NDAORALTABLETPriority Review
Approved
Jun 2006
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
21
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPRYCEL (dasatinib) is an oral small-molecule tyrosine kinase inhibitor approved in 2006 for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). It works by inhibiting BCR-ABL and other kinases, blocking cancer cell proliferation. The drug is administered orally as tablets and has become a standard-of-care option in hematologic malignancies.
$510MPart D
LOE Approaching0mo to LOEProduct approaching loss of exclusivity with $510M in Part D spending; defensive strategies and lifecycle management initiatives will drive brand team priorities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Dasatinib for HIV-1 Reservoir Reduction
Started May 2026
14 enrolled
HIV Infections
ASCiminib, With or Without Dasatinib Combination, as a 2nd-Line Therapy to ADVANCE the Treatment for Chronic Myelogenous Leukemia in Chronic Phase (ASC2ADVANCE)
Started Apr 2026
45 enrolled
Chronic Myeloid Leukemia (CML) in
Bioequivalence Studies of Dasatinib 100 Mg
Started Sep 2025
46 enrolled
Myeloma Multiple
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)
Started Dec 2024
100 enrolled
T-cell Acute Lymphoblastic LeukemiaT-cell LymphomaMixed Phenotype Acute Leukemia
Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia
Started Oct 2023
8 enrolled
Lymphoblastic Leukemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.