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Levalbuterol HCl Inhalation Solution
Levalbuterol HCl Inhalation Solution 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 UDV, Xopenex Inhalation Solution, R-albuterol.
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).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Levalbuterol HCl Inhalation Solution |
|---|---|
| Also known as | Xopenex UDV, Xopenex Inhalation Solution, R-albuterol |
| 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 rapidly opens constricted airways and improves airflow in patients with obstructive airway diseases. As the pure active enantiomer, levalbuterol may provide enhanced efficacy with potentially fewer side effects compared to racemic albuterol.
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
- Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Evaluation of Dupilumab in Children With Uncontrolled Asthma (PHASE3)
- Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma (PHASE3)
- Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008) (PHASE3)
- Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest) (PHASE3)
- An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma (PHASE2)
- Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma (PHASE2)
- Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED) (PHASE3)
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 HCl Inhalation Solution CI brief — competitive landscape report
- Levalbuterol HCl Inhalation Solution updates RSS · CI watch RSS
- Sumitomo Pharma America, Inc. portfolio CI
Frequently asked questions about Levalbuterol HCl Inhalation Solution
What is Levalbuterol HCl Inhalation Solution?
How does Levalbuterol HCl Inhalation Solution work?
What is Levalbuterol HCl Inhalation Solution used for?
Who makes Levalbuterol HCl Inhalation Solution?
Is Levalbuterol HCl Inhalation Solution also known as anything else?
What drug class is Levalbuterol HCl Inhalation Solution in?
What development phase is Levalbuterol HCl Inhalation Solution in?
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What does Levalbuterol HCl Inhalation Solution target?
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 UDV, Xopenex Inhalation Solution, R-albuterol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing