> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/tiotropium-bromide-4410d294-ab42-468c-af96-801b721fb9bd
> Record changed: 2026-10-13
# Tiotropium bromide
Highest phase reached
Approved
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
Drug type
Small molecule
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
First approval year
2004
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
## Development status
**First approval year**
2004
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
**Listing at source**
Listed
**Highest phase reached**
Approved
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
## Names and chemistry
**Drug type**
Small molecule
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
**Drug name**
Tiotropium bromide
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
**Molecular weight**
490.44
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
**Structure (SMILES)**
C\[N+\]1(C)\[C@@H\]2C\[C@@H\](OC(=O)C(O)(c3cccs3)c3cccs3)C\[C@H\]1\[C@@H\]1O\[C@@H\]12.O.\[Br-\]
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
### Brand names (6)
- braltus
- Braltus
- spiriva
- Spiriva
- spiriva respimat
- Spiriva respimat
### Other names (47)
- 1 alpha 2 beta 4 beta 5 alpha 7 beta 7 hydroxydi 2 thienylacetyl oxy 9 9 dimethyl 3 oxa 9 azoniatricyclo 3 3 1 0 sup 2 4 nonane bromide monohydrate
- 1.ALPHA., 2.BETA., 4.BETA, 5.ALPHA, 7.BETA-7-((HYDROXYDI-2-THIENYLACETYL)OXY)-9,9-DIMETHYL-3-OXA-9-AZONIATRICYCLO(3.3.1.0 SUP(2,4))NONANE BROMIDE MONOHYDRATE
- 6 beta 7 beta epoxy 3 beta hydroxy 8 methyl 1 alpha h 5 alpha h tropanium bromide di 2 thienylglycolate monohydrate
- 6.BETA.,7.BETA.-EPOXY-3.BETA.-HYDROXY-8-METHYL-1.ALPHA.H,5.ALPHA.H-TROPANIUM BROMIDE, DI-2-THIENYLGLYCOLATE MONOHYDRATE
- ba 679 br
- BA 679 BR
- ba 679br
- BA-679 BR
- BA-679-BR
- BA-679BR
- braltus
- Braltus
- bromure de tiotropium
- Bromure de tiotropium
- bromuro de tiotropio
- Bromuro de tiotropio
- Reference Product (Spiriva®)
- Spiriva
- SPIRIVA
- Spiriva Respimat
- Spiriva Respimat 2.5 μg
- Spiriva®
- Spiriva® Respimat®
- Spiriva® Respimat® 2,5 μg
- Tiotropium (Spiriva) inhalation capsule 18 ug
And 22 more, listed on the interactive page.
## Identifiers
**ChEMBL ID**
CHEMBL3545181
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
**InChIKey**
MQLXPRBEAHBZTK-SEINRUQRSA-M
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
**RxNorm IDs (RxCUI)**
- 1298831
**FDA ingredient codes (UNII)**
- L64SXO195N
### ATC classification codes (2)
- R03BB04
- R03BB54
Sources for recorded values
Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545181)
### CAS registry numbers (2)
- 186691-13-4
- 411207-31-3
## Regulatory information
### United States
**Applicant**
BOEHRINGER INGELHEIM
**Approval date**
30 Jan 2004
**Application number**
NDA021395
### Other regulatory facts
**Patents**
10
**Designations**
1
**Earliest recorded loss of exclusivity**
16 Apr 2031
**First in class**
No
**Fast track**
No
**Breakthrough designation**
No
**Orphan designation**
No
**Priority review**
No
**Orphan exclusivity**
No
**Accelerated approval**
No
**Availability**
Prescription only
## Pharmacology
### Drug classification
**Pharmacology name**
tiotropium
**Type**
Synthetic organic
**Drug name stem**
\-ium; -trop-
**Approval recorded by Guide to Pharmacology**
Yes
#### Administration routes
- topical
### Mechanisms of action (10)
- **Action type**
Antagonist
**Target**
M1 receptor
**Gene symbol**
M1 receptor
- **Action type**
Antagonist
**Target**
M2 receptor
**Gene symbol**
M2 receptor
- **Action type**
Antagonist
**Target**
M4 receptor
**Gene symbol**
M4 receptor
- **Action type**
Antagonist
**Target**
M5 receptor
**Gene symbol**
M5 receptor
- **Action**
Antagonist
**Action type**
Antagonist
**Target**
M2 receptor
**Gene symbol**
CHRM2
**Protein identifier**
P08172
**Affinity units**
pKi
- **Action**
Antagonist
**Action type**
Antagonist
**Target**
M4 receptor
**Gene symbol**
CHRM4
**Protein identifier**
P08173
**Affinity units**
pKi
- **Action**
Antagonist
**Action type**
Antagonist
**Target**
M5 receptor
**Gene symbol**
CHRM5
**Protein identifier**
P08912
**Affinity units**
pKi
- **Action**
Antagonist
**Action type**
Antagonist
**Target**
M1 receptor
**Gene symbol**
CHRM1
**Protein identifier**
P11229
**Affinity units**
pKi
- **Action**
Antagonist
**Action type**
Antagonist
**Target**
M3 receptor
**Gene symbol**
CHRM3
**Protein identifier**
P20309
**Affinity units**
pKi
**Primary target**
Yes
- **Mechanism**
Muscarinic acetylcholine receptor M3 antagonist
**Action type**
Antagonist
**Target**
Muscarinic acetylcholine receptor M3
**Protein identifier**
P20309
### Open Targets mechanisms
- **Mechanism**
Muscarinic acetylcholine receptor M3 antagonist
