Benzydamine
As of the edition of 20 October 2026, Benzydamine is a small molecule: marketed, first approved in 1968 (ES); acts on PTGS1 and PTGS2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1993
- Kind
- Small molecule
- Brand name
- Tantum
- First approved
- 1 June 1968 (ES)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Bausch Health; 2 holders in all
- Registered trials
- 10, 0 stopped early
- Disease areas
- Mouth and teeth; Ear, nose and throat; Infections; Lungs and airways
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 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Benzydamine.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 3 | 2 | 1 | 0 |
| Phase 2 | 1 | 0 | 0 | 0 |
| Phase 3 | 2 | 0 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1993 to now |