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Xopenex (LEVOSALBUTAMOL)
Xopenex (generic name: LEVOSALBUTAMOL) is a beta2-Adrenergic Agonist Small molecule drug developed by Oak Pharms Inc. It is currently FDA-approved (first approved 1999) for Acute exacerbation of asthma, Bronchospasm, Bronchospasm Prevention.
Xopenex works by activating the beta-2 adrenergic receptor, leading to bronchodilation and relaxation of airway smooth muscle.
Xopenex, also known as levalbuterol, is a small molecule medication used to treat conditions such as asthma, pulmonary disease, and chronic obstructive pulmonary disease (COPD). It is administered via a nebulizer, either electric or human-powered, and is available in various forms, including the ADVAIR DISKUS 250/50mcg inhaler.
At a glance
| Generic name | LEVOSALBUTAMOL |
|---|---|
| Sponsor | Oak Pharms Inc |
| Drug class | beta2-Adrenergic Agonist |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 1999 |
Mechanism of action
Mechanism of Action: Activation of beta2-adrenergic receptors on airway smooth muscle leads to the activation of adenylate cyclase and to an increase in the intracellular concentration of cyclic-3, 5-adenosine monophosphate (cyclic AMP). The increase in cyclic AMP is associated with the activation of protein kinase A, which in turn, inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Levalbuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Increased cyclic AMP concentrations are also associated with the inhibition of the release of mediators from mast cells in the airways. Levalbuterol acts as functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. While it is recognized that beta2-adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there a
Approved indications
- Acute exacerbation of asthma
- Bronchospasm
- Bronchospasm Prevention
Common side effects
- Body as Whole Pain
- Respiratory System Asthma
- Digestive System Vomiting
- Body as Whole Accidental injury
- Respiratory System Pharyngitis
- Respiratory System Rhinitis
- Central Nervous System Dizziness
- Respiratory System Bronchitis
- Angioedema
- Anaphylaxis
- Arrhythmias
- Chest pain
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
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xopenex CI brief — competitive landscape report
- Xopenex updates RSS · CI watch RSS
- Oak Pharms Inc portfolio CI
Frequently asked questions about Xopenex
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Related
- Drug class: All beta2-Adrenergic Agonist drugs
- Target: All drugs targeting Beta-2 adrenergic receptor
- Manufacturer: Oak Pharms Inc — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Acute exacerbation of asthma
- Indication: Drugs for Bronchospasm
- Indication: Drugs for Bronchospasm Prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing