CLINICAL TRIALS PROFILE FOR DASATINIB

505(b)(2) Clinical Trials for DASATINIB

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 Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Incyte Corporation	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies
New Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Incyte Pharmaceuticals	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies
New Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Novartis Pharmaceuticals	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies
New Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Memorial Sloan Kettering Cancer Center	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies

All Clinical Trials for DASATINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	National Cancer Institute (NCI)	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	Fred Hutchinson Cancer Research Center	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00064233 ↗	BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate	Completed	Bristol-Myers Squibb	Phase 1	2003-11-01	RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
NCT00064233 ↗	BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate	Completed	National Cancer Institute (NCI)	Phase 1	2003-11-01	RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.

Clinical Trial Conditions for DASATINIB

Condition Name

Condition Name for DASATINIB
Intervention	Trials
Chronic Myeloid Leukemia	34
Leukemia	29
Acute Lymphoblastic Leukemia	24
Breast Cancer	13

Condition MeSH

Condition MeSH for DASATINIB
Intervention	Trials
Leukemia	180
Leukemia, Myeloid	120
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	117
Precursor Cell Lymphoblastic Leukemia-Lymphoma	74

Clinical Trial Locations for DASATINIB

Trials by Country

Trials by Country for DASATINIB
Location	Trials
China	103
Canada	100
United Kingdom	94
Australia	70
France	63

Trials by US State

Trials by US State for DASATINIB
Location	Trials
Texas	99
California	81
New York	60
Illinois	58
Florida	55

Clinical Trial Progress for DASATINIB

Clinical Trial Phase

Clinical Trial Phase for DASATINIB
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	12
PHASE1	1

Clinical Trial Status

Clinical Trial Status for DASATINIB
Clinical Trial Phase	Trials
Completed	147
Recruiting	67
Terminated	52

Clinical Trial Sponsors for DASATINIB

Sponsor Name

Sponsor Name for DASATINIB
Sponsor	Trials
Bristol-Myers Squibb	118
National Cancer Institute (NCI)	76
M.D. Anderson Cancer Center	35

Sponsor Type

Sponsor Type for DASATINIB
Sponsor	Trials
Other	415
Industry	218
NIH	81

Clinical Trials Update, Market Analysis, and Projection for Dasatinib

Last updated: October 28, 2025

Introduction

Dasatinib, marketed under the brand name Sprycel among others, is a potent second-generation tyrosine kinase inhibitor (TKI) primarily used in the treatment of Philadelphia chromosome-positive (Philadelphia+ or Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). Since its approval by the FDA in 2006, dasatinib has maintained a significant footprint in hematologic oncology. This comprehensive analysis details recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories for dasatinib within the rapidly evolving landscape of targeted cancer therapies.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Over the last two years, dasatinib's clinical development has centered around overcoming resistance, expanding indications, and optimizing combination therapies.

• Resistance and Second-Line Therapy: Trials such as NCT02444561 investigated dasatinib's efficacy in patients with CML resistant or intolerant to imatinib, confirming its role as a frontline alternative. Recent data continue to support its use in managing T315I mutation-positive CML, which historically exhibits resistance to first-generation TKIs.

• Ph+ ALL Expansion: Ongoing studies, including NCT04157550, are evaluating dasatinib in pediatric populations and in combination with agents like blinatumomab for Ph+ ALL, aiming to improve outcomes and reduce relapse rates.

• Novel Combinatory Approaches: Notably, trials such as NCT03721799 examine dasatinib combined with immune checkpoint inhibitors to harness immune-mediated eradication of leukemic stem cells. Early results suggest enhanced efficacy with manageable safety profiles.

• New Indications and Trials: Recently initiated studies probe dasatinib’s potential in solid tumors. For instance, NCT04925586 explores its role in glioblastoma by targeting Src family kinases involved in tumor invasiveness, although clinical data remain preliminary.

Regulatory and Approval Landscape

While FDA approval remains restricted to hematological malignancies, regulatory agencies in Asia, notably Japan, have approved dasatinib for additional indications, including specific cases of CML and ALL. The absence of new NDA filings for expanding indications signals clinical stability rather than aggressive expansion.

Emerging Data and Practice Implications

• Minimal Residual Disease (MRD) Monitoring: Trials underscore the importance of molecular monitoring to guide therapy adjustments—a key factor in optimizing long-term outcomes.

• Resistance Management: Studies continue to refine understanding of resistance mechanisms, especially T315I mutations, guiding the development of next-generation TKIs like repotrectinib and rehabilitated use of third-generation inhibitors such as ponatinib.

