Bilastine
As of the edition of 20 October 2026, Bilastine is a small molecule: marketed, first approved in 2010 (ES); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Ibis
- First approved
- 18 November 2010 (ES)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- Aché Laboratórios Farmacêuticos; 6 holders in all
- Registered trials
- 21, 0 stopped early
- Disease areas
- Immune system; Lungs and airways; Ear, nose and throat; Eye; Skin and connective tissue; 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Bilastine.
See the 2 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 1 | 5 | 3 | 0 | 0 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| Phase 4 | 4 | 3 | 0 | 0 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Taiho | Applicant | 2016 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2026 to now |