Ondansetron
As of the edition of 20 October 2026, Ondansetron is a small molecule: marketed, first approved in 1990 (FR); acts on HTR3A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Zofran
- First approved
- 5 March 1990 (FR)
- Approvals on record
- 24 in 6 regions
- Holder of the most recent approval
- DR. REDDYS FARMACĂUTICA DO BRASIL LTDA; 12 holders in all
- Registered trials
- 259, 27 stopped early
- Disease areas
- Cancer; Mental health; Digestive system; Chemically induced; Heart and blood vessels; Nervous 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HTR3A | 5-hydroxytryptamine receptor 3A | P46098 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 59 | 39 | 7 | 4 |
| Phase 1 | 45 | 40 | 1 | 4 |
| Phase 2 | 51 | 37 | 3 | 9 |
| Phase 3 | 51 | 36 | 4 | 6 |
| Phase 4 | 53 | 34 | 9 | 4 |
| All trials | 259 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Earlier holder | 1991 to now |
| Endo | Later holder and Lead sponsor of trials | 2002 to now |
| Sandoz | Acquired holder and Lead sponsor of trials | 2004 to now |
| Baxter Healthcare | Later holder | 2006 to now |
| Aquestive Therapeutics | Acquired holder and Lead sponsor of trials | 2008 to now |
| Takeda | Applicant and Lead sponsor of trials | 2012 to now |