Betahistine
As of the edition of 20 October 2026, Betahistine is a small molecule: marketed, first approved in 1980 (ES); acts on HRH1 and HRH3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Small molecule
- Brand name
- Serc
- First approved
- 1 July 1980 (ES)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- BGP PHARMA ULC; 3 holders in all
- Registered trials
- 19, 4 stopped early
- Disease areas
- Ear, nose and throat; Nutrition and metabolism; Mental health; Nervous system
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 7 | 2 | 0 | 3 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 19 |