Desloratadine
As of the edition of 20 October 2026, Desloratadine is a small molecule: marketed, first approved in 2001 (EU); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Clarinex
- First approved
- 15 January 2001 (EU)
- Approvals on record
- 22 in 7 regions
- Holder of the most recent approval
- Kern Pharma; 9 holders in all
- Withdrawn from market
- 10 March 2004 (in some regions)
- Registered trials
- 60, 2 stopped early
- Disease areas
- Immune system; Lungs and airways; Ear, nose and throat; Skin and connective tissue; Infections; Inherited and neonatal
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 Desloratadine.
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 | 0 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 6 | 1 | 4 | 0 |
| Phase 3 | 20 | 16 | 1 | 1 |
| Phase 4 | 19 | 16 | 0 | 1 |
| All trials | 60 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Applicant, Acquired holder and Lead sponsor of trials | 2001 to now |
| Bayer | Applicant | 2001 to now |
| Merck & Co. | Applicant | 2001 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2014 to now |
| Eurofarma Laboratorios | Later holder and Lead sponsor of trials | 2020 to now |