Tiotropium bromide
Spiriva, Stiolto (tiotropium bromide) is a small molecule pharmaceutical. Tiotropium bromide was first approved as Spiriva on 2004-01-30. It is used to treat chronic bronchitis and pulmonary emphysema in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M3. In addition, it is known to target muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M1, muscarinic acetylcholine receptor M5, and muscarinic acetylcholine receptor M4.
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Commercial
Trade Name
FDA
EMA
Spiriva
CombinationsStiolto
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Olodaterol hydrochloride
+
Tiotropium bromide
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
STIOLTO RESPIMAT | Boehringer Ingelheim | N-206756 RX | 2015-05-21 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
spiriva respimat | New Drug Application | 2023-05-23 |
stiolto respimat | New Drug Application | 2020-10-20 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Olodaterol Hydrochloride / Tiotropium Bromide, Stiolto Respimat, Boehringer Ingelheim | |||
8733341 | 2030-10-16 | DP | |
7837235 | 2028-03-13 | DP | |
9027967 | 2027-03-31 | DP | |
7727984 | 2027-01-19 | DP | |
7396341 | 2026-10-10 | DP | |
7896264 | 2025-05-26 | DP | |
7220742 | 2025-05-12 | DS, DP | U-1703 |
8034809 | 2025-05-12 | U-1702 | |
7284474 | 2024-08-26 | DP | |
7056916 | 2023-12-07 | DS, DP | |
7491719 | 2023-11-10 | DS, DP | |
7786111 | 2023-11-10 | DP | |
8044046 | 2023-11-10 | U-1702 | |
Tiotropium Bromide, Spiriva, Boehringer Ingelheim | |||
9010323 | 2030-04-19 | DP | |
7694676 | 2027-03-12 | DP | |
8022082 | 2026-01-19 | DP | U-1186 |
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL06: Olodaterol and tiotropium bromide
— R03AL10: Formoterol and tiotropium bromide
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BB: Anticholinergics inhalants for obstructive airway diseases
— R03BB04: Tiotropium bromide
— R03BB54: Tiotropium bromide, combinations
HCPCS
No data
Clinical
Clinical Trials
352 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 13 | 43 | 104 | 84 | 39 | 279 |
Asthma | D001249 | EFO_0000270 | J45 | 2 | 12 | 17 | 7 | 7 | 44 |
Healthy volunteers/patients | — | 19 | — | — | 1 | 1 | 21 | ||
Emphysema | D004646 | EFO_0000464 | J43 | — | — | — | 2 | 1 | 3 |
Disease progression | D018450 | — | — | — | 1 | 1 | 2 | ||
Chronic bronchitis | D029481 | J42 | 1 | — | — | 1 | — | 2 | |
Bronchiectasis | D001987 | HP_0002110 | J47 | — | — | — | 1 | — | 1 |
Respiratory sounds | D012135 | HP_0010307 | R06.1 | — | — | — | 1 | — | 1 |
Airway obstruction | D000402 | — | — | — | 1 | — | 1 | ||
Pulmonary emphysema | D011656 | J43 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | 1 | — | — | 3 |
Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Spinal cord injuries | D013119 | EFO_1001919 | 1 | 1 | — | — | — | 2 | |
Non-small-cell lung carcinoma | D002289 | — | 1 | — | — | — | 1 | ||
Dyspnea | D004417 | HP_0002094 | R06.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Bronchial hyperreactivity | D016535 | — | — | — | — | 1 | 1 | ||
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
Smoking | D012907 | EFO_0003768 | F17 | — | — | — | — | 1 | 1 |
Airway remodeling | D056151 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TIOTROPIUM BROMIDE |
INN | tiotropium bromide |
Description | Tiotropium bromide, sold under the brand name Spiriva among others, is a long-acting bronchodilator (LAMA: long acting muscarinic antagonist) used in the management of chronic obstructive pulmonary disease (COPD) and asthma. Specifically it is used during periods of breathing difficulty to prevent them from getting worse, rather than to prevent them from happening. It is used by inhalation through the mouth. Onset typically begins within half an hour and lasts for 24 hours.
|
Classification | Small molecule |
Drug class | quaternary ammonium derivatives; atropine derivatives |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | C[N+]1(C)[C@H]2C[C@H](OC(=O)C(O)(c3cccs3)c3cccs3)C[C@@H]1[C@H]1O[C@@H]21.O.[Br-] |
Identifiers
PDB | — |
CAS-ID | 186691-13-4 |
RxCUI | 69120 |
ChEMBL ID | CHEMBL3545181 |
ChEBI ID | — |
PubChem CID | 3086655 |
DrugBank | DB01409 |
UNII ID | XX112XZP0J (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
CHRM2
CHRM2
CHRM1
CHRM1
CHRM5
CHRM5
CHRM4
CHRM4
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,927 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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34,791 adverse events reported
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