IMKELDI (imatinib mesylate)
Imkeldi is a targeted therapy used to manage several types of blood-related cancers and specific solid tumors in both adults and children. It helps patients with Philadelphia chromosome positive leukemias, including chronic myeloid leukemia and acute lymphoblastic leukemia, at various stages of the disease. This medication also treats rare conditions such as aggressive systemic mastocytosis, hypereosinophilic syndrome, and gastrointestinal stromal tumors.
How IMKELDI Works
Imkeldi works by blocking specific proteins called tyrosine kinases, including the abnormal BCR-ABL protein found in certain leukemias. By inhibiting these signals, the drug prevents cancer cells from multiplying and triggers them to undergo cell death. It also targets other receptors like c-Kit and PDGFR, which helps control the growth of tumors in the digestive system and skin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-11-22
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- SOLUTION
IMKELDI Approval History
What IMKELDI Treats
7 indicationsIMKELDI is approved for 7 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Myelodysplastic/Myeloproliferative Diseases
- Systemic Mastocytosis
- Hypereosinophilic Syndrome
- Chronic Eosinophilic Leukemia
- Dermatofibrosarcoma Protuberans
IMKELDI Target & Pathway
ProTarget
An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.
IMKELDI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IMKELDI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IMKELDI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IMKELDI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
51 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 |
| 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 |
| NCT00956072 | EORTC-62063 EORTC-62063, EU-20955 | Ph 3 | terminated | Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate |
Showing 50 of 51 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
IMKELDI FDA Label Details
Indications & Usage
FDA Label (PDF)IMKELDI is indicated for the treatment of Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic/Myeloproliferative Diseases; Systemic Mastocytosis; Hypereosinophilic Syndrome; Chronic Eosinophilic Leukemia; Dermatofibrosarcoma Protuberans.
IMKELDI Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for IMKELDI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 1 active patents
Trial Analysis
- • 55 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment