Granisetron
As of the edition of 20 October 2026, Granisetron is a small molecule: marketed, first approved in 1991 (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
- Kytril
- First approved
- 12 April 1991 (FR)
- Approvals on record
- 16 in 6 regions
- Holder of the most recent approval
- Taiyo Pharma Co Ltd; 10 holders in all
- Registered trials
- 72, 7 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Blood and lymph; Pregnancy and women's health; Digestive system; Hormones
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Granisetron.
See the 2 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 | 11 | 8 | 0 | 1 |
| Phase 1 | 14 | 11 | 0 | 3 |
| Phase 2 | 16 | 10 | 0 | 3 |
| Phase 3 | 21 | 15 | 1 | 0 |
| Phase 4 | 10 | 6 | 2 | 0 |
| All trials | 72 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Earlier holder | 1993 to now |
| Roche | Applicant, Acquired holder, Later holder and Lead sponsor of trials | 1998 to now |
| Heron Therapeutics | Later holder and Lead sponsor of trials | 2006 to now |
| Grünenthal | Applicant | 2012 to now |
| Apotex | Acquired holder | 2026 to now |