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Tiotropium

Generic Name
Tiotropium
Brand Names
Inspiolto Respimat, Spiriva, Spiriva Respimat, Stiolto
Drug Type
Small Molecule
Chemical Formula
C19H22NO4S2
CAS Number
186691-13-4
Unique Ingredient Identifier
0EB439235F

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Withdrawn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.

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.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
SRIVASSO tiotropium 18 micrograms powder for inhalation (in capsule) blister pack
269417
Medicine
A
6/8/2016
TIOVA tiotropium (as bromide monohydrate) 18 microgram powder for inhalation (in capsule) blister pack
393302
Medicine
A
9/1/2023
SPIOLTO RESPIMAT 2.5 micrograms/2.5 micrograms tiotropium (as bromide monohydrate)/olodaterol (as hydrochloride) solution for inhalation cartridge (with dose indicator)
326008
Medicine
A
3/4/2020
ESOVYND RESPIMAT tiotropium 2.5 micrograms/actuation solution for inhalation cartridge (with dose indicator)
325663
Medicine
A
3/4/2020
BRALTUS tiotropium (as bromide) 13 microgram powder for inhalation hard capsule
293317
Medicine
A
11/15/2018
CIP TIOTROPIUM tiotropium (as bromide monohydrate) 18 microgram powder for inhalation (in capsule) blister pack
393295
Medicine
A
9/1/2023
TIOTROPIUM GH tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule inhaler
393050
Medicine
A
8/28/2023
TIOTROPIUM LUPIN tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule inhaler
393051
Medicine
A
8/28/2023
SPIRIVA RESPIMAT tiotropium 2.5 micrograms/actuation solution for inhalation cartridge (with dose indicator)
325662
Medicine
A
3/4/2020
SRIVASSO RESPIMAT tiotropium 2.5 micrograms/actuation solution for inhalation cartridge (with dose indicator)
325664
Medicine
A
3/4/2020
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