Fexofenadine
As of the edition of 20 October 2026, Fexofenadine is a small molecule: marketed, first approved in 1996 (US); acts on HRH1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Allegra
- First approved
- 25 July 1996 (US)
- Approvals on record
- 22 in 5 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Registered trials
- 67, 4 stopped early
- Disease areas
- Immune system; Lungs and airways; Ear, nose and throat; Skin and connective tissue; Inherited and neonatal; Heart and blood vessels
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 23 | 20 | 1 | 2 |
| Phase 2 | 8 | 5 | 2 | 1 |
| Phase 3 | 9 | 6 | 3 | 0 |
| Phase 4 | 23 | 21 | 0 | 1 |
| All trials | 67 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 1996 to now |