Data updated: May 26, 2026
SPRYCEL (dasatinib)
Genetically Validated
Trial Activity: Stable 48 active trials
Oncology
Approved 2006-06-28
Sprycel is a medication used for adults and children with specific types of blood cancers, specifically Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia. It helps patients who are newly diagnosed as well as those who have not responded well to or cannot tolerate previous therapies like imatinib. Doctors prescribe it to manage various stages of leukemia, ranging from the stable chronic phase to more aggressive accelerated or blast phases.
Source: FDA Label • Bristol-Myers Squibb
How SPRYCEL Works
This drug works by inhibiting several specific proteins called kinases, including BCR-ABL and the SRC family, which drive the growth of cancer cells. By binding to multiple forms of the ABL kinase, it stops the proliferation of leukemia cells, including those that have developed resistance to other treatments. This action helps overcome resistance caused by genetic mutations or the activation of alternative signaling pathways within the cells.
Development Insights
National Cancer Institute (NCI) conducting 22 trials (13%)
434 indications explored (Broad Platform)
→ acute lymphoblastic leukemia (16 trials)
→ chronic myeloid leukemia (8 trials)
→ acute myeloid leukemia (6 trials)
8
Indications
--
Phase 3 Trials
4
Priority Reviews
19
Years on Market
Details
- Status
- Prescription
- First Approved
- 2006-06-28
- Patent Cliff
- 2026
- Revenue
- $80M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
SPRYCEL Approval History
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
141 FDA actions from 2006 to 2024 · 7 indication expansions
Jan 2015 SUPPL Priority
Mfg
What SPRYCEL Treats
2 indicationsSPRYCEL is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
- Acute Lymphoblastic Leukemia
Source: FDA Label
SPRYCEL Target & Pathway
ProTarget
An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.
SPRYCEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
5
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
7
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 16 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SPRYCEL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SPRYCEL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SPRYCEL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
DASATINIB
DASATINIB
BIOCON PHARMA
Shared indications:
Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
IMKELDI
IMATINIB MESYLATE
SHORLA ONCOLOGY
Shared indications:
Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
PHYRAGO
DASATINIB
HANDA THERAP
Shared indications:
Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
📋
Clinical Trial Registry
172 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT04530565 | NCI-2020-06381 NCI-2020-06381, EA9181 | Ph 3 | active not recruiting | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT06124157 | NCI-2023-09214 NCI-2023-09214, AALL2131 | Ph 2 | recruiting | A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT04877522 | CABL001A2001B 2021-000602-17, 2023-507557-16-00 | Ph 4 | recruiting | Asciminib Roll-over Study |
| NCT04872790 | STUDY00022691 NCI-2021-01791, STUDY00022691 | Ph 1 | active not recruiting | Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia |
| NCT07000734 FOES | 202503023 | Ph 2 | completed | Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study |
| NCT07269470 | 2025-1526 NCI-2025-08780 | Ph 2 | not yet recruiting | Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT06390319 | SJALL23T NCI-2024-03015 | Ph 2 | recruiting | Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL) |
| NCT06533748 | SJALL23H NCI-2024-06013 | Ph 2 | recruiting | Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma |
| NCT01445509 | 090019 09-C-0019 | Ph 1 | completed | Dasatinib in Combination With Bevacizumab to Treat Advanced Solid Tumors |
| NCT02559778 PEDS-PLAN | NMTRC012 | Ph 2 | recruiting | Pediatric Precision Laboratory Advanced Neuroblastoma Therapy |
| NCT04925648 PICASSO | PICASSO | Ph 2 | completed | Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction |
| NCT05838560 | 202302203 | Ph 2 | active not recruiting | Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders |
| NCT02143414 results posted | NCI-2014-01047 NCI-2014-01047, SWOG-S1318 | Ph 2 | active not recruiting | Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia |
| NCT01660971 | NCI-2012-01290 NCI-2012-01290, VICCGI1173 | Ph 1 | active not recruiting | Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery |
| NCT00792948 results posted | NCI-2009-00800 NCI-2009-00800, S0805 | Ph 2 | active not recruiting | Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT04329325 | 19-343 | Ph 2 | active not recruiting | Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
| NCT04971226 results posted | CABL001J12301 2023-508838-33-00 | Ph 3 | active not recruiting | A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP |
| NCT03516279 | EA9171 NCI-2017-02161, EA9171 | Ph 2 | active not recruiting | Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease |
| NCT07342491 | A5413 | Ph 1 | not yet recruiting | Dasatinib for HIV-1 Reservoir Reduction |
| NCT04747912 | IRB20-1749 | Ph 2 | suspended | Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO) |
| NCT03297606 CAPTUR | PM1 ESR-17-12831, CA209-9DL | Ph 2 | recruiting | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) |
| NCT06645886 | KQB198-102 | Ph 1 | active not recruiting | A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies |
| NCT07493408 ASIM-POST Ph+ | ASCPT-01 | Ph 2 | not yet recruiting | Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML |
| NCT07144293 IPACE-HIV | A5426 | Ph 2 | active not recruiting | Improving Physical Ability and Cellular Senescence Elimination in HIV |
| NCT06055621 VEN-R DASA | VEN-R DASA-IPC 2022-067 | Ph 2 | recruiting | Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE |
| NCT02389309 | 2014-0692 NCI-2015-00524, 2014-0692 | Ph 1 | active not recruiting | Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors |
| NCT02689440 | 2015-1040 NCI-2016-00362, 2015-1040 | Ph 2 | active not recruiting | Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia |
| NCT05007873 | 2021-0271 NCI-2021-08486, 2021-0271 | Ph 2 | recruiting | ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase |
| NCT02523976 | IIT2015001 | Ph 2 | completed | Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia |
| NCT06940297 | MC240801 NCI-2025-02490, 24-002915 | Ph 2 | recruiting | Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma |
| NCT03020030 | 16-001 | Ph 3 | active not recruiting | Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents |
| NCT04785300 | 19-003394 | Ph 1, Ph 2 | active not recruiting | ALSENLITE: Senolytics for Alzheimer's Disease |
| NCT03654768 results posted | S1712 NCI-2017-02066, S1712 | Ph 2 | active not recruiting | Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia |
| NCT03117751 | TOT17 NCI-2017-00582 | Ph 2, Ph 3 | active not recruiting | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma |
| NCT03595917 | 18-170 | Ph 1 | recruiting | ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML |
| NCT05198843 results posted | NCI-2022-00004 NCI-2022-00004, 10480 | Ph 1, Ph 2 | terminated | Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body |
| NCT05993949 | IRB-68603 NCI-2023-05591 | Ph 1 | active not recruiting | Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia |
| NCT05192889 results posted | RAVEN NCI-2022-00304 | Ph 1, Ph 2 | active not recruiting | Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax |
| NCT05751044 HEM-iSMART B | 2022-501866-22-00 | Ph 1, Ph 2 | recruiting | HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies |
| NCT00777036 results posted | CA180-226 2008-002260-33 | Ph 2 | completed | A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib |
| NCT06855810 CCCG-TALL-2025 | IIT2025014 | Ph 2, Ph 3 | recruiting | Newly-diagnosed Pediatric T-cell ALL Protocol |
| NCT01990196 | 13-000714 NCI-2015-01448 | Ph 2 | active not recruiting | Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer |
| NCT04838041 | PRO00040685 | Ph 2 | recruiting | Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation |
| NCT02494882 | 14-272 | Ph 1 | active not recruiting | 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 |
| NCT02420717 results posted | 2014-0521 NCI-2015-00779, 2014-0521 | Ph 2 | terminated | Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia |
| NCT01751425 | 2012-0697 NCI-2018-01797, 2012-0697 | Ph 1 | terminated | Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors |
| NCT05527418 DASAHIVCURE | 2021-001288-26 | Ph 2 | recruiting | Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection |
| NCT03560908 | IIT2018004 | Ph 1 | withdrawn | Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation |
Showing 50 of 172 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SPRYCEL FDA Label Details
Indications & Usage
FDA Label (PDF)SPRYCEL is indicated for the treatment of Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia.
View full patent landscape →
2 OB patents · 1 families ·
7 international docs across 1 countries
SPRYCEL Patents & Exclusivity
Latest Patent: Sep 2026
Exclusivity: Jun 2026
Patents (2 active)
US7491725*PED
Expires Sep 28, 2026
US7491725
Expires Mar 28, 2026
Exclusivity
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
ODE-225
Until Dec 2025
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
PED
Until Jun 2026
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for SPRYCEL
Revenue Insights
- • Q4-2025: $80M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 72 active patents
Trial Analysis
- • 174 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment