Levosalbutamol
As of the edition of 20 October 2026, Levosalbutamol is a small molecule: marketed, first approved in 1999 (US); acts on ADRB2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Small molecule
- Brand name
- Xopenex
- First approved
- 25 March 1999 (US)
- Approvals on record
- 5 in 1 region
- Holder of the most recent approval
- Lupin; 2 holders in all
- Registered trials
- 22, 2 stopped early
- Disease areas
- Lungs and airways; Immune system; Infections; Nutrition and metabolism; Skin and connective tissue
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 |
|---|---|---|
| ADRB2 | Beta-2 adrenergic receptor | P07550 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 8 | 7 | 0 | 1 |
| Phase 4 | 6 | 4 | 0 | 1 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lupin | Acquired holder | 2023 to now |
| Hikma Pharmaceuticals | Acquired holder | 2023 to now |