Overview
Tiotropium is a long-acting, antimuscarinic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD) and asthma. Tiotropium acts mainly on M3 muscarinic receptors located in the airways to produce smooth muscle relaxation and bronchodilation. Tiotropium is more specific for the subset of muscarinic receptors commonly found in the lungs than ipratropium. Tiotropium was granted FDA approval on 30 January 2004.
Background
Tiotropium is a long-acting, antimuscarinic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD) and asthma. Tiotropium acts mainly on M3 muscarinic receptors located in the airways to produce smooth muscle relaxation and bronchodilation. Tiotropium is more specific for the subset of muscarinic receptors commonly found in the lungs than ipratropium. Tiotropium was granted FDA approval on 30 January 2004.
Indication
Tiotropium powder for inhalation is indicated for the maintenance of bronchospasm in COPD and to prevent exacerbations of COPD. A combination tiotropium and olodaterol metered inhalation spray is indicated for maintenance of COPD. A tiotropium inhalation spray is indicated for the maintenance of bronchospasm in COPD, to prevent exacerbations of COPD, and to treat asthma in patients 12 or more years old. A tiotropium metered inhalation spray is indicated for the maintenance of bronchospasm in COPD, to prevent exacerbations of COPD, and to treat asthma in patients 6 or more years old.
Associated Conditions
- Asthma
- Bronchitis
- Bronchoconstriction
- Chronic Bronchitis
- Chronic Obstructive Pulmonary Disease (COPD)
- Emphysema
- Exacerbation of COPD
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/07 | Phase 4 | Not yet recruiting | |||
2024/07/29 | N/A | Completed | |||
2024/07/05 | Phase 1 | Active, not recruiting | |||
2024/03/22 | Phase 1 | Active, not recruiting | |||
2024/02/28 | Phase 4 | Recruiting | |||
2024/02/12 | Phase 1 | Completed | |||
2023/05/01 | Phase 2 | Withdrawn | |||
2022/08/18 | Phase 4 | Completed | |||
2022/08/15 | N/A | Completed | |||
2022/06/02 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0155 | RESPIRATORY (INHALATION) | 3.124 ug in 1 1 | 5/23/2023 | |
Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0155 | RESPIRATORY (INHALATION) | 3.124 ug in 1 1 | 5/23/2023 | |
Lupin Pharmaceuticals, Inc. | 68180-964 | ORAL, RESPIRATORY (INHALATION) | 18 ug in 1 1 | 12/14/2023 | |
Physicians Total Care, Inc. | 54868-5109 | ORAL, RESPIRATORY (INHALATION) | 18 ug in 1 1 | 7/6/2010 | |
A-S Medication Solutions | 50090-4248 | ORAL, RESPIRATORY (INHALATION) | 18 ug in 1 1 | 11/30/2021 | |
A-S Medication Solutions | 50090-4414 | ORAL, RESPIRATORY (INHALATION) | 18 ug in 1 1 | 10/1/2019 | |
Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0075 | ORAL, RESPIRATORY (INHALATION) | 18 ug in 1 1 | 11/30/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM | SIN15890P | SOLUTION | 0.0025 mg/actuation | 2/25/2020 | |
TIOSPIREX 13 mcg inhalation powder, hard capsule | SIN15858P | CAPSULE | 0.013mg | 11/19/2019 | |
SPIRIVA® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM | SIN15885P | SOLUTION | 0.0025 mg/actuation | 2/18/2020 | |
Zenhale Pressurized Inhalation Aerosol 100/5mcg/actuation | SIN14190P | AEROSOL, METERED | 0.0061mg | 7/11/2012 | |
Zenhale Pressurized Inhalation Aerosol 200/5mcg/actuation | SIN14191P | AEROSOL, METERED | 0.0061mg | 7/11/2012 | |
Zenhale Pressurized Inhalation Aerosol 50/5mcg/actuation | SIN14189P | AEROSOL, METERED | 0.0061mg | 7/11/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Tiotropium Bromide Powder for Inhalation | 国药准字H20060454 | 化学药品 | 粉雾剂 | 9/9/2020 | |
Tiotropium Bromide Inhalation Spray | 国药准字HJ20160227 | 化学药品 | 吸入喷雾剂 | 11/2/2020 | |
Tiotropium Bromide Inhalation Spray | 国药准字HJ20160226 | 化学药品 | 吸入喷雾剂 | 11/2/2020 | |
Tiotropium Bromide Powder for Inhalation | 国药准字HJ20140933 | 化学药品 | 吸入粉雾剂 | 5/13/2024 | |
Tiotropium Bromide Powder for Inhalation | 国药准字HJ20140954 | 化学药品 | 吸入粉雾剂 | 5/13/2024 | |
Tiotropium Bromide Powder for Inhalation | 国药准字H20130110 | 化学药品 | 粉雾剂 | 9/21/2023 | |
Tiotropium Bromide Powder for Inhalation | 国药准字H20090279 | 化学药品 | 粉雾剂 | 9/25/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |