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.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	Medical Research Council	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	National Cancer Institute (NCI)	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	Eastern Cooperative Oncology Group	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
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.

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
Untreated Adult Acute Myeloid Leukemia	24

Condition MeSH

Condition MeSH for DAUNORUBICIN HYDROCHLORIDE
Intervention	Trials
Leukemia	318
Leukemia, Myeloid, Acute	228
Leukemia, Myeloid	195
Precursor Cell Lymphoblastic Leukemia-Lymphoma	128

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
Illinois	94
Ohio	94
Texas	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

Last updated: July 26, 2026

Daunorubicin Hydrochloride clinical trials update, market analysis, and market projection (2026–2036)

Daunorubicin hydrochloride remains a mature oncology cytotoxic, with clinical development activity concentrated in optimized dosing strategies, liposomal or formulation-adjacent delivery, and regimen-level comparisons in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Market dynamics are driven by (1) AML incidence and treatment intensity, (2) hospital procurement preferences for generic daunorubicin and branded supply reliability, and (3) substitution pressure from anthracycline alternatives and anthracycline-containing regimens using pegylated/liposomal carriers or different anthracyclines.

What clinical trials are updating daunorubicin hydrochloride in 2025–2026?

Snapshot: Trial updates for daunorubicin hydrochloride in this period are primarily regimen optimization (induction consolidation schedules, idarubicin vs daunorubicin comparisons, and sequencing with cytarabine), plus platform work where daunorubicin is used as a reference anthracycline arm rather than the novel investigational payload.

Which disease settings dominate recent daunorubicin hydrochloride trial activity?

• AML induction and consolidation: daunorubicin plus cytarabine remains a standard backbone in multiple comparator trials.
• ALL: less frequent, often in intensive chemotherapy regimen comparisons.
• Relapsed/refractory AML/ALL: more limited, frequently using daunorubicin as part of combination schedules rather than monotherapy.

What endpoints are being emphasized in current daunorubicin trials?

• Complete remission (CR) / complete remission with incomplete hematologic recovery (CRi)
• Overall survival (OS) and event-free survival (EFS)
• Relapse rate and duration of remission
• Treatment-related mortality
• Cardiotoxicity signals (left ventricular ejection fraction changes, cumulative anthracycline dose exposure)

What is the direction of results in regimen comparisons?

Where daunorubicin is directly compared to other anthracyclines, the recurring pattern is:

• modest differences in remission kinetics and tolerability
• survival impact tied to baseline risk stratification (cytogenetics, molecular markers) and delivery schedule rather than a uniform anthracycline superiority effect

What patents and IP still matter for daunorubicin hydrochloride today?

Snapshot: For daunorubicin hydrochloride, the active market is dominated by generics; clinical use is largely protected by old composition or formulation IP that has largely expired in most jurisdictions. Current IP value is typically in (1) specific formulations, (2) manufacturing processes, or (3) combination-regimen or protected dosing approaches when new exclusivities exist.

How does exclusivity typically work for an older anthracycline?

• Generic entry is common because the core active substance is not protected by long-lived active regulatory exclusivity.
• Residual IP can still exist around particular salt forms, particle-size specifications, lyophilized presentations, or stable reconstitution/manufacturing steps, depending on where a product is sourced.

Where do IP barriers show up in practice?

• Hospitals and wholesalers usually procure approved generics with bioequivalence.
• The IP barrier is less about “active substance patents” and more about variant presentations and supply chain continuity (qualified manufacturing sites, validated sterile fill-finish routes, stability for multi-dose handling).

What is the Orange Book status of daunorubicin hydrochloride?

Snapshot: Daunorubicin hydrochloride’s US approvals are predominantly generic; the FDA Orange Book listings typically show multiple abbreviated approvals for solid and/or sterile injectable presentations, with many older listings already past statutory exclusivity. The commercially relevant question usually shifts from exclusivity to label-specific manufacturing and product availability.

What listings tend to drive procurement decisions?

• Dosage form and strength (e.g., vial presentation suitable for ICU and infusion workflows)
• Storage/handling and reconstitution requirements
• Supply reliability and wholesaler availability
• Labeling that matches institution protocols for anthracycline dosing

How strong is the patent estate for daunorubicin hydrochloride versus generics?

Snapshot: Patent estate strength for daunorubicin hydrochloride as a substance is generally low versus modern standards, with litigation risk mainly tied to specific product presentations rather than the underlying API.

What types of patent claims can still matter?

• Manufacturing method patents for sterile injectable drug product
• Formulation patents for excipient system and stability
• Specific device-administration workflow if paired with a protected delivery system (rare for classic daunorubicin products)
• New use claims, which are uncommon as a practical lever unless tied to a specific protected protocol and the protocol was itself novel at the time of filing

Which companies control the daunorubicin hydrochloride market in the US and EU?

Snapshot: Market control is typically shared among multiple generic manufacturers and distributors. In mature injectable cytotoxics, leadership correlates with:

• qualified sterile manufacturing capacity
• continued supply through tenders
• ability to meet on-time DEA/controlled-handling requirements for oncology distribution networks

Market structure

• US: multiple ANDA products across strengths and packaging formats
• EU: national tender ecosystems and parallel procurement, with local MAHs and hospital purchasing groups

How big is the global daunorubicin hydrochloride market?

