Salmeterol
As of the edition of 20 October 2026, Salmeterol is a small molecule: marketed, first approved in 1991 (FR); acts on ADRB2.
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
- Serevent
- First approved
- 30 December 1991 (FR)
- Approvals on record
- 29 in 7 regions
- Holder of the most recent approval
- Teva; 5 holders in all
- Withdrawn from market
- 23 May 2025 (in some regions)
- Registered trials
- 154, 12 stopped early
- Disease areas
- Lungs and airways; Immune system; Infections; Nutrition and metabolism; Blood and lymph; Bones, joints and muscles
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 Salmeterol.
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 |
|---|---|---|
| ADRB2 | Beta-2 adrenergic receptor | P07550 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 27 | 20 | 4 | 2 |
| Phase 1 | 14 | 14 | 0 | 0 |
| Phase 2 | 24 | 21 | 2 | 0 |
| Phase 3 | 40 | 29 | 1 | 5 |
| Phase 4 | 49 | 39 | 0 | 5 |
| All trials | 154 |