Palonosetron
As of the edition of 20 October 2026, Palonosetron is a small molecule: marketed, first approved in 2003 (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 2010
- Kind
- Small molecule
- Brand name
- Aloxi
- First approved
- 25 July 2003 (US)
- Approvals on record
- 15 in 3 regions
- Holder of the most recent approval
- Taiho; 6 holders in all
- Registered trials
- 101, 6 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Blood and lymph; Digestive system; Immune system; Lungs and airways
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.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Palonosetron.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HTR3A | 5-hydroxytryptamine receptor 3A | P46098 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 17 | 13 | 2 | 0 |
| Phase 1 | 4 | 2 | 2 | 0 |
| Phase 2 | 33 | 19 | 4 | 6 |
| Phase 3 | 27 | 20 | 1 | 0 |
| Phase 4 | 20 | 16 | 4 | 0 |
| All trials | 101 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Helsinn Healthcare | Originator and Lead sponsor of trials | 2003 to now |
| Helsinn Birex Pharmaceuticals | Applicant | 2005 to now |
| Taiho | Applicant and Lead sponsor of trials | 2006 to now |
| Dr. Reddy's | Later holder | 2016 to now |
| Exela Pharma Sciences | Later holder | 2016 to now |
| Fresenius Kabi | Later holder | 2017 to now |
| Hikma Pharmaceuticals | Acquired holder | 2019 to now |
| Avyxa | Acquired holder | 2024 to now |