Thiotepa
As of the edition of 20 October 2026, Thiotepa is a small molecule: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Thioplex
- First approved
- 1 January 1982 (US)
- Approvals on record
- 13 in 4 regions
- Holder of the most recent approval
- Adienne; 8 holders in all
- Registered trials
- 223, 34 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Nervous system; Skin and connective tissue; Inherited and neonatal
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 5 | 5 | 1 |
| Phase 1 | 35 | 18 | 9 | 6 |
| Phase 2 | 143 | 63 | 35 | 26 |
| Phase 3 | 29 | 15 | 9 | 1 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 223 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Acquired holder | 2003 to now |
| Adienne | Later holder | 2017 to now |
| Shorla Pharma | Later holder | 2024 to now |
| Pfizer | Earlier holder |