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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR IDAMYCIN PFS


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All Clinical Trials for Idamycin Pfs

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002812 ↗ Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia Completed National Cancer Institute (NCI) Phase 3 1996-09-01 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 and giving the drugs in different combinations may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
NCT00002812 ↗ Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia Completed Children's Oncology Group Phase 3 1996-09-01 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 and giving the drugs in different combinations may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
NCT00002816 ↗ Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia Completed National Cancer Institute (NCI) Phase 3 1996-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia.
NCT00002816 ↗ Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia Completed Children's Oncology Group Phase 3 1996-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia.
NCT00002833 ↗ Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 2 1994-10-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 cancer cells. Colony stimulating factors such as filgrastim 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 II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Idamycin Pfs

Condition Name

Condition Name for Idamycin Pfs
Intervention Trials
Leukemia 14
Acute Myeloid Leukemia 8
Untreated Adult Acute Myeloid Leukemia 5
Acute Myelogenous Leukemia 3
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Condition MeSH

Condition MeSH for Idamycin Pfs
Intervention Trials
Leukemia 30
Leukemia, Myeloid 22
Leukemia, Myeloid, Acute 21
Myelodysplastic Syndromes 10
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Clinical Trial Locations for Idamycin Pfs

Trials by Country

Trials by Country for Idamycin Pfs
Location Trials
United States 178
Canada 15
Australia 7
China 3
Netherlands 2
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Trials by US State

Trials by US State for Idamycin Pfs
Location Trials
Texas 19
California 10
Missouri 7
Illinois 6
Washington 6
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Clinical Trial Progress for Idamycin Pfs

Clinical Trial Phase

Clinical Trial Phase for Idamycin Pfs
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 1
Phase 2 15
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Clinical Trial Status

Clinical Trial Status for Idamycin Pfs
Clinical Trial Phase Trials
Completed 20
Recruiting 4
Withdrawn 3
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Clinical Trial Sponsors for Idamycin Pfs

Sponsor Name

Sponsor Name for Idamycin Pfs
Sponsor Trials
National Cancer Institute (NCI) 16
M.D. Anderson Cancer Center 14
Children's Oncology Group 4
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Sponsor Type

Sponsor Type for Idamycin Pfs
Sponsor Trials
Other 35
NIH 16
Industry 11
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Idamycin PFS: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Idamycin PFS, also known as idarubicin hydrochloride, is a semi-synthetic anthracycline antineoplastic agent used in the treatment of various types of leukemia. This article provides an update on recent clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Acute Promyelocytic Leukemia (APL)

A significant clinical trial conducted by the Children’s Oncology Group and funded by the National Cancer Institute has shown promising results for children with acute promyelocytic leukemia (APL). The trial combined all-trans retinoic acid and arsenic trioxide, with high-risk patients also receiving four doses of idarubicin. This regimen resulted in a 99% two-year overall survival rate for standard-risk APL and a 100% rate for high-risk APL. The event-free survival rates were 98% and 96%, respectively. This study highlights the efficacy of idarubicin in reducing the need for conventional chemotherapy in APL treatment[1].

Other Leukemias

Idarubicin hydrochloride is also indicated for acute non-lymphocytic leukemia (ANLL) and acute lymphocytic leukemia (ALL) as part of combination chemotherapy regimens. Clinical trials have demonstrated its effectiveness in achieving complete remission and improving overall survival rates when combined with other agents like cytarabine[4][5].

Market Analysis

Market Size and Growth

The global market for idarubicin hydrochloride is experiencing steady growth. As of 2023, the market size was valued at approximately USD 400 million and is projected to reach USD 650 million by 2032. This significant growth is driven by several key factors:

Increasing Demand for Effective Cancer Treatments

The rising incidence of cancer, particularly acute myeloid leukemia, is a major driver of the idarubicin hydrochloride market. The need for effective and targeted therapies has led to increased demand for this drug[2].

Clinical Efficacy

Idarubicin hydrochloride has demonstrated superior efficacy compared to other anthracyclines like daunorubicin in several clinical studies. For instance, studies have shown that idarubicin, when combined with cytarabine, results in higher complete remission rates and longer overall survival in patients with AML[2].

Expanding Healthcare Expenditure

Global healthcare expenditure is on the rise, driven by factors such as aging populations, increasing prevalence of chronic diseases, and government support for healthcare advancements. This trend is expected to boost the demand for advanced cancer treatments, including idarubicin hydrochloride[2].

