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Drug

Imatinib Mesylate

Approved · FDA
ClassStem cell growth factor receptor inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Gleevec, Imatinib mesilate, imatinib (as mesylate).

RxNorm284924ChEMBLCHEMBL1642UNII8A1O1M485B
15
Research papers
6
Active clinical trials
4
Protein targets
55
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: IMATINIB MESYLATE (NDA021588)

Regulatory2026-07-13FDA

Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

Clinical trial2026-06-18Results expected Q3 2028 · ClinicalTrials.gov

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Clinical trial2026-05-04Results expected Q3 2027 · ClinicalTrials.gov

An Open Label, Multi-center Imatinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Imatinib Study and Are Judged by the Investigator to Benefit From Continued Imatinib Treatment

Clinical trial2026-04-20Completed · ClinicalTrials.gov

PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

Clinical trial2026-04-01Results posted · ClinicalTrials.gov

Label change: IMATINIB MESYLATE (NDA021588)

Regulatory2026-01-14FDA

Label change: IMATINIB (ANDA204644)

Regulatory2024-12-09FDA

Supplemental approval: IMATINIB MESYLATE (NDA021588)

Regulatory2024-03-01FDA

KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST.

Research2024-02-27Cell communication and signaling : CCS

Genomic profiling in GIST: Implications in clinical outcome and future challenges.

Research2024-01-05Neoplasia (New York, N.Y.)

Imatinib therapy for patients with recent-onset type 1 diabetes: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.

Research2021-06-29The lancet. Diabetes & endocrinology

European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia.

Research2020-03-03Leukemia

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Imatinib Mesylate
Aliases & brands
GleevecImatinib mesilateimatinib (as mesylate)
RxNorm CUI
284924
ChEMBL ID
CHEMBL1642
UNII
8A1O1M485B
Primary mechanism
Stem cell growth factor receptor inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Mast/stem cell growth factor receptor Kit
KIT · P10721
INHIBITORStem cell growth factor receptor inhibitor
Tyrosine-protein kinase ABL1
ABL1 · P00519
INHIBITORTyrosine-protein kinase ABL inhibitor
Platelet-derived growth factor receptor beta
PDGFRB · P09619
INHIBITORPlatelet-derived growth factor receptor beta inhibitor
Breakpoint cluster region protein
BCR · P11274
INHIBITORBcr/Abl fusion protein inhibitor

Regulatory timeline

55 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2003-04-18
Latest approval
2024-03-01
Authorities
FDA
Total events
55
fdaU.S. Food and Drug Administration· 55 events
2026-07-13Label change
Label change: IMATINIB MESYLATE (NDA021588)
Evidence ↗
2026-01-14Label change
Label change: IMATINIB MESYLATE (NDA021588)
Evidence ↗
2024-12-09Label change
Label change: IMATINIB (ANDA204644)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

197 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
197
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
2
Recruiting
30
Late-stage (III+)
142
Completed
49
Discontinued
PHASE DISTRIBUTIONn = 197
Early Phase 11Phase 128Phase 1 / 223Phase 2114Phase 2 / 32Phase 320Phase 46Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open Label, Multi-center Imatinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Imatinib Study and Are Judged by the Investigator to Benefit From Continued Imatinib Treatment

CompletedPH IVNovartis Pharmaceuticalsn=1552026

Imatinib Mesylate Therapy in Systemic Mastocytosis Patients Lacking KIT Mutations

CompletedPH IVHospital Virgen de la Saludn=102015

Multicenter, Single-arm, Two Stage Phase II Trial of RAD001 (Everolimus) With Imatinib in Imatinib-resistant Patients With Progressive GIST

CompletedPH IVNovartis Pharmaceuticalsn=282012

Glivec in Pediatric Chronic Myeloid Leukemia (CML)

CompletedPH IVPoitiers University Hospitaln=442011

Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

CompletedPH IVNovartis Pharmaceuticalsn=642009

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open Label, Multi-center Imatinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Imatinib Study and Are Judged by the Investigator to Benefit From Continued Imatinib Treatment

CompletedPH IVNovartis Pharmaceuticalsn=1552026

PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

CompletedPH IIUniversity of North Carolina, Chapel Hilln=9502025

A Randomized Trial for Adults with Newly Diagnosed Acute Lymphoblastic Leukemia

CompletedUniversity College, London2025

A Dose Calibration and Dose Equivalence Pharmacokinetic Study in Healthy Volunteers Comparing IkT-001Pro to Imatinib Mesylate 400mg

CompletedPH IInhibikase Therapeuticsn=642024

A Phase I Trial of Ipilimumab (Immunotherapy) and Imatinib Mesylate (c-Kit Inhibitor) in Patients With Advanced Malignancies

CompletedPH IM.D. Anderson Cancer Centern=682023

Entacapone in Combination With Imatinib Mesylate for Treatment of Patients With Gastrointestinal Stromal Tumors(GIST) Following Failure of at Least Imatinib and Sunitinib

CompletedPH IXiangya Hospital of Central South Universityn=52022

Research activity

15 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022024
Most influential

Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors.

The New England journal of medicine · 2002 · 2,941 cites

Somatic activation of KIT in distinct subtypes of melanoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2006 · 1,088 cites

European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia.

Leukemia · 2020 · 1,035 cites

Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2007 · 1,031 cites

Tyrosine kinases as targets for cancer therapy.

The New England journal of medicine · 2005 · 917 cites

Gastrointestinal stromal tumors: the incidence, prevalence, clinical course, and prognostication in the preimatinib mesylate era--a population-based study in western Sweden.

Cancer · 2005 · 839 cites
Recent papers

KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST.

Cell communication and signaling : CCS · 2024 · 28 cites

Genomic profiling in GIST: Implications in clinical outcome and future challenges.

Neoplasia (New York, N.Y.) · 2024 · 20 cites

Imatinib therapy for patients with recent-onset type 1 diabetes: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.

The lancet. Diabetes & endocrinology · 2021 · 112 cites

European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia.

Leukemia · 2020 · 1,035 cites

A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2016 · 63 cites

Imatinib mesylate lacks efficacy in relapsed/refractory peripheral T cell lymphoma.

Leukemia & lymphoma · 2015 · 2 cites
Major research themes6
Gastrointestinal Stromal Tumors2Antineoplastic Agents1Biological Products1Fluorodeoxyglucose F181Genotype1Positron-Emission Tomography1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • The New England journal of medicine2
  • Annals of surgical oncology1
  • Arthritis and rheumatism1
  • Cancer1
  • Cell communication and signaling : CCS1
Leading researchers
  • Blanke CD3
  • Demetri GD3
  • Heinrich MC3
  • von Mehren M3
  • Eisenberg B2
  • Eisenberg BL2
  • Hoffman JP2
  • Kane JM2
Leading institutions
free-text, unnormalised
  • Dana-Farber Cancer Institute2
  • University of Chicago2
  • Almazov National Research Centre1
  • Amsterdam University Medical Center1
  • Barbara Davis Center1
  • Benaroya Research Institute1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Sunitinib

Acts on the same molecular target as Imatinib Mesylate, with 3 overlapping disease areas.

2 shared targets3 shared diseases1 shared paper
Dasatinib

Acts on the same molecular target as Imatinib Mesylate, with an overlapping disease area.

2 shared targets1 shared disease1 shared paper
Bosutinib

Acts on the same molecular target as Imatinib Mesylate, with an overlapping disease area.

Shared target1 shared disease1 shared paper
Nilotinib

Studied across the same disease area as Imatinib Mesylate in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.