PERFOROMIST (formoterol fumarate)
PERFOROMIST is indicated for the treatment of Bronchoconstriction; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema.
How PERFOROMIST Works
Formoterol fumarate is a long-acting, selective beta2-adrenergic receptor agonist. It acts locally in the lung to induce bronchodilation by stimulating intracellular adenyl cyclase, the enzyme responsible for converting adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased levels of cyclic AMP lead to the relaxation of bronchial smooth muscle and inhibit the release of immediate hypersensitivity mediators, such as histamine and leukotrienes, from mast cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-05-11
- Routes
- INHALATION
- Dosage Forms
- SOLUTION
PERFOROMIST Approval History
What PERFOROMIST Treats
4 indicationsPERFOROMIST is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchoconstriction
- Chronic Obstructive Pulmonary Disease
- Chronic Bronchitis
- Emphysema
PERFOROMIST 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 PERFOROMIST
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04320342 TRITON | CLI-05993AA3-06 2020-002389-16 | Ph 3 | completed | A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD |
| NCT03022097 AVANT results posted | D6570C00002 M-AS464-30 | Ph 3 | completed | Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients |
| NCT00929851 | CCD-0906-PR-0016 2009-012546-23 | Ph 3 | completed | BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate) |
| NCT02446418 results posted | 116492 | Ph 3 | completed | A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma |
| NCT01437540 results posted | LAC-MD-32 | Ph 3 | completed | Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease |
| NCT01572792 results posted | LAC-MD-36 | Ph 3 | completed | Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD) |
| NCT01437397 results posted | LAC-MD-31 | Ph 3 | completed | Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
| NCT01462942 results posted | M/40464/30 | Ph 3 | completed | Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination |
| NCT00633776 | Perforomist CT Study | Ph 4 | withdrawn | Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT) |
| NCT01853787 SANOB | 898CEC | Ph 4 | completed | Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients - SANOB Study |
| NCT01113593 | 191-089 | Ph 2 | completed | A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease |
| NCT01168310 | 191-090 | Ph 2 | completed | A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD) |
| NCT00774761 | 191-087 | Ph 2 | completed | A Study Evaluating Systemic Exposure and Pharmacodynamics 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.
PERFOROMIST FDA Label Details
Indications & Usage
FDA Label (PDF)PERFOROMIST is indicated for the treatment of Bronchoconstriction; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema.
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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