Data updated: Mar 10, 2026
GLEEVEC
IMATINIB MESYLATE
Approved 2001-05-10
19
Indications
--
Phase 3 Trials
9
Priority Reviews
24
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2001-05-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
GLEEVEC Approval History
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What GLEEVEC Treats
19 FDA approvalsOriginally approved for its first indication in 2001 . Covers 19 distinct patient populations.
- Other (19)
Other
(19 approvals)- • Approved indication (May 2001) PriorityLabel Letter
- • Approved indication (Feb 2002) PriorityLabel Letter
- • Approved indication (Dec 2002) PriorityLabel Letter
- • Approved indication (Apr 2003) PriorityLabel Letter
- • Approved indication (May 2003) PriorityLabel Letter
- • Approved indication (Dec 2003)Label Letter
- • Approved indication (Mar 2005)Label Letter
- • Approved indication (Oct 2005)Label Letter
- • Approved indication (Sep 2006) PriorityLabel Letter
- • Approved indication (Oct 2006)Label Letter
- • Approved indication (Sep 2007)Label Letter
- • Approved indication (Sep 2008)Label Letter
- • Approved indication (Dec 2008) PriorityLetter
- • Approved indication (May 2009)Letter
- • Approved indication (Apr 2011)Label Letter
- • Approved indication (Jan 2012) PriorityLabel Letter
- • Approved indication (Jan 2013) PriorityLabel Letter
- • Approved indication (Jan 2015)Label Letter
- • Approved indication (Aug 2016)Label Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.