CLINICAL TRIALS PROFILE FOR IDAMYCIN

All Clinical Trials for Idamycin

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.

Clinical Trial Conditions for Idamycin

Condition Name

Condition Name for Idamycin
Intervention	Trials
Leukemia	14
Acute Myeloid Leukemia	8
Untreated Adult Acute Myeloid Leukemia	5
High Risk Myelodysplastic Syndrome	3

Condition MeSH

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

Clinical Trial Locations for Idamycin

Trials by Country

Trials by Country for Idamycin
Location	Trials
United States	178
Canada	15
Australia	7
China	3
Puerto Rico	2

Trials by US State

Trials by US State for Idamycin
Location	Trials
Texas	19
California	10
Missouri	7
Washington	6
North Carolina	6

Clinical Trial Progress for Idamycin

Clinical Trial Phase

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

Clinical Trial Status

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Withdrawn	3

Clinical Trial Sponsors for Idamycin

Sponsor Name

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

Sponsor Type

Sponsor Type for Idamycin
Sponsor	Trials
Other	35
NIH	16
Industry	11

Idamycin (Idarubicin Hydrochloride): Clinical Trials, Market Analysis, and Projections

Introduction to Idarubicin

Idarubicin, marketed as Idamycin PFS®, is a chemotherapeutic agent primarily used in the treatment of acute myeloid leukemia (AML). It belongs to the anthracycline class of drugs, which work by interfering with DNA replication, thereby inhibiting the growth of cancer cells.

Clinical Trials and Efficacy

Current Clinical Trials

Idarubicin has been extensively studied in various clinical trials, particularly in combination with other chemotherapeutic agents like cytarabine. For instance, a pilot clinical trial (NCT01822015) investigated the combination of sirolimus, idarubicin, and cytarabine in treating newly diagnosed AML patients. This trial aimed to determine if the addition of sirolimus could enhance the efficacy of idarubicin and cytarabine by blocking certain enzymes necessary for cell growth[4].

In controlled clinical trials worldwide, approximately 550 patients with AML have received idarubicin in combination with cytarabine. These trials have shown promising results, with complete remission rates and median survival times that are comparable to, or in some cases better than, those achieved with other anthracyclines like daunorubicin[1].

Efficacy and Safety Profile

The efficacy of idarubicin is well-documented. In U.S. clinical trials, idarubicin administered at 12 mg/m² daily for 3 days in combination with cytarabine resulted in complete remission rates of up to 78% in patients aged 60 years or less. The median survival for these patients was around 508 days, highlighting the drug's effectiveness in AML treatment[1].

However, idarubicin also comes with a significant side effect profile, which includes myelosuppression, cardiotoxicity, and other adverse effects common to anthracyclines. The contribution of idarubicin to these adverse experiences can be challenging to establish due to the complex treatment regimens and the severe illness of the patients[1].

Market Analysis

Market Size and Growth

The market for idarubicin hydrochloride for injection is part of the broader acute myeloid leukemia therapeutics market, which is expected to grow significantly. The AML therapeutics market is projected to reach $2.97 billion by 2029, growing at a CAGR of 10.15% from 2024 to 2029. This growth is driven by the increasing incidence and prevalence of AML, advancements in pharmacology and molecular biology, and rising investments in research and development[3].

Market Segmentation

The idarubicin market can be segmented by product form, distribution channel, end-user, and route of administration. Idarubicin is available in various forms, including combination kits, lyophilized powder, and solution. It is primarily distributed through hospitals, oncology clinics, and online pharmacies. The drug is administered intravenously, which is the dominant route of administration for AML therapeutics[2].

Market Drivers

Key drivers of the idarubicin market include the increasing incidence of AML, advancements in drug delivery systems, and growing investments in healthcare infrastructure and research. The rising demand for effective cancer treatments, especially in emerging economies, also contributes to market growth. Additionally, strategic partnerships and collaborations in research are crucial for overcoming market challenges and enhancing product development pipelines[2].

Market Restraints

Despite the growth potential, the idarubicin market faces several challenges. These include stringent regulatory requirements, potential side effects, and high development and administration costs. Competition from newer targeted therapies and generic alternatives also poses a significant threat. Furthermore, intellectual property and licensing fees can be a barrier for new market entrants[2].

Market Projections

Future Outlook

The idarubicin hydrochloride for injection market is expected to continue growing, driven by the increasing need for effective AML treatments. Here are some key projections:

• Market Size: The AML therapeutics market, which includes idarubicin, is forecast to reach $18.3 billion by 2026, growing at a CAGR of 7.2% from 2021 to 2026[5].
• Emerging Markets: There is substantial room for market expansion into emerging economies where the demand for cancer treatments is rising. This expansion is expected to drive growth in the idarubicin market[2].
• Innovation and R&D: Research focused on precision medicine, patient-centric care models, and advancements in drug delivery systems will be crucial for enhancing the efficacy and safety profile of idarubicin. This could include formulating idarubicin with reduced toxicity or combining it with novel agents[2].

Key Takeaways

• Clinical Efficacy: Idarubicin has shown significant efficacy in treating AML, particularly when combined with cytarabine.
• Market Growth: The idarubicin market is driven by increasing AML incidence, advancements in pharmacology, and growing investments in healthcare.
• Challenges: The market faces challenges such as regulatory hurdles, side effects, and competition from newer therapies.
• Future Outlook: The market is expected to grow, with opportunities in emerging economies and through innovations in drug delivery and combination therapies.

FAQs

What is idarubicin used for?

Idarubicin is primarily used in the treatment of acute myeloid leukemia (AML), often in combination with other chemotherapeutic agents like cytarabine.

What are the common side effects of idarubicin?

Common side effects include myelosuppression, cardiotoxicity, and other adverse effects typical of anthracyclines.

How is idarubicin administered?

Idarubicin is administered intravenously, typically as part of an induction therapy regimen for AML.

What is the market outlook for idarubicin?

The market for idarubicin is expected to grow, driven by increasing AML incidence and advancements in healthcare. However, it faces challenges such as regulatory hurdles and competition from newer therapies.

Are there ongoing clinical trials involving idarubicin?

Yes, there are ongoing and completed clinical trials investigating idarubicin in combination with other agents, such as sirolimus and cytarabine, to enhance its efficacy in treating AML.

Sources

1. Pfizer: Idamycin PFS® idarubicin hydrochloride injection.
2. 360 Research Reports: Idarubicin Hydrochloride for Injection Market Size 2025-2030.
3. GlobeNewswire: Acute Myeloid Leukemia Market Size Expected to Reach $2.97 Billion By 2029.
4. My Cancer Genome: Clinical Trial: NCT01822015.
5. IndustryARC: Acute Myeloid Leukemia Therapeutics Market - Forecast(2025.