Rupatadine
As of the edition of 20 October 2026, Rupatadine is a small molecule: marketed, first approved in 2001 (ES); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Rupafin
- First approved
- 4 July 2001 (ES)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Teikoku Seiyaku; 4 holders in all
- Registered trials
- 11, 4 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Ear, nose and throat; Lungs and airways; Heart and blood vessels; 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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Rupatadine.
See the 1 company 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 | 1 | 0 | 1 | 0 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 1 | 0 | 0 | 1 |
| Phase 4 | 3 | 0 | 0 | 2 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Medexus Pharma | Applicant | 2016 to now |
| Teikoku Seiyaku | Applicant | 2017 to now |