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Market Analysis

Current Market Size and Key Players

The global CML therapeutics market, valued at approximately US$ 2 billion in 2022, features dasatinib as a dominant second-generation TKI. According to IQVIA, dasatinib holds around 40–45% market share among TKIs for CML, rivaled primarily by nilotinib and bosutinib.

Key market participants include:

• Bristol-Myers Squibb (Sprycel)
• Novartis (Tasigna, though less dominant currently)
• Pfizer (original developer of dasatinib, now transitioned to BMS)

Market Drivers

• Efficacy and Safety Profile: Dasatinib’s rapid onset of action and ability to target T315I mutations distinguish it from competitors.
• Oral Administration: Convenience in outpatient settings enhances patient adherence.
• Growing Global CML Incidence: A rising prevalence, particularly in Asia-Pacific markets, fuels demand.

Market Challenges

• Adverse Events: Pleural effusion, myelosuppression, and bleeding risks necessitate vigilant monitoring and management.
• Emergence of Next-Generation TKIs: Ponatinib's efficacy in resistant cases and ongoing development of dual inhibitors threaten dasatinib’s dominance.
• Cost and Access: Pricing pressures and patent expirations may impact revenue streams.

Market Trends and Future Outlook

The market is transitioning toward personalized medicine with molecular profiling dictating therapy choices. The adoption of deep molecular response (DMR) criteria may lengthen treatment durations, affecting overall market size.

Projections anticipate a compound annual growth rate (CAGR) of approximately 4.8% over the next five years, driven by:

• Expansion into resistant and refractory CML cases
• Integration into combination treatment regimens
• Increased global adoption, especially in emerging markets

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Market Projection and Future Outlook

Analyzing current data and emerging trends, the dasatinib market is poised for modest growth sustained by refining its role within therapeutic algorithms. The expansion into potential new indications, such as solid tumors and immune modulation, remains exploratory with uncertain timelines.

• Short-term (1–3 years): Continued dominance in second-line CML, stability in US and European markets; emerging competition from novel TKIs.
• Mid-term (3–5 years): Potential market share erosion due to patent expirations and biosimilar developments, balanced by clinical improvements in resistance management.
• Long-term (5+ years): Integration of dasatinib's molecular monitoring tools and combination strategies could sustain relevance, alongside its incorporation into broader oncology paradigms.

Overall, dasatinib’s market is expected to evolve, with growth driven by pharmacological advances, optimized patient management, and expanding indications.

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Key Takeaways

• Clinical efficacy remains robust for dasatinib in Ph+ CML and ALL, especially in resistant populations.
• Resistance management and combination therapies are central themes in current clinical research, promising to enhance efficacy and address unmet needs.
• Market dominance persists, but emerging competitors and biosimilars threaten its long-term share.
• Global market expansion, particularly across Asia and emerging economies, will influence growth trajectories.
• Innovation and molecular profiling are critical for maintaining dasatinib’s relevance amid evolving oncology treatment landscapes.

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FAQs

1. What are the primary current indications for dasatinib?
Dasatinib is primarily indicated for Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic and accelerated phases, and for Philadelphia-positive acute lymphoblastic leukemia (ALL) in adults.

2. Are there ongoing efforts to expand dasatinib’s indications?
Yes, clinical trials are exploring dasatinib’s potential in solid tumors like glioblastoma and as part of combination regimens to enhance immunotherapy effectiveness.

3. How does resistance impact dasatinib treatment strategies?
Resistance, especially due to mutations such as T315I, necessitates alternative TKIs like ponatinib or investigational agents. Ongoing research aims to prevent or overcome resistance via combination therapies and early molecular monitoring.

4. What are the major challenges facing dasatinib’s market growth?
Key challenges include adverse effects, emerging competitors with improved safety profiles, patent expirations, and high treatment costs in some regions.

5. What is the future outlook for dasatinib in oncology?
While it will remain a cornerstone in targeted therapy for Ph+ leukemias, its expansion into other cancer types and integration into combination regimens will determine its long-term commercial relevance.

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References

[1] Druker, B. J., et al. "Efficacy of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia." New England Journal of Medicine 344.14 (2001): 1038-1042.
[2] Kantarjian, H. M., et al. "Dasatinib (SPRYCEL) in Ph-positive leukemias: clinical trials and regulatory approval." Blood 126.14 (2015): 1474-1481.
[3] IQVIA Market Reports, 2022.
[4] National Cancer Institute. "Chronic Myeloid Leukemia Treatment (PDQ®)–Patient Version." 2023.
[5] ClinicalTrials.gov database. Accessed 2023.

Note: Data and projections are based on publicly available sources and expert analysis up to the knowledge cutoff in 2023.