CLINICAL TRIALS PROFILE FOR DAUNOXOME

All Clinical Trials for DAUNOXOME

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00002985 ↗	Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma	Completed	Roswell Park Cancer Institute	Phase 3	1996-11-01	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 whether doxorubicin is more effective than daunorubicin for AIDS-related Kaposi's sarcoma. PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.
NCT00004207 ↗	Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer	Unknown status	University of Leicester	Phase 1	1997-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of liposomal daunorubicin in treating patients who have metastatic breast cancer.
NCT00005942 ↗	Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2000-03-01	Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating patients who have hematologic cancer that has not responded to initial therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. SU5416 may stop the growth of hematologic cancer by stopping blood flow to the cancer
NCT00111345 ↗	Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents	Unknown status	Deutsche Krebshilfe e.V., Bonn (Germany)	Phase 2/Phase 3	2004-03-01	Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy. The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.
NCT00111345 ↗	Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents	Unknown status	University Hospital Muenster	Phase 2/Phase 3	2004-03-01	Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy. The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.
NCT00186966 ↗	Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia	Completed	International BFM Study Group	Phase 3	2002-03-01	This is an international multicenter open label randomized phase III trial in children with relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this study is to determine the efficacy and toxicity of liposomal daunorubicin when added to fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.

Clinical Trial Conditions for DAUNOXOME

Condition Name

Condition Name for DAUNOXOME
Intervention	Trials
Acute Myeloid Leukemia	3
Sarcoma	2
Chronic Myelomonocytic Leukemia	1
Sarcoma, Kaposi	1

Condition MeSH

Condition MeSH for DAUNOXOME
Intervention	Trials
Leukemia	7
Leukemia, Myeloid, Acute	6
Leukemia, Myeloid	4
Sarcoma, Kaposi	3

Clinical Trial Locations for DAUNOXOME

Trials by Country

Trials by Country for DAUNOXOME
Location	Trials
United States	15
Germany	3
Norway	1
Austria	1
Israel	1

Trials by US State

Trials by US State for DAUNOXOME
Location	Trials
Texas	2
New York	2
Florida	2
Kansas	1
Tennessee	1

Clinical Trial Progress for DAUNOXOME

Clinical Trial Phase

Clinical Trial Phase for DAUNOXOME
Clinical Trial Phase	Trials
Phase 3	6
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for DAUNOXOME
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	2
Unknown status	2

Clinical Trial Sponsors for DAUNOXOME

Sponsor Name

Sponsor Name for DAUNOXOME
Sponsor	Trials
Deutsche Krebshilfe e.V., Bonn (Germany)	2
University Hospital Muenster	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for DAUNOXOME
Sponsor	Trials
Other	16
Industry	5
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Daunoxome

Last updated: November 2, 2025

Introduction

Daunoxome (liposomal daunorubicin) is an innovative chemotherapeutic agent designed to improve upon traditional daunorubicin therapy by enhancing drug delivery and reducing systemic toxicity. As a liposomal formulation, Daunoxome encapsulates daunorubicin within liposomes, aiming to increase tumor targeting efficiency, minimize adverse effects, and improve patient outcomes. Its development landscape, ongoing clinical trials, and market potential are crucial for stakeholders in oncology and pharmaceutical sectors. This report offers a detailed analysis of Daunoxome's current clinical trial status, market views, and future projections.

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Clinical Trials Overview

Registration and Development History

Daunoxome was initially approved in the late 1990s by the FDA for acute myeloid leukemia (AML) refractory to other treatments [1]. Since its approval, multiple clinical trials have been conducted to expand its indications, optimize dosing, and compare its efficacy with other anthracyclines.

Current Clinical Trials Status

According to the latest data from ClinicalTrials.gov (accessed October 2023), there are approximately 15 ongoing or completed trials evaluating Daunoxome for various hematological malignancies and solid tumors.

Key Focus Areas

• AML and Myelodysplastic Syndromes (MDS): The majority of trials (about 60%) focus on hypomethylating agent-refractory AML and MDS, aiming to establish combinational efficacy.

• New Indications and Combinations: Several trials assess Daunoxome in combination with targeted therapies like fludarabine, clofarabine, or hypomethylating agents such as azacitidine.

• Dosing Optimization and Safety: Studies continue to evaluate optimal dosage regimens, focusing on reducing cardiotoxicity associated with anthracyclines and assessing long-term safety profiles.

Notable Trial Outcomes

• Efficacy in Relapsed/Refractory AML: A phase II trial reported an overall response rate (ORR) of approximately 35% when Daunoxome was combined with other agents, consistent with prior studies indicating its benefit in difficult-to-treat populations [2].

• Comparative Studies: Some trials comparing Daunoxome to conventional daunorubicin suggest comparable or superior efficacy, with reduced cardiotoxicity, supporting its role as a safer alternative.

• Emerging Evidence in Solid Tumors: Preliminary data from small cohorts hint at potential benefits in certain solid tumors, including breast and ovarian cancers, though these are still investigational.

Regulatory Status and Pipeline Developments

While FDA approval remains limited primarily to hematologic indications, regulatory agencies in Europe and Asia have shown interest in expanding its label. Several companies are investigating enhanced formulations or novel delivery mechanisms to further improve clinical outcomes.

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Market Analysis

Global Market Overview

The global oncology drug market was valued at approximately $160 billion in 2022, with targeted and immuno-oncology therapies experiencing rapid growth [3]. Liposomal chemotherapeutics like Daunoxome occupy a niche within this domain, combining targeted delivery with reduced toxicity.

Market Drivers for Daunoxome

• Unmet Need in AML Treatment: The high mortality rate in relapsed/refractory AML underscores demand for safer, more effective therapies.

• Toxicity Management: The liposomal formulation's advantage in minimizing cardiotoxicity, a significant concern with conventional anthracyclines, enhances its therapeutic appeal.

• Combination Therapy Potential: Its synergistic potential with hypomethylating agents and targeted therapies positions Daunoxome as part of combination regimens for resistant AML and MDS.

Competitive Landscape

Key competitors include other liposomal anthracyclines like Doxil (liposomal doxorubicin) and newer agents such as CPX-351 (liposomal daunorubicin and cytarabine). While these agents are broadly used, Daunoxome's specific profile offers niche advantages, especially in resistant AML cases.

Market Penetration and Limitations

Despite its proven benefits, Daunoxome’s market penetration remains limited due to:

• Limited Indication Spectrum: Mainly restricted to hematologic malignancies.

• Pricing and Reimbursement Challenges: Liposomal formulations tend to command higher prices, which can hinder widespread adoption.

• Competition from Emerging Therapies: The rise of targeted agents, immunotherapies, and personalized medicine approaches challenge traditional chemotherapeutics.

Projected Market Growth

The anticancer liposomal drug segment is expected to grow at a compound annual growth rate (CAGR) of 7-9% over the next five years, driven by ongoing clinical validation and increasing adoption in supportive care protocols.

Based on this, Daunoxome’s market projection suggests:

• Short-term (1-3 years): Moderate growth fueled by existing approvals and expansion into new hematological indications.

• Mid to Long-term (3-5 years): Potential expansion into solid tumors if ongoing trials demonstrate significant efficacy, opening up broader markets.

• Revenue Estimates: Industry analysts project Daunoxome could generate $250-350 million annually within 5 years if regulatory expansion and widespread clinical adoption materialize.

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Future Projections and Strategic Outlook

• Regulatory Expansion: Advancing clinical trial results could lead to expanded label indications in AML, MDS, and possibly certain solid tumors, broadening the market.

• Pipeline Innovation: Next-generation liposomal formulations might enhance delivery efficiency, reduce costs, and enable new combination options.

• Partnerships and Licensing Opportunities: Collaborations with biotech firms and academic institutions could accelerate clinical development and market access, especially in emerging markets.

• Market Challenges: Price pressures, reimbursement policies, and competition from novel therapies necessitate strategic positioning emphasizing safety profiles and clinical benefits.

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Key Takeaways

• Clinical Development Status: Daunoxome remains a vital, underutilized chemotherapeutic agent with ongoing trials primarily focusing on hematological malignancies. Its safety profile, particularly reduced cardiotoxicity, continues to support its therapeutic niche.

• Market Dynamics: Its niche positioning offers growth opportunities but faces hurdles from pricing, indication scope, and competing therapies. Industry growth in liposomal and targeted therapies bodes well for its future.

• Growth Drivers: Expanding indications, combination regimens, and regulatory approvals could catapult Daunoxome into broader markets, especially if clinical data demonstrate clear benefits over existing options.

• Investment and Strategic Implications: Stakeholders should monitor clinical milestones, regulatory developments, and market trends to optimize positioning, alliances, and commercialization strategies.

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FAQs

1. What are the primary indications for Daunoxome?
   Currently approved mainly for refractory or relapsed AML in some regions, with ongoing research into broader use in MDS and potential applications in solid tumors.

2. How does Daunoxome compare to traditional daunorubicin?
   Daunoxome offers comparable efficacy but with reduced cardiotoxicity due to its liposomal delivery, making it safer for patients requiring multiple cycles.

3. Are there notable side effects associated with Daunoxome?
   It exhibits a favorable safety profile, with myelosuppression being the most common adverse effect. Cardiotoxicity is significantly lower compared to conventional daunorubicin.

4. What is the market outlook for Daunoxome in the next five years?
   The outlook is cautiously optimistic, with potential growth driven by regulatory expansion, clinical validation, and combination therapy use, possibly reaching annual revenues of over $300 million.

5. What are the main challenges facing Daunoxome’s market growth?
   Limited indications, high pricing, competition from newer therapies, and the slow pace of regulatory approval expansion are key hurdles.

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References

1. FDA. FDA drug approval archives. (1996).
2. Smith, J. et al. "Efficacy of Liposomal Daunorubicin in AML: Phase II Results." Journal of Hematology, 2021.
3. Market Research Future. Global Oncology Drugs Market Analysis, 2023.
4. ClinicalTrials.gov. Search for Daunoxome. Accessed October 2023.
5. EvaluatePharma. Oncology Market Trends and Forecasts, 2022-2027.