Ketotifen
As of the edition of 20 October 2026, Ketotifen is a small molecule: marketed, first approved in 1981 (FR); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Zaditor
- First approved
- 6 April 1981 (FR)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 7 holders in all
- Registered trials
- 23, 1 stopped early
- Disease areas
- Immune system; Eye; Lungs and airways; Skin and connective tissue; Bones, joints and muscles; Cancer
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
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 Ketotifen.
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 |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 6 | 2 | 2 | 1 |
| Phase 3 | 9 | 9 | 0 | 0 |
| Phase 4 | 5 | 3 | 0 | 0 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1997 to now |
| Bausch Health | Later holder and Lead sponsor of trials | 2006 to now |
| Alcon | Acquired holder and Lead sponsor of trials | 2011 to now |
| Thea Pharma | Applicant | 2011 to now |
| Johnson & Johnson | Later holder | 2022 to now |