Temozolomide
As of the edition of 20 October 2026, Temozolomide is a small molecule: marketed, first approved in 1999 (EU).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Temodar
- First approved
- 26 January 1999 (EU)
- Approvals on record
- 19 in 6 regions
- Holder of the most recent approval
- Merck & Co.; 2 holders in all
- Withdrawn from market
- 15 September 2022 (in some regions)
- Registered trials
- 864, 134 stopped early
- Disease areas
- Cancer; Nervous system; Skin and connective tissue; Digestive system; Lungs and airways; Hormones
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 29 | 10 | 8 | 6 |
| Phase 1 | 207 | 112 | 44 | 39 |
| Phase 2 | 550 | 249 | 147 | 80 |
| Phase 3 | 74 | 23 | 26 | 9 |
| Phase 4 | 4 | 3 | 1 | 0 |
| All trials | 864 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1999 to now |
| Nippon Kayaku | Applicant |