Snapshot: Daunorubicin hydrochloride is a niche within oncology injectables relative to monoclonals and targeted therapies, but it is high-volume within the cytotoxic AML backbone. Market value depends heavily on:

• price compression typical for generics
• intensity of AML treatment in major markets
• substitution patterns among anthracycline regimens

Market sizing logic used for projection (2026–2036):

• Base population: AML incident cases
• Treatment penetration: proportion treated with anthracycline-based induction
• Regimen share: daunorubicin-based vs other anthracycline-based backbones
• Utilization: dosing per induction/consolidation cycles and average cycles completed
• Pricing: generic net price trends and tender-driven changes

When does daunorubicin hydrochloride lose exclusivity for key product presentations?

Snapshot: For the active ingredient, exclusivity has largely expired. For specific presentations, exclusivity is usually tied to:

• first generic ANDA (older)
• reformulation or lifecycle changes that may carry limited periods of exclusivity

Practical answer: no single “exclusivity loss date” currently governs the whole market because the API is widely generic and multiple products already compete across years.

What generic entry risks exist for daunorubicin hydrochloride?

Snapshot: Generic entry risk is low for the core API because most jurisdictions already have multiple approved products. The realistic risks are:

• manufacturing site disruptions
• sterile fill-finish capacity constraints
• compliance lapses leading to FDA/EU quality holds
• demand spikes driven by AML incidence and protocol shifts

How does daunorubicin hydrochloride compare with idarubicin and other AML anthracyclines?

Snapshot: Daunorubicin is a standard comparator and backbone in AML, while idarubicin is often used as an alternative anthracycline. Clinical differentiation is usually protocol and patient-risk dependent rather than a universal efficacy gap.

What drives the choice between daunorubicin and idarubicin?

• institutional protocol history
• toxicity profile handling in local practice
• pharmacokinetics and clinician preference for remission kinetics
• drug acquisition economics

What formulation patents protect daunorubicin hydrochloride and its derivatives?

Snapshot: Formulation patents, where they exist, tend to cover:

• excipient systems affecting stability and reconstitution
• particle-size or solid-state properties for specific preparations
• shelf-life extension via processing changes

In general, these have limited impact on broad access because sterile injectable daunorubicin is widely generic. Lifecycle protection is more likely in specific countries or specific packaging and manufacturing routes.

What manufacturing and IP barriers affect daunorubicin hydrochloride supply?

Snapshot: The market risk profile is dominated by manufacturing and quality, not IP.

Common supply constraints

• sterile injectable batch failures
• stability/reconstitution specification compliance
• aseptic processing facility changes
• discontinuations during low-margin periods

How do clinical trial updates translate into market projection for 2026–2036?

Projection framework (what matters):

1. Stable clinical backbone: daunorubicin remains embedded in AML induction regimens, limiting downside demand.
2. Price erosion: sustained generic competition compresses net price.
3. Substitution: a shift toward alternative anthracyclines or specialized formulations can reduce share, but not remove the class.
4. Protocol variability: trial results often change clinical practice at the margin rather than replacing daunorubicin entirely.

Base case (most likely)

• Demand remains supported by AML chemotherapy intensity.
• Market value grows slowly, mostly from incidence-driven volume increases; net prices decline or remain flat.

Downside case

• Continued substitution toward alternative anthracyclines or regimen shifts reduces daunorubicin share.
• One or more manufacturing disruptions cause short supply shocks that raise prices temporarily but do not fix long-term share loss.

Upside case

• Trial-proven regimen refinements increase uptake of daunorubicin-based protocols in specific AML risk subgroups.
• Supply normalization in major tenders stabilizes net pricing.

2026–2036 market projection (US + EU/G7 approach)

Snapshot: A realistic projection for daunorubicin hydrochloride is low single-digit CAGR in value with moderate volume stability to growth driven by AML incidence and treatment intensity, offset by persistent generic price compression.

Key drivers by lever

• Volume: AML incidence growth plus higher treatment rates in some markets
• Price: continued tender-driven reductions, periodic supply disruptions
• Share: gradual substitution toward other anthracyclines and non-anthracycline regimens in certain protocols
• Policy and reimbursement: oncology drug formularies and hospital procurement rules

How do biosimilar and biologic pipelines affect daunorubicin hydrochloride demand?

Snapshot: Biosimilars do not directly replace cytotoxic daunorubicin, but broader AML treatment evolution (for example, targeted agents used in combination regimens) can change induction intensity and chemotherapy cycles. The impact is indirect and tends to shift share rather than eliminate use.

Key takeaways

• Daunorubicin hydrochloride clinical development focus remains regimen optimization in AML and comparator studies rather than new monotherapy breakthroughs.
• The market is structurally generic, so exclusivity and patent leverage are limited to presentation-specific or manufacturing/formulation lifecycle IP.
• Market growth is mainly volume-driven with modest value expansion because price compression persists.
• Competitive pressure comes from regimen substitution among anthracyclines and chemistry class shifts, plus manufacturing quality continuity that can affect supply and pricing.

FAQs

1. Is daunorubicin hydrochloride still the standard induction drug in AML?
2. What clinical endpoints matter most when evaluating daunorubicin-based AML regimens?
3. Do manufacturing supply issues have a bigger impact on daunorubicin market pricing than IP?
4. How do anthracycline substitutions (idarubicin, others) change daunorubicin utilization?
5. What hospital procurement factors most affect which daunorubicin hydrochloride generic is selected?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. Daunorubicin hydrochloride search results. National Library of Medicine.
3. EMA. European Public Assessment Reports (EPAR) and product information for daunorubicin-containing medicinal products. European Medicines Agency.