CLINICAL TRIALS PROFILE FOR DAUNORUBICIN HYDROCHLORIDE

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).

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.

Clinical Trial Conditions for daunorubicin hydrochloride

Condition Name

Condition Name for daunorubicin hydrochloride
Intervention	Trials
Acute Myeloid Leukemia	116
Leukemia	88
Acute Lymphoblastic Leukemia	34

Condition MeSH

Condition MeSH for daunorubicin hydrochloride
Intervention	Trials
Leukemia	318
Leukemia, Myeloid, Acute	228
Leukemia, Myeloid	195

Clinical Trial Locations for daunorubicin hydrochloride

Trials by Country

Trials by Country for daunorubicin hydrochloride
Location	Trials
Canada	250
China	98
Japan	72
Spain	70
Germany	59

Trials by US State

Trials by US State for daunorubicin hydrochloride
Location	Trials
California	105
New York	103
Ohio	94
Texas	94
Illinois	94

Clinical Trial Progress for daunorubicin hydrochloride

Clinical Trial Phase

Clinical Trial Phase for daunorubicin hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	7
PHASE2	20

Clinical Trial Status

Clinical Trial Status for daunorubicin hydrochloride
Clinical Trial Phase	Trials
Completed	167
Recruiting	97
Active, not recruiting	42

Clinical Trial Sponsors for daunorubicin hydrochloride

Sponsor Name

Sponsor Name for daunorubicin hydrochloride
Sponsor	Trials
National Cancer Institute (NCI)	129
Children's Oncology Group	35
Jazz Pharmaceuticals	20

Sponsor Type

Sponsor Type for daunorubicin hydrochloride
Sponsor	Trials
Other	449
Industry	148
NIH	132

Daunorubicin Hydrochloride: Clinical Trials Update and Market Outlook

Last updated: April 26, 2026

What is daunorubicin hydrochloride’s clinical and regulatory footprint?

Daunorubicin hydrochloride is a naturally derived anthracycline used in acute leukemia treatment, most notably acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) in combination regimens. It is widely positioned in practice and in clinical development as a backbone cytotoxic rather than a platform candidate.

Core clinical positioning (industry-standard use)

• Induction therapy in AML: daunorubicin is used as part of induction regimens commonly combined with cytarabine.
• Consolidation and re-induction: use varies by country protocol and risk stratification.

What “clinical trials update” means for a mature drug

For established cytotoxics, active trials tend to concentrate in:

• Comparative regimen studies (dose, schedule, combination partners)
• New routes/formulations (less frequent but present)
• Population and supportive-care outcomes (cardiotoxicity mitigation, response depth)

No specific, reliable, current trial phase-by-phase dataset can be produced from the information provided in this request alone. A complete, accurate update requires a live registry pull (e.g., ClinicalTrials.gov/WHO ICTRP) and dated record matching.

Where does the market sit today?

Daunorubicin hydrochloride is typically sold as:

• Generic or originator products in hospital procurement channels
• Low-margin but high-volume in segments tied to leukemia induction protocols

A precise market size, share, and country-level procurement mix cannot be computed without a dated market dataset. A complete and accurate projection also requires information that is not included in the request: current sales by geography, molecule-level pricing trends, and biosimilar or competitor displacement.

The drug is mature and off-patent in most major jurisdictions, which shifts the market model from patent-led growth to protocol and price dynamics. That means the primary market drivers are:

• AML incidence and treatment intensity (patient volume)
• Hospital formularies and protocol adherence
• Generic pricing cycles and tender cycles
• Supportive care and toxicity management practices that influence regimen choice

What drives demand and pricing for daunorubicin hydrochloride?

Demand drivers:

1. AML treatment volume: daunorubicin is a recurring induction component.
2. Protocol choices: different induction schemas (dose bands, timing with cytarabine) affect utilization intensity.
3. Switching to alternatives: daunorubicin uptake can decline where institutional practice shifts to other anthracyclines or protocol variants.

Pricing drivers:

1. Generic competition: multiple manufacturers typically compress net pricing.
2. Tender-based contracting: hospital procurement can produce abrupt price drops.
3. Supply continuity: shortages can temporarily lift prices and reorder patterns.

How should a market projection be constructed for 3-5 years?

A defensible projection for a mature cytotoxic should be built from a “protocol-volume-pricing” bridge:

• Protocol volume: expected AML patient treated in relevant settings
• Penetration: share of regimens that include daunorubicin
• Dose intensity and regimen duration: impacts drug units per patient
• Net price: generic tender effects and cost inflation pass-through

A numeric forecast cannot be produced from the request because the required baseline series (current market revenue/units, geography mix, and price trend) is not included.

If you need an actionable forecast, the only route is to anchor to a specific market model dataset (e.g., IQVIA/GlobalData, or a consistent oncology cytotoxic pack-size procurement dataset) and then apply protocol penetration assumptions. Without those inputs, any numeric projection would be non-verifiable.

What is the patent and exclusivity posture?

Daunorubicin hydrochloride’s availability in multiple jurisdictions as a standard chemotherapy strongly indicates active patent protection is not the primary commercial lever in the modern market. Commercial durability comes from:

• Long-running inclusion in clinical protocols
• Formulary inertia in hospital procurement
• Generic manufacturing footprint

A precise patent or exclusivity map requires jurisdiction-by-jurisdiction legal data retrieval. That cannot be completed from the information provided in the prompt.

Clinical trials: where are updates most likely to appear?

For daunorubicin, the most common new trial categories that move clinical practice are:

• Dose optimization and schedule comparisons within standard induction therapy
• Combination optimization with newer agents (where allowed by trial design)
• Toxicity reduction strategies, particularly cardiac safety monitoring and supportive care

However, an “update” with current phase status, enrollment, endpoints, and readout dates requires a live registry pull and date filtering.

Actionable business takeaways

Key decision points for R&D and investment

• Regulatory strategy: for a mature ingredient, differentiation must come from formulation, delivery, combination strategy, or patient-selection rather than “new molecule” claims.
• Commercial strategy: evaluate growth primarily through protocol adherence and tender-driven pricing resilience, not exclusivity.
• Clinical strategy: trial designs that can shift dosing or regimen selection produce the highest adoption impact.

Key Takeaways

1. Daunorubicin hydrochloride is a mature AML cytotoxic with demand tied to induction protocol use and generic pricing cycles.
2. A current, accurate “clinical trials update” and a numeric “market projection” cannot be generated without a dated trial registry dataset and baseline market/pricing inputs.
3. In this category, meaningful R&D value usually comes from regimen-optimization evidence, toxicity management, or formulation advantages that affect adoption and procurement.

FAQs

1. What cancers use daunorubicin hydrochloride most often?
   It is most commonly used for acute leukemia treatment, especially AML, typically in combination induction regimens.

2. Is daunorubicin hydrochloride still under strong patent protection?
   Market behavior and widespread availability suggest patent exclusivity is not the dominant commercial driver in most markets.

3. What types of trials most commonly include daunorubicin?
   Regimen comparisons, dose/schedule optimization, combination studies, and supportive care or toxicity-management endpoints.

4. What market forces matter most for daunorubicin generics?
   Hospital tenders, generic manufacturer competition, and protocol adherence drive net pricing and volume.

5. What is the best path to commercial differentiation?
   Evidence that changes standard practice, improves tolerability, or reduces overall treatment burden, typically through formulation or regimen optimization rather than molecule novelty.

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References

[1] National Cancer Institute. “Daunorubicin.” Cancer.gov. https://www.cancer.gov/ (accessed 2026-04-26).
[2] U.S. Food and Drug Administration. “Daunorubicin.” Drug approvals and labels (via Drugs@FDA). https://www.accessdata.fda.gov/ (accessed 2026-04-26).
[3] World Health Organization. “WHO Model List of Essential Medicines: Daunorubicin.” https://www.who.int/ (accessed 2026-04-26).