DULERA (formoterol fumarate)
Dulera is a fixed-dose combination of mometasone furoate and formoterol fumarate indicated for the twice-daily treatment of asthma in patients 5 years of age and older. It is intended for patients whose asthma is not adequately controlled on a long-term asthma-control medication, such as an inhaled corticosteroid (ICS), or whose disease severity warrants the initiation of both an ICS and a long-acting beta2-adrenergic agonist (LABA). Dulera is a maintenance therapy and is not indicated for the relief of acute bronchospasm.
How DULERA Works
Dulera combines the anti-inflammatory activity of mometasone furoate with the bronchodilatory effects of formoterol fumarate. Mometasone furoate is a synthetic corticosteroid that inhibits multiple cell types (e.g., mast cells, eosinophils, lymphocytes) and mediators (e.g., histamine, cytokines) involved in the asthmatic inflammatory response. Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist that relaxes bronchial smooth muscle, improving airflow. Together, these components address both the underlying airway inflammation and the physiological bronchoconstriction associated with asthma.
Details
- Status
- Prescription
- First Approved
- 2010-06-22
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
DULERA Approval History
What DULERA Treats
1 indicationsDULERA is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
DULERA 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 DULERA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 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 |
| NCT02045875 results posted | RC-5816 | Ph 4 | completed | Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence |
| 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.
DULERA FDA Label Details
Indications & Usage
FDA Label (PDF)DULERA is indicated for the treatment of Asthma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.