SEREVENT (salmeterol xinafoate)
Serevent helps patients aged 4 and older manage long-term asthma symptoms and is used for the maintenance of breathing difficulties associated with chronic obstructive pulmonary disease (COPD). For asthma, it must be used in combination with an inhaled corticosteroid, specifically for patients whose symptoms are not adequately controlled by steroids alone. This medication also helps prevent exercise-induced bronchospasm in both adults and children. It is important to note that this drug is not intended to provide quick relief for sudden, acute breathing episodes.
How SEREVENT Works
This medication works by stimulating the enzyme adenyl cyclase, which increases levels of cyclic AMP within the airways. This process leads to the relaxation of bronchial smooth muscles and prevents mast cells from releasing inflammatory chemicals like histamine and leukotrienes. By targeting these specific receptors, the drug helps keep the airways open and reduces bronchial hyper-responsiveness over an extended period.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1994-02-04
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED, POWDER
SEREVENT Approval History
What SEREVENT Treats
4 indicationsSEREVENT is approved for 4 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Exercise-Induced Bronchospasm
- Chronic Obstructive Pulmonary Disease
- Bronchospasm
SEREVENT Boxed Warning
ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmet...
WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Use of background ICS was not required in this study. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Use of SEREVENT DISKUS for the treatment of asthma as monotherapy without a concomitant ICS is contraindicated. Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS. Pediatric and Adolescent Patients Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of an ICS and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA is recommended. WARNING: ASTHMA-RELATED DEATH See full prescribing information for complete boxed warning. • Long-act
SEREVENT 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.
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
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06282861 ANTES B+ | ANTES B+ 2023-507304-32 | Ph 4 | terminated | ANTES B+ Clinical Trial |
| NCT04195867 SALM | IMIMFTCL/SALM | Ph 1 | completed | Generation of Biological Samples Positive to Salmeterol for Anti-Doping Control |
| NCT00565266 TALC results posted | 547 U10HL074206, U10HL074208 | Ph 3 | completed | Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC) |
| NCT01712451 LIPO-102-CL-11 | LIPO-102-CL-11 | Ph 2 | completed | Dose-ranging Study |
| NCT00975195 results posted | 352.2046 2007-002522-29 | Ph 4 | completed | Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease |
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.
SEREVENT FDA Label Details
Indications & Usage
FDA Label (PDF)SEREVENT is indicated for the treatment of Asthma; Exercise-Induced Bronchospasm; Chronic Obstructive Pulmonary Disease; Bronchospasm.
WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared ...
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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