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.

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

Last updated: July 27, 2026

Dasatinib clinical trials update, market analysis, and exclusivity-linked launch projections (2026–2035)

Dasatinib (Sprycel; Bristol Myers Squibb) is an established, off-patent small-molecule TKI for chronic myeloid leukemia (CML) and Ph+ ALL. In 2026, the market remains driven by legacy CML treatment algorithms, ongoing trials in earlier lines and combinations, and periodic guideline updates that influence patient selection. Near-term demand growth is modest because dasatinib is widely genericized in the US and key markets, shifting competitive dynamics to price, formulary access, and tolerability. The key IP question is no longer primary composition, but residual patent barriers around specific dosing, formulations, and new combinations in defined patient subsets.

Bottom line: clinical trial activity is concentrated in (1) sequencing and combination regimens for CML-CP and CML-AP and (2) attempts to deepen molecular response while managing safety. Commercial projections depend on country-specific generic penetration, payer switching speed, and whether new clinical evidence supports continued use over alternative TKIs (e.g., imatinib, nilotinib, bosutinib, ponatinib).

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What is dasatinib, and what clinical trial areas are active in 2024–2026?

Dasatinib is a BCR-ABL1 inhibitor used across CML and Ph+ ALL settings. Trial focus in recent years has shifted from first approvals to fine-tuning: earlier treatment depth of response, MRD strategies, and management of resistance.

Featured clinical intent buckets

• Deeper molecular response in CML (MR4/MR4.5 milestones), including treatment optimization and time-to-response endpoints.
• Sequencing strategies versus other TKIs for efficacy and tolerability.
• Combination regimens intended to improve durability and reduce resistance.
• Safety mitigation studies (pleural effusion, cytopenias), including supportive care and dose modifications.
• Special populations: older adults, comorbidities, and patients previously exposed to other TKIs.
• Ph+ ALL trials exploring dasatinib-based regimens in defined age/risk groups.

Trial read-through for business

• Trials that land on label expansion or materially improve response rates for a distinct line of therapy tend to extend payer uptake and delay disfavor versus competitors.
• Trials that refine safety or monitoring without changing efficacy endpoints primarily affect switching behavior within formularies, not overall category demand.

Which phase mix dominates dasatinib trial updates?

• Late-phase studies and protocol-driven observational or translational extensions remain common because the drug’s core efficacy is well established.
• Randomized trials persist where a new combination or sequencing question is genuinely differentiating.

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Which current dasatinib trials are most likely to change market behavior?

Market-changing trials are those that:

1. shift dasatinib earlier in the treatment algorithm,
2. improve rates of major molecular response (MMR) and/or deep molecular response,
3. produce clear progression-free survival (PFS) or treatment-free remission (TFR)-relevant results, or
4. reduce discontinuations or serious adverse events, including pleural effusion and cytopenias.

High-probability impact patterns

• Trials that establish dasatinib as a default choice in first-line or second-line settings in specific patient strata (e.g., tolerability profiles, resistance mutations).
• Studies that support MRD-guided dosing or discontinuation strategies, because those outcomes affect long-term treatment duration and total spend.

Low-probability impact patterns

• Pure pharmacokinetic or minor dose/formulation studies without meaningful efficacy changes.
• Trials that confirm expected efficacy but do not create payer-relevant superiority versus standard comparators.

How to monitor trial signals that matter

• Primary endpoints: MMR within fixed time windows, MR4/MR4.5 frequency, TFR rates, and molecular relapse kinetics.
• Safety endpoints: grade 3/4 pleural effusion rates, management strategies, and discontinuation due to adverse events.
• Subgroup results: patients with prior TKI exposure, specific BCR-ABL1 mutation patterns, and older or comorbid populations.

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How large is the dasatinib market, and what drives demand in 2026?

Demand drivers

• Persistent CML incidence and long treatment duration, even with generic substitution.
• Treatment algorithms that keep dasatinib as a viable option where tolerability or resistance patterns favor it.
• Ongoing use in Ph+ ALL regimens (lower overall patients than CML but meaningful in institutional protocols).
• Formulary decisions that determine which generics or branded products win uptake.

Supply-side drivers

• Generic competition in the US and abroad compresses prices and shifts growth from value to volume.
• Ongoing manufacturing capacity and supply stability affect payer and provider switching.

What category dynamics matter most versus other TKIs?

• Nilotinib and bosutinib compete strongly in CML because of differences in safety profiles and molecular kinetics.
• Ponatinib competes in resistant disease but with different risk management.
• Imatinib remains a baseline for select lines, reducing total category opportunity but expanding the addressable population.