**Action type**
Antagonist
**Target**
Muscarinic acetylcholine receptor M3
### DrugCentral mechanisms
- **Action type**
Antagonist
**Gene symbol**
CHRM3
**Protein identifier**
P20309
**Organism**
Homo sapiens
**Target development level**
Clinical
### Investigated indications (10)
- **Condition**
Pulmonary Disease, Chronic Obstructive
**Highest recorded phase**
4
**Condition identifier**
EFO:0000341
**Subject identifier**
D029424
- **Condition**
Emphysema
**Highest recorded phase**
4
**Condition identifier**
EFO:0000464
**Subject identifier**
D004646
- **Condition**
Neoplasms
**Highest recorded phase**
2
**Condition identifier**
EFO:0000616
**Subject identifier**
D009369
- **Condition**
Bronchitis, Chronic
**Highest recorded phase**
4
**Condition identifier**
EFO:0006505
**Subject identifier**
D029481
- **Condition**
Lung Diseases, Obstructive
**Highest recorded phase**
4
**Condition identifier**
HP:0006536
**Subject identifier**
D008173
- **Condition**
Bronchial Spasm
**Highest recorded phase**
4
**Condition identifier**
HP:4000007
**Subject identifier**
D001986
- **Condition**
Asthma
**Highest recorded phase**
4
**Condition identifier**
MONDO:0004979
**Subject identifier**
D001249
- **Condition**
Bronchial Spasm
**Highest recorded phase**
4
**Condition identifier**
MONDO:0004979
**Subject identifier**
D001986
- **Condition**
Cystic Fibrosis
**Highest recorded phase**
2
**Condition identifier**
MONDO:0009061
**Subject identifier**
D003550
- **Condition**
Spinal Cord Injuries
**Highest recorded phase**
2
**Condition identifier**
MONDO:0043797
**Subject identifier**
D013119
### Open Targets indications (16)
- **Condition identifier**
EFO\_0000341
- **Condition identifier**
EFO\_0000464
- **Condition identifier**
EFO\_0000616
**Highest recorded phase**
2
- **Condition identifier**
EFO\_0006505
- **Condition identifier**
EFO\_0009661
- **Condition identifier**
HP\_0006536
- **Condition identifier**
HP\_0006536
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0003781
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0004849
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0004979
- **Condition identifier**
MONDO\_0004979
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0005002
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0005249
- **Condition identifier**
MONDO\_0005607
**Highest recorded phase**
4
- **Condition identifier**
MONDO\_0009061
**Highest recorded phase**
2
- **Condition identifier**
MONDO\_0043797
**Highest recorded phase**
2
### Reported adverse events (63)
- **Event**
asthma
**Reports**
1,870
**Reporting signal score**
5,033.83
- **Event**
asthma-chronic obstructive pulmonary disease overlap syndrome
**Reports**
73
**Reporting signal score**
346.021
- **Event**
balance disorder
**Reports**
242
**Reporting signal score**
219.456
- **Event**
benign prostatic hyperplasia
**Reports**
74
**Reporting signal score**
159.053
- **Event**
blood calcium decreased
**Reports**
169
**Reporting signal score**
335.893
- **Event**
blood count abnormal
**Reports**
550
**Reporting signal score**
1,538.13
- **Event**
blood test abnormal
**Reports**
121
**Reporting signal score**
221.948
- **Event**
breath sounds abnormal
**Reports**
95
**Reporting signal score**
230.827
- **Event**
bronchial obstruction
**Reports**
50
**Reporting signal score**
139.407
- **Event**
bronchial secretion retention
**Reports**
43
**Reporting signal score**
141.262
- **Event**
bronchial wall thickening
**Reports**
57
**Reporting signal score**
214.979
- **Event**
bronchiectasis
**Reports**
164
**Reporting signal score**
421.953
- **Event**
bronchopulmonary aspergillosis allergic
**Reports**
47
**Reporting signal score**
169.993
- **Event**
chest discomfort
**Reports**
471
**Reporting signal score**
540.411
- **Event**
chronic obstructive pulmonary disease
**Reports**
868
**Reporting signal score**
2,201.31
- **Event**
cognitive disorder
**Reports**
234
**Reporting signal score**
284.649
- **Event**
constipation
**Reports**
353
**Reporting signal score**
152.343
- **Event**
cough
**Reports**
1,152
**Reporting signal score**
1,355.41
- **Event**
creatinine renal clearance decreased
**Reports**
169
**Reporting signal score**
439.02
- **Event**
depressed level of consciousness
**Reports**
199
**Reporting signal score**
180.792
- **Event**
diarrhoea
**Reports**
116
**Reporting signal score**
139.127
- **Event**
dry mouth
**Reports**
295
**Reporting signal score**
357.227
- **Event**
dysphonia
**Reports**
187
**Reporting signal score**
180.543
- **Event**
dyspnoea
**Reports**
2,411
**Reporting signal score**
2,828.57
- **Event**
dyspnoea exacerbated
**Reports**
48
**Reporting signal score**
177.636
And 38 more, listed on the interactive page.
### Trial references (64)
- NCT00106821
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00106821)
- NCT00144326
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00144326)
- NCT00157235
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00157235)
- NCT00239408
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00239408)
- NCT00274027
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00274027)
- NCT00274079
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00274079)
- NCT00274508
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00274508)
- NCT00274573
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00274573)
- NCT00292448
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00292448)
- NCT00308191
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00308191)
- NCT00361959
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00361959)
- NCT00412204
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00412204)
- NCT00496470
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00496470)
- NCT00528996
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00528996)
- NCT00555022
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00555022)
- NCT00563381
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00563381)
- NCT00568503
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00568503)
- NCT00696020
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00696020)
- NCT00720499
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00720499)
- NCT00784550
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00784550)
- NCT01040403
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01040403)
- NCT01124422
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01124422)
- NCT01316900
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01316900)
- NCT01316913
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01316913)
- NCT01437748
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01437748)
And 39 more, listed on the interactive page.
## Dosing
**Dose**
2 inhalations of 2.5 mcg or 1.25 mcg per actuation
**Route**
Inhalation
**How often**
Once daily
### Conditions of use (2)
- Administer as two inhalations
- Do not exceed 2 inhalations in 24 hours
## Chemical properties
**Hydrogen bond acceptors**
6
**Hydrogen bond donors**
1
**Polar surface area**
59.06
**Calculated partition coefficient (ALogP)**
2.35
**Prodrug**
No
**Chirality**
Single enantiomer
**Inorganic**
No
**Rule-of-five violations**
0
**Rotatable bonds**
4
**Heavy atoms**
28
**Molecular formula**
C19H24BrNO5S2
**Natural product**
No
## National Drug Codes
- 0597-0075
- 0597-0155
- 68180-964
- 50090-4248
- 50090-7645
## Biological measurements
### Observed measurements
#### Plasma protein binding
**Median**
48
**Mean**
48
**Minimum**
48
**Maximum**
48
**Unit**
%
**Assays**
2
**Standard deviation**
0
**Summary method**
median
**Censored results excluded**
0
**Other units excluded**
0
**Unknown units excluded**
0
#### Measurement types
- PPB
## Related records
### Trials (120)
- 12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients. Correlation to Dyspnoea Scales
- 24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo
- 24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease
- 24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
- 24hr Effects of Tiotropium Bromide in Tetraplegia
- 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).
- 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
- A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease
- A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
- A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
- A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD
- A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD
- A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules (Spiriva) on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma
- A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol
- A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)
- [A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions](https://trialight.com/data/trial/a-trial-to-assess-the-bioequivalence-of-tiotropium-bromide-2391d77a-ea87-4a57-8bbc-44e6ac070b50.md)
- An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
### Approved for (5)
- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md)
- [Chronic bronchitis](https://trialight.com/data/condition/chronic-bronchitis-1182c6a7-3657-5c56-89e7-6c969a2220da.md)
- [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md)
- Obstructive lung disease
- [Pulmonary emphysema](https://trialight.com/data/condition/pulmonary-emphysema-7c09e667-0ffb-5ac1-bbd4-bd87b4f05fc6.md)
### In development for (3)
- [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Phase 2
- Neoplasm Phase 2
- Spinal cord injury Phase 2
### Other linked conditions (1)
- [Bronchitis](https://trialight.com/data/condition/bronchitis-521c8a00-6a48-5246-b908-ec54f125daf0.md)
### Targets (1)
- [CHRM3](https://trialight.com/data/target/chrm3-0610da06-d23d-5bc0-b133-4b5bb330f58e.md) Muscarinic acetylcholine receptor M3 antagonist
---
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