PROVENTIL-HFA (albuterol sulfate)
Proventil-HFA helps patients aged four and older manage or prevent the sudden narrowing of airways associated with reversible obstructive lung disease. It is also used to prevent breathing difficulties triggered by physical activity in both adults and children. This medication provides relief by relaxing the muscles throughout the respiratory tract, from the trachea down to the smallest bronchioles.
How PROVENTIL-HFA Works
This medication works by stimulating beta 2-adrenergic receptors found in the smooth muscles of the airways. This activation triggers a chemical process that increases cyclic AMP and lowers calcium levels within the cells, leading to muscle relaxation and the opening of the respiratory passages. It also helps prevent the release of certain inflammatory substances from mast cells in the airway.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-08-15
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
PROVENTIL-HFA Approval History
What PROVENTIL-HFA Treats
3 indicationsPROVENTIL-HFA is approved for 3 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Obstructive Airway Disease
- Exercise-Induced Bronchospasm
PROVENTIL-HFA 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 PROVENTIL-HFA
3 of 10FDA-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 |
| 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) |
| NCT01189396 | API-A006-CL-C | Ph 2 | completed | Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006 |
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.
PROVENTIL-HFA FDA Label Details
Indications & Usage
FDA Label (PDF)PROVENTIL-HFA is indicated for the treatment of Bronchospasm; Obstructive Airway Disease; Exercise-Induced Bronchospasm.
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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