Business implication: even if dasatinib is not “preferred” by guidelines for every subgroup, it maintains a durable baseline because switching is constrained by patient history, mutation spectrum, and prior tolerability.

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What are the market risks to dasatinib (2026–2035)?

Risks

• Continued guideline migration to alternative TKIs with better discontinuation and long-term safety profiles in specific lines.
• Faster than expected erosion of effective pricing due to additional generic entrants and aggressive payer contracting.
• Lower switching to dasatinib if clinical evidence increasingly favors other TKIs for MRD depth or fewer discontinuations.
• Supply chain constraints or quality events that affect access.

How trials translate into risk

• If trials show another TKI combination improves TFR or reduces serious AEs, dasatinib adoption slows even when the drug remains effective.
• If dasatinib trial results demonstrate superior molecular durability or manageable pleural effusion outcomes with optimized monitoring, it can defend share within generic categories.

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What is the patent and exclusivity status of dasatinib in the US (Orange Book practical view)?

Dasatinib’s primary branded lifecycle protections are historically long expired or near expiration in major jurisdictions. In 2026, commercial differentiation is mainly shaped by:

• any remaining method-of-use or combination regimen patents,
• formulation or dosing patents (if any still in force),
• and the extent to which generics have cleared regulatory and litigation barriers.

Featured business question

• Are any Orange Book-listed patents still active that can delay generic entry for specific dosage forms, strengths, or labeled indications?

Where does IP still matter for a generic-dominated market?

• For litigation leverage: remaining method-of-use patents can support carve-outs in settlements.
• For regulatory strategy: additional exclusivity (if any remains for certain changes) can delay specific submissions.
• For commercial strategy: branded firms may still defend use in particular indications if claims remain enforceable.

Key litigation leverage points to track

• Paragraph IV challenges: whether filers were challenged and what settlement dates govern ongoing design-around.
• Injunction or consent judgment scopes tied to specific strengths or label sections.

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When does dasatinib lose exclusivity, and what does that mean for launch timing?

Practical answer in 2026: dasatinib exclusivity in the conventional sense does not anchor a near-term branded-to-generic “cliff” the way it would for a newly approved drug. Instead, launch timing is driven by:

• whether additional patents remain to block specific generic variants,
• how quickly payers switch once generic entry is complete,
• and whether any label-protecting patents delay carve-outs.

Launch projection logic (what determines generic share after entry)

• Time to formulary adoption: 1 to 6 quarters depending on payer contracting cycles.
• Switching friction: patient stability on current TKI, physician preference, and prior adverse event history.
• Discounting: larger impact when multiple generics compete aggressively in the same NDC/strength.

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Which generic entry risks exist for dasatinib in key jurisdictions?

Because dasatinib is mature, the dominant entry risks are not “first generic” but:

• additional ANDA supply reaching sufficient volume,
• ability to launch at scale without price erosion below manufacturer economics,
• and any remaining patent barriers specific to certain indications or regimen claims.

What to monitor for a new entry wave

• A pattern of multiple ANDAs clearing around the same time often signals multi-filer readiness.
• Court outcomes affecting the scope of design-arounds in method-of-use or combination patents.
• Settlement agreements that delay specific strengths or label sections.

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How does dasatinib compare with nilotinib, bosutinib, and ponatinib in market share and patient selection?

Competitive positioning

• Nilotinib often competes on molecular kinetics and certain tolerability aspects, while maintaining a different adverse event profile.
• Bosutinib can be selected based on clinician preference and side effect management.
• Ponatinib is reserved more for resistant or mutation-defined cases due to risk considerations.

Commercial effect

• Dasatinib’s market share is resilient in generic markets because physicians continue to use it where history, mutation response, and tolerability have established fit.
• Competitive pressure is strongest in lines where another TKI shows a better benefit-risk profile in head-to-head evidence or where guidelines shift.

Business “watch items”

• MRD/TFR-related comparative signals that tilt decisions toward one TKI.
• Discontinuation rates: fewer discontinuations can increase durable volume even under price pressure.
• Real-world adverse event management outcomes.

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What dosing, formulations, and method-of-use patents could still matter?

In mature TKIs, residual patent matters most in:

• specific dosing schedules that optimize tolerability or response,
• formulations that change exposure or improve patient adherence,
• and method-of-use claims tied to defined subgroups or endpoint strategies.

Formulation patent focus to search

• Changes in tablet composition, excipients, or dissolution characteristics.
• Strength-specific manufacturing improvements that could create non-infringing pathways for some generics but not others.

Method-of-use focus

• Treatment lines (first-line vs second-line vs resistant disease).
• Defined combinations with other agents.
• Protocols for MRD-guided discontinuation, where claim language can be narrow but commercially significant.

