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Levalbuterol tartrate HFA MDI
Levalbuterol tartrate HFA MDI is a Beta-2 adrenergic receptor agonist (short-acting bronchodilator) Small molecule drug developed by Sumitomo Pharma America, Inc.. It is currently in Phase 3 development for Acute bronchospasm in patients with reversible obstructive airway disease, Maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). Also known as: Xopenex MDI, Xopenex HFA MDI.
Levalbuterol is a selective beta-2 adrenergic receptor agonist that relaxes airway smooth muscle to improve breathing.
Levalbuterol is a selective beta-2 adrenergic receptor agonist that relaxes airway smooth muscle to improve breathing. Used for Acute bronchospasm in patients with reversible obstructive airway disease, Maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Levalbuterol tartrate HFA MDI |
|---|---|
| Also known as | Xopenex MDI, Xopenex HFA MDI |
| Sponsor | Sumitomo Pharma America, Inc. |
| Drug class | Beta-2 adrenergic receptor agonist (short-acting bronchodilator) |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Levalbuterol is the active R-enantiomer of albuterol that binds to beta-2 adrenergic receptors on airway smooth muscle cells, triggering increased intracellular cAMP and causing bronchodilation. This relieves airway obstruction and improves airflow in patients with obstructive airway diseases. The HFA (hydrofluoroalkane) formulation is a metered-dose inhaler delivery system.
Approved indications
- Acute bronchospasm in patients with reversible obstructive airway disease
- Maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Nervousness
- Headache
- Palpitations
- Tachycardia
- Muscle cramps
Key clinical trials
- A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects (PHASE3)
- A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma (PHASE3)
- Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects (PHASE3)
- Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD (PHASE3)
- Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects (PHASE2)
- Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma (PHASE2)
- Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma (PHASE2)
- A Safety and Tolerability Study of Levalbuterol HFA Metered Dose Inhaler in Subjects With Asthma (PHASE2)
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 tartrate HFA MDI CI brief — competitive landscape report
- Levalbuterol tartrate HFA MDI updates RSS · CI watch RSS
- Sumitomo Pharma America, Inc. portfolio CI
Frequently asked questions about Levalbuterol tartrate HFA MDI
What is Levalbuterol tartrate HFA MDI?
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Related
- Drug class: All Beta-2 adrenergic receptor agonist (short-acting bronchodilator) drugs
- Target: All drugs targeting Beta-2 adrenergic receptor
- Manufacturer: Sumitomo Pharma America, Inc. — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Acute bronchospasm in patients with reversible obstructive airway disease
- Indication: Drugs for Maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD)
- Also known as: Xopenex MDI, Xopenex HFA MDI
- Compare: Levalbuterol tartrate HFA MDI vs similar drugs
- Pricing: Levalbuterol tartrate HFA MDI cost, discount & access