Cetirizine
As of the edition of 20 October 2026, Cetirizine is a small molecule: marketed, first approved in 1989 (ES); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Zyrtec
- First approved
- 1 November 1989 (ES)
- Approvals on record
- 24 in 5 regions
- Holder of the most recent approval
- Kenvue Brands; 9 holders in all
- Registered trials
- 68, 6 stopped early
- Disease areas
- Immune system; Lungs and airways; Ear, nose and throat; Skin and connective tissue; Nervous system; Infections
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 Cetirizine.
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 | 9 | 7 | 1 | 0 |
| Phase 1 | 17 | 16 | 0 | 1 |
| Phase 2 | 10 | 7 | 1 | 1 |
| Phase 3 | 18 | 14 | 2 | 2 |
| Phase 4 | 14 | 11 | 0 | 2 |
| All trials | 68 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1996 to now |
| Johnson & Johnson | Acquired holder, Later holder and Lead sponsor of trials | 2001 to now |
| UCB | Applicant and Lead sponsor of trials | 2002 to now |
| JDP Therapeutics | Later holder and Lead sponsor of trials | 2013 to now |
| Bionpharma | Acquired holder | 2016 to now |
| Nicox Ophthalmics | Later holder and Lead sponsor of trials | 2016 to now |
| Harrow Eye | Acquired holder | 2023 to now |
| Kenvue Brands | Acquired holder | 2025 to now |
| Esteve Pharmaceuticals | Acquired holder | 2026 to now |