Trabectedin
As of the edition of 20 October 2026, Trabectedin is a small molecule: marketed, first approved in 2007 (EU).
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
- Yondelis
- First approved
- 17 September 2007 (EU)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Apotex; 5 holders in all
- Registered trials
- 82, 9 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Hormones; Digestive system; Skin and connective tissue
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 | 8 | 5 | 0 | 0 |
| Phase 1 | 12 | 7 | 1 | 3 |
| Phase 2 | 49 | 34 | 8 | 4 |
| Phase 3 | 12 | 10 | 1 | 1 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 82 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2002 to now |
| Taiho | Applicant | 2015 to now |
| Adium | Applicant | 2024 to now |
| Apotex | Later holder | 2026 to now |