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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
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Spiriva
Combinations
Stiolto
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 RESPIMATBoehringer IngelheimN-206756 RX2015-05-21
1 products, RLD, RS
Tiotropium bromide
Tradename
Company
Number
Date
Products
SPIRIVABoehringer IngelheimN-021395 RX2004-01-30
1 products, RLD, RS
SPIRIVA RESPIMATBoehringer IngelheimN-021936 RX2014-09-24
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
spiriva respimatNew Drug Application2023-05-23
stiolto respimatNew Drug Application2020-10-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic bronchitisD029481J42
pulmonary emphysemaD011656J43
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Olodaterol Hydrochloride / Tiotropium Bromide, Stiolto Respimat, Boehringer Ingelheim
87333412030-10-16DP
78372352028-03-13DP
90279672027-03-31DP
77279842027-01-19DP
73963412026-10-10DP
78962642025-05-26DP
72207422025-05-12DS, DPU-1703
80348092025-05-12U-1702
72844742024-08-26DP
70569162023-12-07DS, DP
74917192023-11-10DS, DP
77861112023-11-10DP
80440462023-11-10U-1702
Tiotropium Bromide, Spiriva, Boehringer Ingelheim
90103232030-04-19DP
76946762027-03-12DP
80220822026-01-19DPU-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 diseaseD029424EFO_0000341J44.913431048439279
AsthmaD001249EFO_0000270J45212177744
Healthy volunteers/patients191121
EmphysemaD004646EFO_0000464J43213
Disease progressionD018450112
Chronic bronchitisD029481J42112
BronchiectasisD001987HP_0002110J4711
Respiratory soundsD012135HP_0010307R06.111
Airway obstructionD00040211
Pulmonary emphysemaD011656J4311
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E841113
Obstructive lung diseasesD008173HP_0006536122
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal cord injuriesD013119EFO_1001919112
Non-small-cell lung carcinomaD00228911
DyspneaD004417HP_0002094R06.011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N1911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.911
Bronchial hyperreactivityD01653511
Cardiovascular diseasesD002318EFO_0000319I9811
SmokingD012907EFO_0003768F1711
Airway remodelingD05615111
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTIOTROPIUM BROMIDE
INNtiotropium 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 classquaternary 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-ID186691-13-4
RxCUI69120
ChEMBL IDCHEMBL3545181
ChEBI ID
PubChem CID3086655
DrugBankDB01409
UNII IDXX112XZP0J (ChemIDplus, GSRS)
Target
Agency Approved
CHRM3
CHRM3
Organism
Homo sapiens
Gene name
CHRM3
Gene synonyms
NCBI Gene ID
Protein name
muscarinic acetylcholine receptor M3
Protein synonyms
acetylcholine receptor, muscarinic 3, m3 muscarinic receptor
Uniprot ID
Mouse ortholog
Chrm3 (12671)
muscarinic acetylcholine receptor M3 (Q9ERZ3)
Alternate
CHRM2
CHRM2
CHRM1
CHRM1
CHRM5
CHRM5
CHRM4
CHRM4
Organism
Homo sapiens
Gene name
CHRM2
Gene synonyms
NCBI Gene ID
Protein name
muscarinic acetylcholine receptor M2
Protein synonyms
7TM receptor, acetylcholine receptor, muscarinic 2, muscarinic M2 receptor
Uniprot ID
Mouse ortholog
Chrm2 (243764)
muscarinic acetylcholine receptor M2 (Q9ERZ4)
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
Mock data
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34,791 adverse events reported
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