Competitive Landscape

The market for idarubicin hydrochloride is competitive, with several pharmaceutical companies involved in its production and distribution. Ongoing research and development aim to improve the drug's efficacy and reduce its side effects, contributing to the competitive landscape[2].

Regulatory Environment

Strict regulations regarding drug safety and efficacy ensure that only high-quality products are available in the market. Compliance with these regulations is essential for pharmaceutical companies to maintain their market share[2].

Pharmacokinetics and Metabolism

Understanding the pharmacokinetics and metabolism of idarubicin hydrochloride is crucial for its effective use. The drug has a slow elimination rate from plasma, with a mean terminal half-life of around 22 hours. Its primary active metabolite, idarubicinol, has an even slower elimination rate, contributing to its prolonged therapeutic effects[2].

Regional Market Analysis

North America

North America is a significant market for idarubicin hydrochloride, driven by high healthcare spending and a strong demand for advanced cancer treatments. The region's aging population and the need for precise and convenient medication delivery systems further contribute to the market's growth[2].

Europe and Asia-Pacific

Europe and the Asia-Pacific region are also key markets, with growing healthcare expenditures and an increasing demand for effective cancer therapies. Government support and advancements in healthcare infrastructure in these regions are driving the market forward[2].

Challenges and Opportunities

Challenges

Hepatic and Renal Impairment

Idarubicin hydrochloride's pharmacokinetics can be affected by hepatic and renal impairment, necessitating dose adjustments and careful patient monitoring[2].

Cardiotoxicity

Idarubicin hydrochloride can cause myocardial toxicity, a significant side effect that needs to be managed through appropriate therapeutic measures[2].

Opportunities

Emerging Markets

The growing pharmaceutical sectors in emerging economies present opportunities for market expansion. Trends towards personalized treatment and effective inventory management in hospitals and clinics are boosting demand for precise dosing solutions like idarubicin hydrochloride[2].

Financial Trajectory

Revenue Projections

The projected growth of the idarubicin hydrochloride market from USD 400 million in 2023 to USD 650 million by 2032 indicates a robust financial trajectory. This growth is driven by increasing demand, clinical efficacy, and expanding healthcare expenditure[2].

Cost Considerations

While idarubicin hydrochloride is effective, its high cost can be a barrier to access, especially in regions with limited healthcare resources. Pharmaceutical companies are working to balance the cost with the therapeutic benefits to ensure wider accessibility[2].

Key Takeaways

  • Market Growth: The idarubicin hydrochloride market is projected to grow significantly from USD 400 million in 2023 to USD 650 million by 2032.
  • Clinical Efficacy: Idarubicin hydrochloride has demonstrated superior efficacy in treating various types of leukemia.
  • Pharmacokinetics: Understanding the drug's pharmacokinetics and metabolism is vital for its effective use.
  • Regional Markets: North America, Europe, and the Asia-Pacific region are significant contributors to the market's growth.
  • Challenges: Hepatic and renal impairment and cardiotoxicity are key challenges that need to be addressed.

FAQs

What is Idamycin PFS used for?

Idamycin PFS (idarubicin hydrochloride) is used in the treatment of acute non-lymphocytic leukemia (ANLL) and acute lymphocytic leukemia (ALL) as part of combination chemotherapy regimens[4].

What are the key drivers of the idarubicin hydrochloride market?

The key drivers include increasing demand for effective cancer treatments, clinical efficacy, and expanding healthcare expenditure[2].

What are the common side effects of idarubicin hydrochloride?

Common side effects include cardiotoxicity, hepatic and renal impairment, and other adverse reactions such as increased blood sugar, liver irritation, and bleeding[1][4].

How is idarubicin hydrochloride administered?

Idarubicin hydrochloride is administered intravenously over 5 to 10 minutes, preferably into a large vein, and should not be mixed with other drugs unless specific compatibility data are available[4].

What is the projected market size of idarubicin hydrochloride by 2032?

The market is projected to reach approximately USD 650 million by 2032[2].

Sources

  1. National Cancer Institute: "New drug combination helps children with acute promyelocytic leukemia avoid conventional chemotherapy"[1].
  2. Drug Patent Watch: "Generic IDARUBICIN HYDROCHLORIDE INN entry, drug patent"[2].
  3. BMJ Journals: "Efficacy, safety, and biomarker analysis of a phase II, single-arm trial"[3].
  4. Health Canada: "IDAMYCIN PFS (idarubicin hydrochloride injection)"[4].
  5. DailyMed: "IDAMYCIN PFS- idarubicin hydrochloride solution"[5].

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