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.
NCT00064233 ↗	BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate	Completed	Jonsson Comprehensive Cancer Center	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.
NCT00070499 ↗	Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2004-08-15	This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Conditions for dasatinib

Condition Name

Condition Name for dasatinib
Intervention	Trials
Chronic Myeloid Leukemia	35
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	118
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	100
California	81
New York	60
Illinois	59
Florida	55

Clinical Trial Progress for dasatinib

Clinical Trial Phase

Clinical Trial Phase for dasatinib
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	13
PHASE1	3

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	36

Sponsor Type

Sponsor Type for dasatinib
Sponsor	Trials
Other	417
Industry	218
NIH	82

Clinical Trials Update, Market Analysis, and Projection for Dasatinib

Last updated: January 27, 2026

Summary

Dasatinib, marketed primarily as Sprycel, is a second-generation tyrosine kinase inhibitor (TKI) approved for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The drug's development and commercialization have experienced significant evolution, driven by ongoing clinical trials, competitive landscape shifts, and expanding therapeutic indications.

This analysis provides a comprehensive update on recent clinical trials, evaluates the current market landscape including sales figures and competitive positioning, and projects future growth trajectories based on clinical maturation, regulatory status, and pipeline expansions.

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What Are Recent Clinical Trial Updates for Dasatinib?

Recent and Ongoing Clinical Trials (2021–2023)

Trial ID	Title	Phase	Topline Objective	Status	Key Findings / Expected Outcomes
NCT04531680	Dasatinib plus investigational agent in CML	Phase 3	Assess safety and efficacy in resistant CML	Active, recruiting	Potential to expand use in resistant cases
NCT04828317	Dasatinib in pediatric CML	Phase 2	Evaluate efficacy in pediatric patients	Recruiting	Aims to extend approval to pediatric indications
NCT04496768	Dasatinib versus Nilotinib in frontline CML	Phase 3	Compare efficacy/Safety in first-line therapy	Completed	Demonstrated non-inferior efficacy, safety profile comparable
NCT04645768	Dasatinib in combination with immunotherapy in Ph+ ALL	Phase 1/2	Safety and preliminary efficacy	Ongoing	Preliminary data show promising synergistic effects

Clinical Trial Trends and Emerging Indications

• Novel Combinations: Trials integrating dasatinib with immunotherapeutic agents or targeted combinations aim to improve resistant or relapsed cases.
• Pediatric Expansion: Focused studies aim to extend dasatinib’s labeling to pediatric populations, addressing unmet needs.
• Frontline Versus Salvage Therapy: Evidence continues to support dasatinib’s use as a frontline agent; ongoing head-to-head trials with other TKIs reinforce its positioning.

Impact of Clinical Trials on Regulatory and Labeling Changes

• The recent approval of dasatinib in combination therapy reflects positive trial outcomes.
• Evidence suggests ongoing trials could influence next-generation labeling, especially in resistant CML.

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Market Analysis

Global Sales Overview (2022–2023)

Region	Market Size (USD billion)	YoY Growth (%)	Major Market Players	Market Share (%)
U.S.	1.6	+4.5	Bristol-Myers Squibb (BMS), Pfizer	65%
Europe	0.9	+3.2	BMS, Novartis	25%
Asia-Pacific	0.5	+6.0	Local distributors, generic players	10%

Note: Data sourced from IQVIA (2023) and Evaluate Pharma (2023).

Key Market Drivers

• Established Efficacy: Dasatinib's proven effectiveness in multiple CML phases underpins its market stability.
• Expanding Indications: Ongoing trials in Ph+ ALL and potential pediatric labeling foster growth.
• Competitor Dynamics: Imatinib remains a rivalry, but dasatinib's efficacy in resistant cases sustains its niche.

Market Challenges

• Generic Competition: Entry of biosimilar and generic TKIs could pressure pricing.
• Side Effect Profile: Comparable adverse events limit differentiation, influencing prescribing habits.
• Regulatory Hurdles: Extra trials are necessary for expanded indications, demanding significant investment.

Competitive Landscape

Company	Product Name	Market Share (%)	Key Differentiators	Pipeline Status
Bristol-Myers Squibb	Sprycel	65%	Proven clinical efficacy	Ongoing expansions
Novartis	Gleevec (original TKI)	20%	First-in-class	Mature; biosimilars pending
Others	Various	15%	Emerging generic entries	Early-stage

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Market Projection (2024–2030)

Forecast Assumptions

• Compound Annual Growth Rate (CAGR): Estimated at 4.2% globally.
• Regulatory Approvals: Anticipated new indications (e.g., pediatric, combination therapy).
• Clinical Outcomes: Success of trials influencing label expansions.
• Market Penetration: Enhanced adoption driven by evolving treatment protocols.

Projected Sales (USD billion)

Year	Market Size	Growth Rate (%)	Notes
2024	2.1	+4.7	Mild market expansion, ongoing pipeline influence
2025	2.3	+9.5	Favorable trial outcomes, gaining market traction
2026	2.5	+8.7	Regulatory approvals in new indications
2027	2.8	+12.0	Increased uptake in pediatric and combination therapy
2028	3.1	+10.7	Potential biosimilar entries
2029	3.4	+9.7	Market normalization with biosolars
2030	3.7	+8.8	Penetration stabilizes, new lines emerging

Key Opportunities & Risks

Opportunities	Risks
Successful expansion into pediatric and combination therapies	Clinical trial delays or failures
Increasing adoption for resistant CML	Regulatory restrictions or slow approval processes
Potential biosimilar entry increasing accessibility	Pricing pressures from competition

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Comparison with Competing Agents

Parameter	Dasatinib	Imatinib	Bosutinib	Ponatinib
Indications	CML, Ph+ ALL	CML, Ph+ ALL	CML	CML, resistant cases
Market Share (2023)	65%	20%	10%	5%
Approval Date	2006 (FDA)	2001	2012	2013
Key Advantages	Potent in resistant cases	First-generation standard	Fewer side effects	Effective in T315I mutation
Main Limitations	Higher adverse profile	Resistance in some cases	Limited data in large trials	Safety concerns (vascular events)

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Deep-Dive: Policy and Patent Landscape

Aspect	Details
Patent Status (2023)	Patent protections in the US and EMA expire in 2027–2029, enabling biosimilar entry
Pricing Policies	Limited pricing flexibility due to negotiated payers and government agreements
Regulatory Developments	Pending approval for combination regimens in various jurisdictions; potential for label expansion

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Concluding Remarks

While dasatinib remains a cornerstone in CML treatment, its future hinges on successful completion of ongoing clinical trials that explore new indications, combination therapies, and pediatric use. Market growth is expected to remain steady, driven by clinical validation, competitive dynamics, and regional expansion, particularly in Asia-Pacific.

Manufacturers and investors should monitor trial outcomes, regulatory policies, and biosimilar developments closely to adapt strategies effectively.

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Key Takeaways

• Clinical trials bolster dasatinib's position for resistant cases and expanded indications; upcoming data are crucial.
• The market is projected to grow at a CAGR of approx. 4.2%, reaching USD 3.7 billion by 2030.
• Patent expiries by 2027–2029 forecast increased biosimilar competition, likely impacting pricing.
• Competitive advantage remains with demonstrated efficacy and established safety in resistant CML, yet side effect profiles and biosimilar incumbents pose challenges.
• Stakeholders should prioritize pipeline developments and phase III trial outcomes for strategic planning.

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FAQs

1. What are the main clinical advantages of dasatinib over earlier TKIs?
Dasatinib exhibits higher potency against BCR-ABL1 and is effective in cases resistant to imatinib. It also has activity in some TKI-resistant mutations, making it a preferred choice in resistant and advanced CML cases.

2. When are the next major regulatory decisions expected for dasatinib?
Pending results from ongoing trials, potential regulatory updates may occur between 2024 and 2026, especially if new indications are successfully validated.

3. How might biosimilar competition affect dasatinib’s market share?
Biosimilar versions, expected post-2027 patent expiry, could reduce prices and expand access, but may also pressure market dominance for original formulations.

4. Are there emerging combination therapies involving dasatinib?
Yes, clinical trials are testing dasatinib combined with immunotherapies and other targeted agents, aiming to overcome resistance and improve outcomes.

5. What is the outlook for pediatric use of dasatinib?
Recent trials are aiming to extend approval to pediatric patients, filling a significant unmet need and potentially opening new market segments.

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Citations
[1] IQVIA (2023). World Pharmaceutical Market Trends.
[2] Evaluate Pharma (2023). Oncology Market Data.
[3] FDA & EMA approvals.
[4] ClinicalTrials.gov (2023). Dasatinib Trials Data.