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Last Updated: April 17, 2025

CLINICAL TRIALS PROFILE FOR DAUNORUBICIN HYDROCHLORIDE


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505(b)(2) Clinical Trials for Daunorubicin Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT04992949 ↗ Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm Not yet recruiting Acute Leukemia French Association Phase 2 2021-10-01 The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research. The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival. CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy. Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT).
New Formulation NCT04992949 ↗ Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm Not yet recruiting French Intergroup of Myeloproliferative syndromes Phase 2 2021-10-01 The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research. The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival. CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy. Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT).
New Formulation NCT04992949 ↗ Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm Not yet recruiting French Innovative Leukemia Organisation Phase 2 2021-10-01 The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research. The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival. CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy. Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Daunorubicin Hydrochloride

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.
NCT00002471 ↗ Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma Completed Memorial Sloan Kettering Cancer Center Phase 2 1990-02-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.
NCT00002499 ↗ Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia Unknown status Grupo Argentino de Tratamiento de la Leucemia Aguda Phase 2/Phase 3 1990-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II/III trial to study the effectiveness of combination chemotherapy in treating children with relapsed acute lymphocytic leukemia.
NCT00002514 ↗ Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission Completed Medical Research Council Phase 3 1993-04-01 RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Daunorubicin Hydrochloride

Condition Name

Condition Name for Daunorubicin Hydrochloride
Intervention Trials
Acute Myeloid Leukemia 104
Leukemia 87
Acute Lymphoblastic Leukemia 31
Untreated Adult Acute Myeloid Leukemia 24
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Condition MeSH

Condition MeSH for Daunorubicin Hydrochloride
Intervention Trials
Leukemia 316
Leukemia, Myeloid, Acute 209
Leukemia, Myeloid 195
Precursor Cell Lymphoblastic Leukemia-Lymphoma 122
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Clinical Trial Locations for Daunorubicin Hydrochloride

Trials by Country

Trials by Country for Daunorubicin Hydrochloride
Location Trials
Canada 250
Japan 72
Spain 69
Germany 58
China 50
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Trials by US State

Trials by US State for Daunorubicin Hydrochloride
Location Trials
New York 101
California 100
Illinois 92
Ohio 91
Texas 91
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Clinical Trial Progress for Daunorubicin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Daunorubicin Hydrochloride
Clinical Trial Phase Trials
Phase 4 19
Phase 3 110
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Daunorubicin Hydrochloride
Clinical Trial Phase Trials
Completed 167
Recruiting 74
Active, not recruiting 42
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Clinical Trial Sponsors for Daunorubicin Hydrochloride

Sponsor Name

Sponsor Name for Daunorubicin Hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 125
Children's Oncology Group 34
Jazz Pharmaceuticals 19
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Sponsor Type

Sponsor Type for Daunorubicin Hydrochloride
Sponsor Trials
Other 406
Industry 135
NIH 128
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Daunorubicin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Daunorubicin Hydrochloride

Daunorubicin hydrochloride is a potent anthracycline antibiotic widely used in the treatment of various cancers, particularly hematological malignancies such as acute myeloid leukemia (AML). It works by inhibiting the synthesis of DNA and RNA, thereby preventing cancer cells from proliferating.

Clinical Trials Overview

Current Trials and Objectives

Several clinical trials are currently underway to evaluate the efficacy and safety of daunorubicin hydrochloride in combination with other therapies for treating AML and other cancers.

  • Combination Therapies: A phase II trial is studying the effectiveness of daunorubicin hydrochloride, cytarabine, and nilotinib in treating patients newly diagnosed with AML. This combination aims to enhance the killing of cancer cells by blocking enzymes necessary for cell growth[1].
  • Uproleselan Combination: A phase II/III trial is investigating the use of daunorubicin and cytarabine with or without uproleselan in older adult patients with AML. The primary objectives include comparing event-free survival (EFS) and overall survival (OS) between the two treatment arms[4].
  • Genomic Screening and Targeted Therapies: A multicenter Phase 1b/2 trial involves genomic screening to assign patients to specific sub-studies based on their AML subtype. This study aims to evaluate investigational therapies, including combinations that may include daunorubicin hydrochloride, to advance new targeted therapies for approval[1].

Safety and Efficacy

These trials focus on determining the safety, pharmacokinetics, and clinical activity of daunorubicin hydrochloride in various combinations. For instance, the trial evaluating daunorubicin, cytarabine, and uproleselan aims to describe the frequency and severity of adverse events and determine the rates of complete remission and other response criteria[4].

Emerging Trends

Recent trends in cancer treatment include the development of targeted therapies and novel drug combinations. Clinical trials are exploring new formulations and combinations to improve treatment outcomes, such as the use of daunorubicin hydrochloride with other agents like nilotinib or uproleselan[3].

Market Analysis

Market Size and Growth

The daunorubicin hydrochloride market has witnessed significant growth in recent years and is expected to continue this trend. As of 2023, the market was valued at approximately USD 1.2 billion and is projected to reach USD 2.4 billion by 2033, growing at a compound annual growth rate (CAGR) of around 7.2% from 2024 to 2033[5].

Drivers and Restraints

  • Increasing Cancer Prevalence: The rising incidence of cancers such as leukemia and breast cancer drives the demand for daunorubicin hydrochloride.
  • Advancements in Drug Delivery: Ongoing research aimed at expanding therapeutic applications and improving drug delivery systems contributes to market growth.
  • Regulatory Approvals: Stringent quality control measures and regulatory approvals significantly influence market dynamics.
  • Generic and Branded Formulations: The presence of both generic and branded formulations impacts pricing strategies and market competition[5].

Market Segmentation

The daunorubicin hydrochloride market is segmented by type, application, and region.

  • By Type: Branded and generic daunorubicin hydrochloride formulations.
  • By Application: Hematological cancers and solid tumors.
  • By Region: North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa[5].

Market Projections

Future Outlook

The daunorubicin hydrochloride market is poised for continued growth driven by several factors:

  • Advancements in Personalized Medicine: The integration of artificial intelligence and genomic profiling in treatment decision-making is expected to enhance the efficacy of daunorubicin hydrochloride.
  • Expanding Applications: Research into new formulations and combinations, particularly in solid tumors, will contribute to market expansion.
  • Emerging Economies: Rising adoption of chemotherapy treatments in emerging economies will further drive market growth[5].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as drug resistance, regulatory complexities, and healthcare disparities across regions. Addressing these challenges will require collaborative efforts from stakeholders.

"The integration of artificial intelligence and genomic profiling in treatment decision-making is expected to revolutionize cancer care, potentially increasing the efficacy of Daunorubicin Hydrochloride and other chemotherapy drugs."[5]

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the efficacy and safety of daunorubicin hydrochloride in combination with other therapies for AML and other cancers.
  • Market Growth: The daunorubicin hydrochloride market is expected to grow significantly, driven by increasing cancer prevalence, advancements in drug delivery, and regulatory approvals.
  • Segmentation: The market is segmented by type, application, and region, with both generic and branded formulations influencing market dynamics.
  • Future Outlook: The market is poised for growth driven by advancements in personalized medicine, expanding applications, and rising adoption in emerging economies.

FAQs

What is daunorubicin hydrochloride used for?

Daunorubicin hydrochloride is primarily used in the treatment of various cancers, particularly hematological malignancies such as acute myeloid leukemia (AML).

What are the current clinical trials involving daunorubicin hydrochloride?

Current trials include studies on combination therapies with cytarabine and nilotinib, and with uproleselan, as well as genomic screening to assign patients to specific sub-studies based on their AML subtype.

What is the projected market size for daunorubicin hydrochloride by 2033?

The daunorubicin hydrochloride market is projected to reach USD 2.4 billion by 2033, growing at a CAGR of around 7.2% from 2024 to 2033.

What are the key drivers of the daunorubicin hydrochloride market?

Key drivers include the increasing prevalence of cancers, advancements in drug delivery systems, and ongoing research aimed at expanding therapeutic applications.

What challenges does the daunorubicin hydrochloride market face?

The market faces challenges such as drug resistance, regulatory complexities, and healthcare disparities across regions.

Sources

  1. Mayo Clinic Research: Acute Myelogenous Leukemia Clinical Trials.
  2. Market Research Intellect: Global Daunorubicin Hydrochloride Market Size, Trends and Forecast.
  3. Market Research Intellect: Cytarabine And Daunorubicin Market Size And Projection.
  4. UCSD Clinical Trials: Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia.
  5. Data Horizon Research: Daunorubicin Hydrochloride Market Size, Growth and Analysis Report.

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