Dolasetron
As of the edition of 20 October 2026, Dolasetron is a small molecule: marketed, first approved in 1997 (US); acts on HTR3A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Anzemet
- First approved
- 11 September 1997 (US)
- Approvals on record
- 5 in 1 region
- Holder of the most recent approval
- Validus Pharmaceuticals
- Registered trials
- 6, 1 stopped early
- Disease areas
- Cancer; Digestive system
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 |
|---|---|---|
| HTR3A | 5-hydroxytryptamine receptor 3A | P46098 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Earlier holder | 1997 to now |
| Validus Pharmaceuticals | Acquired holder | 2021 to now |