systems, and combination therapies with immunomodulators are poised to enhance efficacy and expand use.

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References

[1] MarketWatch. “Liposomal Doxorubicin Market Size, Share, Growth, Trend, and Forecast to 2030.”
[2] ClinicalTrials.gov. “Current Studies on Liposomal Doxorubicin.”
[3] GlobalData. “Oncology Pipeline and Market Forecasts.”