STIOLTO RESPIMAT (olodaterol hydrochloride)
Stiolto Respimat is a once-daily maintenance medication used for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It combines two different types of medicine to help keep the airways open over the long term. This therapy is not intended for sudden breathing problems or for people with asthma.
How STIOLTO RESPIMAT Works
This drug works by targeting two different pathways to relax the muscles in the airways. Tiotropium blocks M3-receptors to prevent muscle contraction, while olodaterol activates beta 2-receptors to increase cAMP levels, which directly relaxes the smooth muscle cells. Together, these actions produce bronchodilation that lasts for more than 24 hours.
Details
- Status
- Prescription
- First Approved
- 2015-05-21
- Patent Cliff
- 2028
- Routes
- INHALATION
- Dosage Forms
- SPRAY, METERED
Companies
STIOLTO RESPIMAT Approval History
What STIOLTO RESPIMAT Treats
3 indicationsSTIOLTO RESPIMAT is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Obstructive Pulmonary Disease
- Chronic Bronchitis
- Emphysema
STIOLTO RESPIMAT 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.
Drugs Similar to STIOLTO RESPIMAT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03265145 results posted | 1237-0064 | Ph 4 | completed | Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE] |
| NCT02845752 results posted | 1237.55 21394-01 | Ph 4 | completed | The Effect of STIOLTO™ RESPIMAT® on Fatigue in 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.
STIOLTO RESPIMAT FDA Label Details
Indications & Usage
FDA Label (PDF)STIOLTO RESPIMAT is indicated for the treatment of Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema.
STIOLTO RESPIMAT Patents & Exclusivity
Patents (3 active)
Pro Intelligence Preview
Deep insights for STIOLTO RESPIMAT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.