NDAORALTABLETPriority Review
Approved
Apr 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLEEVEC (imatinib mesylate) is an oral small-molecule tyrosine kinase inhibitor approved in 2003 for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It represents a paradigm shift in oncology by targeting the BCR-ABL fusion protein, transforming CML from a fatal disease into a manageable chronic condition.
$0.073BPart D
LOE ApproachingProduct approaching loss of exclusivity with moderate competitive pressure (30), indicating a contracting team and shift toward lifecycle management and generic defense strategies.
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 (20)
Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST
Started Oct 2023
23 enrolled
Gastrointestinal Stromal Tumor of Rectum
A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg
Started Dec 2022
64 enrolled
CML
Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma
Started Sep 2020
22 enrolled
Melanoma
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
Started May 2012
37 enrolled
Chronic Myeloid LeukemiaGastrointestinal Stromal Tumor
Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
Started Oct 2010
3 enrolled
Chronic Myeloid Leukemia (CML)Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
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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.