Arsenic trioxide
As of the edition of 20 October 2026, Arsenic trioxide is a small molecule: marketed, first approved in 1988 (CH); acts on TXNRD1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Small molecule
- Brand name
- Trisenox
- First approved
- 6 January 1988 (CH)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Teva; 3 holders in all
- Withdrawn from market
- 14 April 2025 (in some regions)
- Registered trials
- 129, 34 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Urinary and reproductive; Digestive system
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.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Arsenic trioxide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TXNRD1 | Thioredoxin reductase 1, cytoplasmic | Q16881 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 0 | 1 | 1 |
| Phase 1 | 30 | 14 | 3 | 8 |
| Phase 2 | 79 | 38 | 9 | 24 |
| Phase 3 | 11 | 5 | 2 | 1 |
| Phase 4 | 3 | 1 | 0 | 0 |
| All trials | 129 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Teva | Applicant and Acquired holder | 2002 to now |