TIOTROPIUM BROMIDE
Tiotropium bromide is a long-term, once-daily medication used to manage bronchospasm in patients living with chronic obstructive pulmonary disease (COPD), including those with chronic bronchitis and emphysema. It helps maintain open airways and reduces the frequency of COPD exacerbations. This inhalation powder is designed for daily maintenance to provide consistent respiratory support.
How TIOTROPIUM BROMIDE Works
This medication works by blocking M3-receptors located on the smooth muscle of the airways. By inhibiting these receptors, the drug causes the muscles to relax, which results in bronchodilation. Its effects are site-specific and provide continuous airway opening for more than 24 hours.
Details
- Status
- Prescription
- First Approved
- 2023-06-20
- Routes
- INHALATION
- Dosage Forms
- POWDER
TIOTROPIUM BROMIDE Approval History
What TIOTROPIUM BROMIDE Treats
3 indicationsTIOTROPIUM BROMIDE is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Obstructive Pulmonary Disease
- Chronic Bronchitis
- Emphysema
TIOTROPIUM BROMIDE 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 TIOTROPIUM BROMIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04990167 TioNAAP | 1753113-1 | Ph 2 | terminated | Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP) |
| NCT04061161 ANTIOFLAM | 2018-002173-22 | Ph 4 | completed | Anti-inflammatory Effects of Tiotropium in Patients with Stable COPD |
| NCT03199976 results posted | TFS01 2015-002985-22 | Ph 4 | terminated | Efficacy of Intermittent Tiotropium in Early Childhood Wheezing |
| NCT05113615 | Bio ID 2985 | Ph 4 | completed | Regular Use Tiotropium and Tolerance to Bronchoprotection in Mild Asthma |
| NCT02586649 | SCH-14-019 | Ph 2 | completed | 24hr Effects of Tiotropium Bromide in Tetraplegia |
| NCT01662986 results posted | 205.478 | Ph 4 | completed | Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2 |
| NCT01663987 results posted | 205.477 | Ph 4 | completed | Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1 |
| 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) |
| NCT01316900 results posted | 113360 | Ph 3 | completed | 24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease |
| NCT01566773 results posted | PT001003 | Ph 2 | completed | PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD |
| NCT01316913 results posted | 113374 | Ph 3 | completed | 24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease |
| NCT01751113 SCO116572 results posted | 116572 | Ph 4 | completed | A 3 Way Cross-over Study Evaluating the Effects of ADOAIR Twice Daily Plus Tiotropium Bromide Once Daily Compared With the Individual Treatments of Japanese Subjects |
| NCT00784550 ADC111114 results posted | 111114 | Ph 4 | completed | A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD). |
| NCT00696020 results posted | 1237.4 EudraCT No: 2007-005087-26 | Ph 2 | completed | Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD) |
| NCT01383499 results posted | 205.425 2010-022458-18 | Ph 2 | completed | A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma |
| NCT01437748 | 629CEC | Ph 4 | completed | Closing Volume Interpretation and Bronchodilators Effect |
| NCT01122680 results posted | 205.424 2009-017745-55 | Ph 2 | completed | Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma |
| NCT00563381 results posted | 205.389 EUDRACT2007-001840-33 | Ph 4 | completed | Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients. |
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.
TIOTROPIUM BROMIDE FDA Label Details
Indications & Usage
TIOTROPIUM BROMIDE is indicated for the treatment of Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema.
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SPIRIVA RESPIMAT
Full clinical data, patents, trials, and competitive landscape for tiotropium bromide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.