TheraRadar
Data updated: May 26, 2026

GLEEVEC (imatinib mesylate)

Oncology Approved 2001-05-10
Jump to: Indications Approvals Trials Competitors Safety Patents
19
Indications
--
Phase 3 Trials
9
Priority Reviews
25
Years on Market

Details

Status
Discontinued
First Approved
2001-05-10
Revenue
$128M (Q4-2023)

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

Novartis
Active Ingredient: IMATINIB MESYLATE

GLEEVEC Approval History

2002
2003
2004
2005
2006
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
104 FDA actions from 2001 to 2026 · 14 indication expansions
Jan 2026 SUPPL
Label · Labeling
FDA Letter Label
Mar 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Aug 2022 SUPPL
Label · Labeling
FDA Letter Label

What GLEEVEC Treats

19 FDA approvals

Originally approved for its first indication in 2001 . Covers 19 distinct patient populations.

  • Other (19)
📋

Clinical Trial Registry

52 trials
Trial Sponsor ID Phase Status Title
NCT03007147 AALL1631 NCI-2016-01588, AALL1631 Ph 3 active not recruiting Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT01742299 CSTI571A2406 2012-002540-25 Ph 4 completed Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator
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
NCT04129931 results posted 19-1681 5U24HL138998-03 Ph 2 completed PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
NCT04488081 I-SPY_COVID I-SPY-COVID Ph 2 active not recruiting I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
NCT06655246 KO-MEN-015 Ph 1 recruiting A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
NCT03997903 IMPACT results posted IMPACT SCA Ph 1, Ph 2 terminated Imatinib for Pain in Sickle Cell Anemia
NCT05623774 IkT-001Pro-501 Ph 1 completed A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg
NCT05385549 AMC2202 Ph 2 recruiting 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk
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
NCT01738139 2012-0784 NCI-2018-01811, 2012-0784 Ph 1 completed Ipilimumab and Imatinib Mesylate in Advanced Cancer
NCT05970900 PIRKER 2023XHYG0025-01 Ph 3 not yet recruiting Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST
NCT00764595 GISTs CDR0000615628 NIIGATAU-TRIGIST0805 Ph 2 completed Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
NCT01005914 results posted IRB00004913 OHSU-4913, ENZON-OHSU-4913 Ph 2 terminated Pegaspargase and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT02712112 AMC1601 Ph 2 completed A Study of Intermittent Dosing Schedule of Imatinib in Patients With Tyrosine Kinase Inhibitor Refractory GISTs
NCT04953052 IMPRESS COVID EX003 959310 Ph 2 withdrawn A Randomized Study to Investigate the Effect of Intravenous Imatinib on the Amount of Oxygen in the Lungs and Blood of Adults With COVID-19 Needing Mechanical Ventilation and Supportive Care.
NCT03023046 results posted 9770 NCI-2016-02050, 9770 Ph 2 completed Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT02644525 results posted 999916042 16-I-N042 Ph 2 terminated Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa
NCT00769327 CML0408 CML0408 GIMEMA-CML0408, EUDRACT-2008-004384-19 Ph 2 completed Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
NCT03688568 1505569560 1R01FD004830-01A2 Ph 2 withdrawn Study of Imatinib in Children With Neurofibromatosis and Airway Tumors
NCT02303899 ONC-2014-002 Ph 2 completed Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Pleural Mesothelioma
NCT01827930 MIM results posted IB2009-07 2008-007094-20 Ph 3 terminated Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
NCT02257541 results posted 14-140 Ph 1, Ph 2 completed BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
NCT00509093 results posted CASE4906 P30CA043703, CASE4906 Ph 2 completed Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy
NCT01781975 results posted 17-2013-6 Ph 2 completed Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus
NCT01578213 ISAV ISAV 2011-002749-37 Ph 4 completed Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
NCT02177825 PLNEU SJ 01 Ph 2 terminated Study of Imatinib Mesylate in Neurofibromatosis Type I Patients Aged 2 to 21 With Plexiform Neurofibromas
NCT02538926 9459 NCI-2015-01402, CC9459 Ph 2 withdrawn Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride With Asparaginase in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT02709083 results posted IRB00087045 NCI-2016-00162, Winship3143-16 Ph 2 terminated Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
NCT02812693 OSU-15280 NCI-2016-00864, P30CA016058 Ph 1, Ph 2 withdrawn Pembrolizumab and Imatinib in Patients With Locally Advanced/Metastatic Melanoma With c-KIT Mutation/Amplification
NCT00867113 results posted CSTI571BUS282 Ph 2 completed Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
NCT01312818 results posted 2008LS113 MT2008-33R, 1010M91973 Ph 2 terminated Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
NCT00882206 results posted 2008LS112 0810M50401, MT2008-29R Ph 2 terminated Pre-reinductive Decitabine and Vorinostat in Relapsed Lymphoblastic Lymphoma or Acute Lymphoblastic Leukemia
NCT00324987 S0502 results posted NCI-2009-00776 NCI-2009-00776, CDR0000482236 Ph 3 terminated Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
NCT00702403 results posted 2223.00 NCI-2010-00402, P30CA015704 Ph 1, Ph 2 completed Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML
NCT01383447 results posted NCI-2010-02202 J1023, U01CA070095 Ph 1, Ph 2 terminated Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT01140360 0908-09 results posted NF/Gleevec DOD Trial 0908-09 Ph 1, Ph 2 completed Pilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform Neurofibromas
NCT01172548 INV555 CSTI571BIC08 Ph 2 completed Safety and Efficacy Evaluation of Two Year Imatinib Treatment in Adjuvant Gastrointestinal Stromal Tumor (GIST)
NCT01097694 KIA results posted 2010P000170 U01HL102225 Ph 2 completed Effects of cKit Inhibition by Imatinib in Patients With Severe Refractory Asthma (KIA)
NCT00684411 results posted 08-063 Ph 2 completed Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
NCT01483014 CONVERT CSTI571BBR10 Ph 2 completed Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
NCT01297777 EudraCT 2010-019189-94 Ph 4 completed Imatinib in KIT-negative Systemic Mastocytosis
NCT01309997 results posted 2343.00 NCI-2011-00098, RDCRN 6502 Ph 2 completed Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease
NCT00902174 IMPRES results posted CQTI571A2301 Ph 3 completed Imatinib (QTI571) in Pulmonary Arterial Hypertension
NCT01011075 6137p results posted INST CST1571BUS240 NCI-2011-02947, 6137p Ph 2 completed Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
NCT01267695 WJP-320.6700.09010 Ph 2 completed Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
NCT01281865 results posted NCI-2011-02577 NCI-2011-02577, CDR0000693826 Ph 1, Ph 2 completed Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma
NCT00686218 07203 P30CA033572, NOVARTIS-CSTI571AUS275T Ph 1 completed Panobinostat (LBH589) and Imatinib Mesylate in Treating Patients With Previously Treated Chronic Phase Chronic Myelogenous Leukemia
NCT00732784 08-072 CSTI571BUS 280, UPCI 08-072 Ph 1 completed Effect of Calcium on Gleevec Pharmacokinetics (PK) in Healthy Volunteers
NCT01031628 results posted SARC019 STI571BUS286T Ph 3 terminated Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients

Showing 50 of 52 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

GLEEVEC FDA Label Details

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Revenue Insights

  • • Q4-2023: $128M
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

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Data Sources

FDA Approval: NDA021335 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.