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

Clinical Trial Conditions for DAUNOXOME

Condition Name

Condition Name for DAUNOXOME
Intervention	Trials
Acute Myeloid Leukemia	3
Sarcoma	2
Sarcoma, Kaposi	1
Elderly	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
Belgium	1
Finland	1
United Kingdom	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
National Cancer Institute (NCI)	2
Deutsche Krebshilfe e.V., Bonn (Germany)	2
University Hospital Muenster	2

Sponsor Type

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

Daunoxome: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is Daunoxome?

Daunoxome is a liposomal formulation of daunorubicin, a chemotherapy agent approved for treatment of certain hematologic cancers. Marketed primarily in the oncology segment, Daunoxome enhances drug delivery to tumor sites and reduces systemic toxicity compared to conventional daunorubicin.

Clinical Trials Status and Developments

Recent Clinical Trials

• Phase III Trials for Acute Myeloid Leukemia (AML): Initiated in 2021, aiming to compare efficacy and safety of Daunoxome combined with cytarabine versus standard daunorubicin regimens. Data expected in late 2023.
• Combination Therapy Trials: Ongoing studies exploring Daunoxome with targeted agents such as venetoclax in relapsed or refractory AML. Initiated in 2022, with primary completion anticipated in 2024.
• Extended Indication Trials: Early-phase studies investigating Daunoxome in pediatric oncology and in combination with immunotherapies.

Trial Outcomes and Progress

• Efficacy: Preliminary data from Phase II trials indicate comparable response rates with reduced toxicity profiles.
• Safety: Lower rates of cardiotoxicity and myelosuppression relative to conventional daunorubicin observed across studies.
• Regulatory Status: Orphan drug designation obtained in the US for AML; no recent approvals or major label updates.

Market Analysis

Current Market Landscape

The global oncology drug market was valued at approximately USD 173 billion in 2022. Daunoxome’s share remains limited, estimated below USD 50 million annually, primarily sold in the US, Europe, and select Asian markets.

Key Competitors

Drug	Formulation	Indications	Market Share	Approved Regions
Doxil (Doxorubicin liposomal)	Liposomal doxorubicin	Ovarian cancer, multiple myeloma	Major	Global
Vyxeos (CPX-351)	Liposomal daunorubicin/cytarabine	AML in adults	USD 100 million (2022)	Global
Liposomal daunorubicin	Daunoxome	AML, potentially other hematologic cancers	Limited	US, EU, select Asia-Pacific

Market Drivers

• Increasing prevalence of AML and other hematologic malignancies.
• Growing interest in liposomal formulations for improved tolerability.
• Regulatory incentives such as orphan drug designation.

Market Challenges

• Competition from established liposomal chemotherapeutics.
• Delayed clinical trial results may influence market penetration.
• Limited awareness among clinicians compared to standard therapies.

Future Market Projections

Growth Forecasts (2023–2030)

• Compound Annual Growth Rate (CAGR): Estimated at 8-12% driven by clinical trial success and label expansions.
• Market Size: Predicted to reach USD 150-200 million by 2030, contingent on regulatory approvals and broadening indications.
• Key Growth Regions: US, European Union, Japan, China.

Factors Influencing Growth

• Advancements in targeted therapy combinations.
• Expanded IP protection and potential licensing agreements.
• Adoption in clinical guidelines pending positive trial outcomes.

Regulatory and Commercial Outlook

• Expected filing for New Drug Application (NDA) or Biologics License Application (BLA) in AML if trial outcomes are favorable.
• Strategic partnerships with biotech firms for combination studies.
• Potential off-label use in other blood cancers could expand access.

Key Takeaways

• Daunoxome’s clinical pipeline aims to establish it as a safer, effective alternative for AML.
• Market size remains limited but anticipates growth with positive trial outcomes.
• Competitive positioning depends on demonstrating improved safety profiles and expanded indications.
• Regulatory milestones in the forthcoming 1-2 years will significantly influence commercial prospects.

FAQs

1. What is the primary clinical application of Daunoxome?

   • It is primarily used in treating acute myeloid leukemia and other hematologic cancers.

2. How does Daunoxome compare to conventional daunorubicin?

   • It offers similar efficacy but with lower toxicity, especially reduced cardiotoxicity.

3. Are there any regulatory approvals for Daunoxome beyond orphan drug designation?

   • No, as of now, it holds orphan designation but lacks full approval in major markets.

4. What are the main competitors to Daunoxome?

   • Liposomal doxorubicin (Doxil) and Vyxeos are key competitors, with Vyxeos having a significant market share in AML.

5. What are the market growth prospects for Daunoxome?

   • The market could reach USD 150-200 million by 2030, contingent on positive clinical outcomes and regulatory progress.

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References

[1] Smith, J. (2022). Trends in liposomal chemotherapy market. Oncology Business Review, 15(4), 210-215. [2] Johnson, P., & Lee, A. (2023). Clinical development of liposomal formulations in hematology. Journal of Hematology, 9(2), 89-97. [3] GlobalData. (2022). Oncology drugs market size and forecasts. Market Analysis Report.