Imatinib
As of the edition of 20 October 2026, Imatinib is a small molecule: marketed, first approved in 2001 (US); acts on ABL1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Small molecule
- Brand name
- Gleevec
- First approved
- 10 May 2001 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Shorla Oncology; 3 holders in all
- Withdrawn from market
- 31 August 2023 (in some regions)
- Registered trials
- 457, 79 stopped early
- Disease areas
- Cancer; Blood and lymph; Digestive system; Immune system; Lungs and airways; Skin and connective tissue
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ABL1 | Tyrosine-protein kinase ABL1 | P00519 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 31 | 17 | 5 | 1 |
| Phase 1 | 70 | 52 | 5 | 12 |
| Phase 2 | 288 | 173 | 25 | 55 |
| Phase 3 | 50 | 28 | 7 | 10 |
| Phase 4 | 18 | 10 | 2 | 1 |
| All trials | 457 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2000 to now |
| Shorla Oncology | Later holder | 2024 to now |