CLINICAL TRIALS PROFILE FOR IDARUBICIN HYDROCHLORIDE PFS

All Clinical Trials for Idarubicin Hydrochloride Pfs

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002517 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1993-03-01	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. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.
NCT00002532 ↗	Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia	Unknown status	Hannover Medical School	Phase 2	1993-01-01	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 trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory acute lymphocytic leukemia.
NCT00002549 ↗	Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia	Unknown status	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1993-11-01	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 or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia.
NCT00002565 ↗	Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1994-05-25	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. It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkin's lymphoma.
NCT00002565 ↗	Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 3	1994-05-25	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. It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkin's lymphoma.
NCT00002609 ↗	Monoclonal Antibody Therapy and Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia in Remission	Completed	National Cancer Institute (NCI)	Phase 2	1994-08-01	RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them, without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus monoclonal antibody therapy in treating patients with acute promyelocytic leukemia in remission.
NCT00002609 ↗	Monoclonal Antibody Therapy and Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia in Remission	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	1994-08-01	RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them, without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus monoclonal antibody therapy in treating patients with acute promyelocytic leukemia in remission.

Clinical Trial Conditions for Idarubicin Hydrochloride Pfs

Condition Name

Condition Name for Idarubicin Hydrochloride Pfs
Intervention	Trials
Acute Myeloid Leukemia	92
Leukemia	61
Untreated Adult Acute Myeloid Leukemia	15
Myelodysplastic Syndromes	15

Condition MeSH

Condition MeSH for Idarubicin Hydrochloride Pfs
Intervention	Trials
Leukemia	218
Leukemia, Myeloid, Acute	193
Leukemia, Myeloid	176
Myelodysplastic Syndromes	50

Clinical Trial Locations for Idarubicin Hydrochloride Pfs

Trials by Country

Trials by Country for Idarubicin Hydrochloride Pfs
Location	Trials
United States	718
China	77
Spain	69
Japan	62
France	61

Trials by US State

Trials by US State for Idarubicin Hydrochloride Pfs
Location	Trials
Texas	62
California	46
New York	40
Illinois	31
Ohio	27

Clinical Trial Progress for Idarubicin Hydrochloride Pfs

Clinical Trial Phase

Clinical Trial Phase for Idarubicin Hydrochloride Pfs
Clinical Trial Phase	Trials
PHASE3	4
PHASE2	14
PHASE1	2

Clinical Trial Status

Clinical Trial Status for Idarubicin Hydrochloride Pfs
Clinical Trial Phase	Trials
Completed	127
RECRUITING	67
Unknown status	43

Clinical Trial Sponsors for Idarubicin Hydrochloride Pfs

Sponsor Name

Sponsor Name for Idarubicin Hydrochloride Pfs
Sponsor	Trials
National Cancer Institute (NCI)	51
M.D. Anderson Cancer Center	23
PETHEMA Foundation	15

Sponsor Type

Sponsor Type for Idarubicin Hydrochloride Pfs
Sponsor	Trials
Other	345
Industry	89
NIH	53

Clinical Trials Update, Market Analysis, and Projection for Idarubicin Hydrochloride Pfs

Last updated: October 28, 2025

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Introduction

Idarubicin Hydrochloride Pfs (perforation-free suspension) is an anthracycline chemotherapeutic agent primarily used in the treatment of acute myeloid leukemia (AML). Its efficacy in remission induction, combined with favorable pharmacokinetic profiles, has cemented its role in oncology. Recent developments, ongoing clinical trials, and potential market trajectories are shaping the future landscape for this drug.

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Clinical Trials Update

Current Clinical Trial Landscape

The clinical investigation of Idarubicin Hydrochloride remains active, with a specific focus on optimizing dosing regimens and expanding indications beyond AML. As of recent updates, multiple phase II and III trials are underway.

• Phase II Trials: These assess the efficacy of Idarubicin Hydrochloride in tandem with other agents in refractory or relapsed AML. A notable trial (NCT04831533) evaluates combination therapy with emerging targeted agents to address resistance issues.

• Phase III Trials: An ongoing study (NCT04615271) compares Idarubicin Hydrochloride versus Daunorubicin-based regimens, aiming to refine front-line AML protocols.

Regulatory and Safety Data

Recent safety data reaffirm Idarubicin's manageable toxicity profile when administered under controlled conditions. Cardiotoxicity, a prevalent concern with anthracyclines, remains under vigilant monitoring, with dose adjustments and cardioprotective agents incorporated into trial designs.

Innovations in Formulation

Innovative formulations, including nanoparticle-based delivery systems, are under preclinical and early-phase clinical assessment to minimize systemic toxicity while maximizing therapeutic potency. These advancements could address unmet needs related to cumulative cardiotoxicity.

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Market Analysis

Current Market Dynamics

The global oncology therapeutics market, particularly the AML segment, is experiencing substantial growth driven by increasing incidence rates, novel treatment regimens, and expanding understanding of disease biology.

• Market Size & Growth: The AML therapeutics market was valued at approximately USD 1.4 billion in 2022, with projections reaching USD 2.4 billion by 2030, growing at a CAGR of around 6.4%.[1]

• Key Players & Competition: Major competitors include cytarabine, daunorubicin, and newer targeted therapies such as FLT3 inhibitors and IDH inhibitors. Idarubicin's niche remains as a preferred agent in certain regimens.

• Pricing & Reimbursement: As a generic, Idarubicin Hydrochloride benefits from cost advantages that favor adoption in various healthcare settings, particularly in regions with constrained budgets.

Unmet Needs and Opportunities

Despite its proven efficacy, Idarubicin faces limitations due to cardiotoxic risks and resistance development. The ongoing development of combination therapies and advanced formulations offers avenues to extend its clinical utility. Additionally, expanding indications, such as use in other hematological malignancies, could further solidify its market presence.

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Market Projection

Future Growth Drivers

• Innovative Formulations: Nanoparticle delivery systems and targeted delivery methods could notably enhance therapeutic indices, increase safety margins, and expand indications.[2]

• Regulatory Approvals: Pending approvals for new formulations or combination protocols may catalyze market expansion.

• Global Oncology Burgeoning: Increasing AML incidence, notably in aging populations, enhances demand, especially in North America and Europe.

• Emerging Markets: Greater healthcare access and affordability in Asia-Pacific and Latin America could significantly broaden the drug’s geographic footprint.

Projected Revenue Trajectory

Based on current trajectories, the Idarubicin Hydrochloride market may grow at a CAGR of approximately 5-7% over the next decade. By 2030, its revenues could surpass USD 1.8 billion globally, driven by both generic sales and novel indications.

Challenges and Risks

• Resistance & Toxicity: Resistance development and cardiotoxicity pose ongoing hurdles despite formulation improvements.

• Market Competition: The rapid emergence of targeted therapies and immunotherapies in AML could impact demand for traditional anthracyclines.

• Regulatory Barriers: Approvals for new formulations or indications require robust clinical evidence, which can be resource-intensive.

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Conclusion

Idarubicin Hydrochloride Pfs stands at a pivotal juncture, with robust clinical trials exploring enhanced efficacy and safety profiles. The market outlook remains promising, buoyed by demographic trends, therapeutic innovations, and expanding clinical applications. However, challenges such as toxicity management and stiffening competition necessitate strategic development and positioning. Continuous innovation, particularly in formulation science and combination strategies, will be paramount in harnessing its full market potential.

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Key Takeaways

• Ongoing clinical trials aim to expand Idarubicin Hydrochloride's utility and improve safety profiles, focusing on combination therapies and novel formulations.
• The global AML treatment market is expanding, with Idarubicin maintaining a significant share due to its established efficacy.
• Advances in drug delivery technology and regulatory approvals could catalyze a shift toward broader indications and improved safety.
• Market growth is projected at a CAGR of 5-7%, with revenues potentially exceeding USD 1.8 billion by 2030.
• Strategic differentiation and innovation will be essential to confront resistance, toxicity concerns, and competitive pressures.

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FAQs

Q1: What are the main clinical uses of Idarubicin Hydrochloride?
A1: Primarily, it treats acute myeloid leukemia (AML), especially in remission induction protocols, often combined with cytarabine. Emerging trials also explore its efficacy in other hematologic malignancies.

Q2: How does Idarubicin compare to other anthracyclines?
A2: Idarubicin exhibits a favorable efficacy profile with potentially reduced cardiotoxicity compared to daunorubicin. Its pharmacokinetics allow for flexible dosing, and it demonstrates potent anti-leukemic activity.

Q3: What are the key challenges facing Idarubicin market growth?
A3: Toxicity concerns, resistance development, and stiff competition from targeted therapies and immunotherapies pose significant barriers.

Q4: Are there any FDA-approved new formulations of Idarubicin?
A4: As of now, no novel formulations have received full regulatory approval. However, nanoparticle and targeted delivery systems are progressing through development stages.

Q5: What potential does Idarubicin have in expanding beyond AML?
A5: Clinical trials are investigating its use in other hematological malignancies and combination therapies, which may diversely position the drug in oncology.

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Sources
[1] Global Market Insights, “Oncology Drugs Market Size & Trends,” 2022.
[2] Zhang, L., et al., “Nanoparticle Formulations for Targeted Chemotherapy,” Journal of Nanomedicine, 2021.