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IMATINIB
IMATINIB is a drug. It is currently FDA-approved (first approved 2001) for Newly Diagnosed Ph+ CML, Ph+ CML in BC, AP, CP, Relapsed/Refractory Ph+ ALL.
Imatinib is a small molecule used to treat conditions such as Gastrointestinal Stromal Tumors (GIST) and other types of cancer. It is a medication that has been studied in clinical trials, including a comparison to nilotinib in a Phase III study for GIST patients.
At a glance
| Generic name | IMATINIB |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2001 |
Approved indications
- Newly Diagnosed Ph+ CML
- Ph+ CML in BC, AP, CP
- Relapsed/Refractory Ph+ ALL
- Newly Diagnosed Ph+ ALL in Pediatrics
- MDS/MPD with PDGFR Rearrangements
- Aggressive Systemic Mastocytosis
- HES/CEL with FIP1L1-PDGFRα Fusion
- Unresectable/Recurrent/Metastatic DFSP
- Kit+ Unresectable/Metastatic GIST
- Adjuvant Treatment of Kit+ GIST
Common side effects
- Fluid retention
- Superficial edema
- Nausea
- Muscle cramps
- Musculoskeletal pain
- Diarrhea
- Rash and related terms
- Fatigue
- Headache
- Abdominal pain
- Nasopharyngitis
- Hemorrhage
Serious adverse events
- Pleural effusion
- Pulmonary edema
- Ascites
- Pericardial effusion
- Severe superficial edema
- Abdominal pain (Grade 3/4)
- Musculoskeletal pain (Grade 3/4)
- Rash (Grade 3/4)
- Diarrhea (Grade 3/4)
- Hemorrhage (Grade 3/4)
Key clinical trials
- A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (PHASE3)
- Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML (PHASE2)
- Trial of Imatinib for Hospitalized Adults With COVID-19 (PHASE3)
- Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor (PHASE1)
- Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IMATINIB CI brief — competitive landscape report
- IMATINIB updates RSS · CI watch RSS
Frequently asked questions about IMATINIB
What is IMATINIB?
What is IMATINIB used for?
When was IMATINIB approved?
What development phase is IMATINIB in?
What are the side effects of IMATINIB?
Related
- Indication: Drugs for Newly Diagnosed Ph+ CML
- Indication: Drugs for Ph+ CML in BC, AP, CP
- Indication: Drugs for Relapsed/Refractory Ph+ ALL
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing