NDAORALTABLETPriority Review
Approved
Jun 2006
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
105
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPRYCEL (dasatinib) is an oral small-molecule tyrosine kinase inhibitor approved in 2006 for treating Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. It works by inhibiting BCR-ABL kinase and multiple SRC family kinases at nanomolar concentrations, enabling it to overcome imatinib resistance from kinase domain mutations and alternate signaling pathways. SPRYCEL is positioned as a second-line or alternative first-line therapy for Ph+ CML, particularly in cases of imatinib intolerance or resistance.
$0.5BPart D
5mo to LOEMechanism 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 (105)
Dasatinib for HIV-1 Reservoir Reduction
Started Apr 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.