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How strong is the dasatinib patent estate for combination regimens?

Combination regimen patents can have disproportionate business impact if they:

• preserve branded indications in practice through settlement carve-outs,
• or support exclusivity-like effects by limiting generic labeling expansion.

Key strength indicators

• Whether claims are broad enough to cover standard-of-care combinations used in clinical practice.
• Whether litigation has produced narrow interpretations that weaken enforceability.
• Whether patents remain in force in target jurisdictions where payer formularies are negotiated.

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What patent litigation affects dasatinib (and what settlements drive generic design-around)?

For an established TKI, the most valuable litigation intelligence is:

• the identity of Paragraph IV filers,
• the jurisdictions where cases were litigated,
• whether settlements include consent judgments restricting launch timing,
• and whether those restrictions are limited to certain strengths, labels, or generic design choices.

How to translate litigation outcomes into projections

• If settlements impose early launch limits, near-term value retention increases for any branded remaining supply.
• If litigation produced broad invalidation or non-infringement rulings, generic competition accelerates and prices compress faster.

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What is the FDA regulatory status of dasatinib and what does it mean for future approvals?

Dasatinib is FDA-approved for CML and Ph+ ALL indications established historically. New clinical evidence could influence:

• label expansions (less common in mature markets),
• safety labeling updates (e.g., pleural effusion monitoring guidance),
• or regimen refinements through supplemental approvals.

Regulatory signals that change revenue

• Label expansions that define new eligible populations or treatment settings.
• Safety label tightening that reduces use or changes dosing behavior.
• Formal MRD/TFR-related labeling changes, if supported by robust trial evidence.

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Dasatinib revenue exposure and projection scenarios (2026–2035)

Projection framework for an off-patent TKI

• Volume growth tracks incidence and persistence, not brand-only uptake.
• Value growth depends on price erosion pace after each generic entry wave.
• Switching dynamics determine whether dasatinib keeps share versus competing TKIs.

Scenario bands

• Base case (most likely): stable volume with ongoing price compression; modest net revenue growth or decline depending on geography and payer mix.
• Bull case: evidence in trials supports dasatinib in earlier lines or improves TFR/discontinuation strategies, defending share against competing TKIs; pricing stabilizes via fewer entrants or stronger contracting.
• Bear case: additional competitive erosion plus guideline drift to alternatives; dasatinib share declines in key patient segments.

Geographic drivers

• US: fastest pricing erosion due to dense generic competition; revenue depends on residual branded supply only if any and on contracting.
• EU: pricing and reimbursement policies influence how quickly generics erode.
• Emerging markets: lower price points but higher absolute volume potential; regulatory approvals and local contracting control the ramp.

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Key Takeaways

• Dasatinib clinical activity in 2024–2026 centers on optimization: molecular response depth, sequencing, MRD/TFR-adjacent strategies, and safety mitigation rather than core re-proving of efficacy.
• The 2026–2035 commercial outlook is dominated by generic price erosion, payer formulary dynamics, and competition versus nilotinib, bosutinib, and ponatinib.
• IP is unlikely to create a single major exclusivity expiration cliff. Remaining leverage, if any, is in residual method-of-use, dosing, formulation, or combination regimen patents and in litigation/settlement scopes that affect label carve-outs and generic launch timing.
• Market-changing trials are those that alter earlier-line adoption, improve TFR-relevant durability, or reduce discontinuations in a payer-relevant way.

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FAQs

1) What endpoints in dasatinib CML trials most affect market adoption?
MMR and deep molecular response rates at fixed timepoints, PFS, treatment-free remission metrics, and serious adverse event and discontinuation rates.

2) Do dasatinib combination trials risk generic entry via label expansion?
Yes when clinical regimens become standard practice and any enforceable method-of-use claims expire or are narrowed, enabling labeling approaches that reduce differentiation.

3) How do pleural effusion data influence clinician switching between dasatinib and other TKIs?
Clinicians weigh both incidence and management practicality; evidence showing lower discontinuations or improved monitoring compliance can defend share.

4) What drives formulary switching for dasatinib after generic entry?
Contracting terms, number of equivalent suppliers, NDC/strength availability, and patient stability on existing therapy.

5) What is the most important signal to watch for future dasatinib label changes?
Randomized evidence that shifts sequencing earlier or improves durability with MRD/TFR-relevant outcomes that support supplemental label additions.

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. ClinicalTrials.gov. Search results for “dasatinib” trial listings. U.S. National Library of Medicine.
3. Bristol Myers Squibb. SPRYCEL (dasatinib) Prescribing Information and Safety/Clinical Studies sections. FDA label.