AIRSUPRA (albuterol sulfate)
Airsupra is a combination of albuterol (a short-acting beta2-adrenergic agonist) and budesonide (an inhaled corticosteroid). It is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma exacerbations in adults 18 years of age and older. By combining a rapid-acting bronchodilator with an anti-inflammatory steroid in a single inhaler, it addresses both acute symptoms and the underlying inflammation associated with asthma.
How AIRSUPRA Works
Airsupra utilizes two distinct mechanisms of action: 1. **Albuterol:** Acts as a selective beta2-adrenergic agonist. It stimulates adenyl cyclase, increasing intracellular cyclic AMP. This activates protein kinase A, which inhibits myosin phosphorylation and lowers intracellular calcium levels, resulting in the relaxation of airway smooth muscle from the trachea to the terminal bronchioles. 2. **Budesonide:** A potent glucocorticoid that binds to intracellular glucocorticoid receptors. This leads to the modulation of gene transcription, resulting in decreased production of pro-inflammatory cytokines and mediators. This action reduces airway inflammation and hyperreactivity, which is primary in reducing the risk of asthma exacerbations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-01-10
- Patent Cliff
- 2030
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
AIRSUPRA Approval History
What AIRSUPRA Treats
2 indicationsAIRSUPRA is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Bronchoconstriction
AIRSUPRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AIRSUPRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07426458 | 20251152 | Ph 4 | recruiting | Ventilation and Perfusion in Asthmatics |
| NCT06052267 | FpA-AS-30094 2023-505435-12-00 | Ph 3 | recruiting | A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations |
| NCT07166939 MARC-45 | 2025P002364 | Ph 4 | recruiting | 45th Multicenter Airway Research Collaboration |
| NCT05035862 | STUDY00002655 2709 | Ph 1 | terminated | Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma |
| NCT02969408 results posted | ABS-AS-30064 | Ph 3 | completed | A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma |
| NCT03586544 results posted | 1131374-2 | Ph 4 | terminated | Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity |
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
| NCT02566252 | PUL-042-003 | Ph 1 | completed | Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AIRSUPRA FDA Label Details
Indications & Usage
FDA Label (PDF)AIRSUPRA is indicated for the treatment of Asthma; Bronchoconstriction.
AIRSUPRA Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for AIRSUPRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 1 active patents
Trial Analysis
- • 24 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment