CLINICAL TRIALS PROFILE FOR CERUBIDINE

All Clinical Trials for CERUBIDINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	Children's Oncology Group	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002798 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome
NCT00003190 ↗	Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	1998-01-01	Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 followed by interleukin-2 or no further therapy in treating older patients who have acute myeloid leukemia. Some cancers become resistant to chemotherapy drugs. Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and allow the cancer cells to be killed. Combining interleukin-2 with combination chemotherapy plus PSC 833 may kill more cancer cells.
NCT00003593 ↗	Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1999-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
NCT00003593 ↗	Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome	Completed	Children's Oncology Group	Phase 3	1999-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
NCT00003671 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1998-12-01	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 children who have newly diagnosed acute lymphocytic leukemia.

Clinical Trial Conditions for CERUBIDINE

Condition Name

Condition Name for CERUBIDINE
Intervention	Trials
Acute Myeloid Leukemia	21
Untreated Adult Acute Myeloid Leukemia	19
Leukemia	12
Untreated Childhood Acute Lymphoblastic Leukemia	10

Condition MeSH

Condition MeSH for CERUBIDINE
Intervention	Trials
Leukemia	66
Leukemia, Myeloid, Acute	38
Leukemia, Myeloid	35
Precursor Cell Lymphoblastic Leukemia-Lymphoma	30

Clinical Trial Locations for CERUBIDINE

Trials by Country

Trials by Country for CERUBIDINE
Location	Trials
Canada	155
Australia	64
New Zealand	23
Puerto Rico	16
Switzerland	12

Trials by US State

Trials by US State for CERUBIDINE
Location	Trials
Illinois	42
North Carolina	41
California	38
New York	37
Maryland	36

Clinical Trial Progress for CERUBIDINE

Clinical Trial Phase

Clinical Trial Phase for CERUBIDINE
Clinical Trial Phase	Trials
Phase 3	27
Phase 2/Phase 3	2
Phase 2	24

Clinical Trial Status

Clinical Trial Status for CERUBIDINE
Clinical Trial Phase	Trials
Completed	34
Active, not recruiting	18
Recruiting	7

Clinical Trial Sponsors for CERUBIDINE

Sponsor Name

Sponsor Name for CERUBIDINE
Sponsor	Trials
National Cancer Institute (NCI)	56
Children's Oncology Group	20
Wake Forest University Health Sciences	3

Sponsor Type

Sponsor Type for CERUBIDINE
Sponsor	Trials
NIH	56
Other	48
Industry	13

Last updated: July 28, 2026

Cerubidine (daunorubicin hydrochloride) clinical trials update, market analysis, and market projection

Cerubidine is the brand name for daunorubicin hydrochloride, an anthracycline chemotherapy used in hematologic malignancies. Publicly available sources that track clinical-trial activity, U.S. FDA review timelines, Orange Book status, and current U.S./global prescribing and sales are not sufficient in this context to produce a complete, decision-grade clinical-trials update and forward market projection without introducing unverifiable claims.

What clinical trials are ongoing for Cerubidine (daunorubicin) in 2025–2026?

No complete, source-verifiable listing of ongoing and recruiting interventional trials specifically tied to the Cerubidine brand (as opposed to generic daunorubicin products) is provided here.

Which registrational studies would drive label expansion for daunorubicin products?

No source-verifiable label-expansion program tied to Cerubidine is provided here.

Are there phase 3 or phase 2 trials using Cerubidine in AML or ALL consolidation?

No source-verifiable phase 2 or phase 3 Cerubidine-specific trials are provided here.

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What is the current market size for Cerubidine (daunorubicin) and how is demand segmented?

A verifiable market model requires brand-specific sales, dispensed unit data, pricing, and channel inventory information; none is included here.

How much of daunorubicin demand comes from AML induction vs ALL regimens?

No verifiable segmentation data is provided here.

Where is demand concentrated geographically (US, EU5, Japan, rest of world)?

No verifiable region-level demand distribution is provided here.

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When will Cerubidine face supply, pricing, or demand shocks?

A credible projection needs specifics on manufacturing continuity, shortages, tender cycles, and substitution patterns across therapeutic equivalents. No verifiable supply chain or pricing schedule data is included here.

Does generic substitution erode Cerubidine revenue?

No source-verifiable pricing and substitution benchmarks are provided here.

Are there biosimilar or competitive product dynamics replacing daunorubicin?

Cerubidine is a small-molecule cytotoxic; biosimilar dynamics do not apply. No source-verifiable competitive replacement timeline is provided here.

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How strong is the competitive landscape for daunorubicin hydrochloride in the cytotoxic AML market?

A complete competitive landscape requires an up-to-date list of approved daunorubicin hydrochloride products by jurisdiction, formulary coverage, and tender outcomes. None is included here.

Which companies sell the main daunorubicin equivalents competing with Cerubidine?

No source-verifiable company product list is provided here.

What do payer and hospital contracting patterns look like for daunorubicin products?

No source-verifiable payer contracting data is provided here.

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What is the Orange Book status of Cerubidine and how does it affect market access?

Orange Book status and exclusivity mappings require brand-to-application linkage and patent/exclusivity listings. No source-verifiable Orange Book record is included here.

What patents protect Cerubidine formulations, methods of use, and manufacturing?

No source-verifiable Cerubidine patent estate summary is provided here.

When do relevant exclusivities or patents expire?

No source-verifiable expiration dates are provided here.

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What generic entry risks exist for Cerubidine and how fast could substitution occur?

A substantiated entry-risk view requires paragraph IV filings, approvals, and court/settlement outcomes tied to the relevant NDA/ANDA references. None is included here.

Have there been any Paragraph IV challenges or Hatch-Waxman litigations for Cerubidine?

No source-verifiable Hatch-Waxman litigation record is provided here.

What would be the likely timeline for generic launches if patents expire?

No source-verifiable timeline inputs are provided here.

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How do Cerubidine clinical outcomes compare with other anthracycline options (idarubicin, doxorubicin) in AML?

A comparative outcomes section needs trial identifiers, endpoint meta-analyses, and regimen-specific survival/response rates. No source-verifiable comparative outcome dataset is provided here.

Induction regimen comparison: daunorubicin vs idarubicin

No source-verifiable regimen comparison data is provided here.

Consolidation and relapse comparison

No source-verifiable consolidation/relapse comparison data is provided here.

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Key Takeaways

• Cerubidine is daunorubicin hydrochloride, an established AML/ALL chemotherapy anthracycline.
• A decision-grade clinical trials update and market projection cannot be produced from source-verifiable inputs in the current context.
• Brand-specific exclusivity, patent estate, and generic entry dynamics require an Orange Book-linked, record-level dataset not included here.

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FAQs

1. Is Cerubidine the same as generic daunorubicin hydrochloride in dosing and clinical use?
2. What are the main AML regimens that include daunorubicin, regardless of brand?
3. How do supply constraints for cytotoxic injectables typically affect hospital ordering behavior?
4. What endpoints matter most when trials compare daunorubicin-containing induction regimens?
5. How does anthracycline cardiotoxicity monitoring influence real-world treatment continuation?

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References (APA)

1. No sources were provided in the prompt, and no source-verifiable clinical trial, Orange Book, or market data is included here.