ALBUTEROL SULFATE; IPRATROPIUM BROMIDE (albuterol sulfate)
Albuterol sulfate helps patients manage and prevent bronchospasms associated with reversible obstructive airway disease. It is used for both adults and children four years of age and older to improve breathing by relaxing the muscles in the airways. Healthcare providers also use it to prevent breathing difficulties that can occur during or after physical activity.
How ALBUTEROL SULFATE; IPRATROPIUM BROMIDE Works
This medication works by targeting and activating beta 2-adrenergic receptors located on the smooth muscle of the airways. This process triggers an increase in cyclic AMP, which leads to muscle relaxation and the widening of the air passages from the trachea to the bronchioles. It also helps by preventing the release of certain inflammatory mediators from mast cells in the lungs.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-12-31
- Routes
- INHALATION
- Dosage Forms
- SOLUTION
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE Approval History
What ALBUTEROL SULFATE; IPRATROPIUM BROMIDE Treats
2 indicationsALBUTEROL SULFATE; IPRATROPIUM BROMIDE is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Obstructive Airway Disease
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 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.
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Clinical Trial Registry
7 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 |
| 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.
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE FDA Label Details
Indications & Usage
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE is indicated for the treatment of Bronchospasm; Obstructive Airway Disease.
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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