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Levalbuterol/Levosalbutamol
Levalbuterol is the active R-enantiomer of albuterol that selectively binds to beta-2 adrenergic receptors on airway smooth muscle to cause bronchodilation.
Levalbuterol is the active R-enantiomer of albuterol that selectively binds to beta-2 adrenergic receptors on airway smooth muscle to cause bronchodilation. Used for Acute bronchospasm in patients with reversible obstructive airway disease, Prevention of exercise-induced bronchospasm.
At a glance
| Generic name | Levalbuterol/Levosalbutamol |
|---|---|
| Sponsor | Sanofi |
| Drug class | Beta-2 adrenergic agonist (short-acting) |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Levalbuterol is the pharmacologically active isomer of the racemic mixture albuterol. It binds to beta-2 adrenergic receptors on bronchial smooth muscle, activating adenylyl cyclase and increasing intracellular cAMP, which leads to smooth muscle relaxation and airway dilation. By using only the active R-enantiomer rather than the racemic mixture, levalbuterol may provide improved efficacy and potentially fewer side effects.
Approved indications
- Acute bronchospasm in patients with reversible obstructive airway disease
- Prevention of exercise-induced bronchospasm
Common side effects
- Tremor
- Nervousness
- Headache
- Palpitations
- Tachycardia
- Muscle cramps
Key clinical trials
- A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations (PHASE3)
- High Flow Nasal Cannula Rates in Pediatric Asthma (NA)
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis (PHASE1, PHASE2)
- A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma (PHASE3)
- A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma (PHASE4)
- A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma (PHASE3)
- GRANITE: Airsupra Effectiveness in the Real World
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Levalbuterol/Levosalbutamol CI brief — competitive landscape report
- Levalbuterol/Levosalbutamol updates RSS · CI watch RSS
- Sanofi portfolio CI