Thalidomide
As of the edition of 20 October 2026, Thalidomide is a small molecule: marketed, first approved in 1998 (US); acts on CRBN; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Thalomid
- First approved
- 16 July 1998 (US)
- Approvals on record
- 13 in 4 regions
- Holder of the most recent approval
- Lipomed; 4 holders in all
- Withdrawn from market
- 1 January 1963 (in some regions)
- Registered trials
- 341, 45 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Digestive system; Urinary and reproductive
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 |
|---|---|---|
| CRBN | Protein cereblon | Q96SW2 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 20 | 9 | 5 | 2 |
| Phase 1 | 16 | 10 | 0 | 3 |
| Phase 2 | 225 | 137 | 17 | 30 |
| Phase 3 | 64 | 40 | 4 | 8 |
| Phase 4 | 16 | 5 | 1 | 2 |
| All trials | 341 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator, Applicant and Lead sponsor of trials | 1998 to now |
| Lipomed | Applicant | 2022 to now |