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Drug ReportsTiotropium
Tiotropium
Spiriva, Stiolto, Tiotropium (tiotropium) is a small molecule pharmaceutical. Tiotropium 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 M5, muscarinic acetylcholine receptor M1, and muscarinic acetylcholine receptor M4.
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Target
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Financial
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3M
6M
YTD
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2Y
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EMA approval date
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Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Spiriva, Tiotropium
Combinations
Stiolto
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Olodaterol hydrochloride
+
Tiotropium bromide
Tradename
Company
Number
Date
Products
STIOLTO RESPIMATBoehringer IngelheimN-206756 RX2015-05-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
spirivaNew Drug Application2023-02-06
spiriva respimatNew Drug Application2023-10-02
stiolto respimatNew Drug Application2023-05-23
tiotropium bromideANDA2024-10-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic bronchitis—D029481J42
pulmonary emphysema—D011656J43
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
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
428 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_0000341J44.919481119477345
Lung diseasesD008171HP_0002088J98.4835885447230
Obstructive lung diseasesD008173HP_0006536—824575134171
AsthmaD001249EFO_0000270J452131791252
Healthy volunteers/patients———19——1121
Respiratory aspirationD053120EFO_1001839—3183217
DyspneaD004417HP_0002094R06.0—13329
EmphysemaD004646EFO_0000464J43———325
Chronic diseaseD002908————22—4
BronchitisD001991—J401——3—4
Show 15 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD005355——111——3
Cystic fibrosisD003550EFO_0000390E84111——3
Cardiovascular diseasesD002318HP_0001626———1—12
Respiratory insufficiencyD012131HP_0002093J96.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal cord injuriesD013119EFO_1001919—11———2
Non-small-cell lung carcinomaD002289———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Airway remodelingD056151——————22
Asthma-chronic obstructive pulmonary disease overlap syndromeD000080445——————11
ObesityD009765EFO_0001073E66.9————11
Bronchial hyperreactivityD016535——————11
SmokingD012907EFO_0004318—————11
BronchoconstrictionD016084——————11
TuberculosisD014376EFO_0000774A15-A19————11
Lung injuryD055370—S27.30————11
GlaucomaD005901EFO_0000516H40————11
Angle-closure glaucomaD015812——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTiotropium
INNtiotropium bromide
Description
Tiotropium bromide is an organic bromide salt having (1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane as the counterion. Used (in the form of the hydrate) for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. It has a role as a bronchodilator agent and a muscarinic antagonist. It is an organic bromide salt and a quaternary ammonium salt.
Classification
Small molecule
Drug classquaternary ammonium derivatives; atropine derivatives
Image (chem structure or protein)Loading
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
Identifiers
PDB—
CAS-ID186691-13-4
RxCUI—
ChEMBL IDCHEMBL1900528
ChEBI ID—
PubChem CID5487426
DrugBankDBSALT000348
UNII IDXX112XZP0J (ChemIDplus, GSRS)
Target
Agency Approved
CHRM3
CHRM3
Organism
Homo sapiens
Gene name
CHRM3
Gene synonyms
NCBI Gene ID
1131
Protein name
muscarinic acetylcholine receptor M3
Protein synonyms
acetylcholine receptor, muscarinic 3, m3 muscarinic receptor
Uniprot ID
Q9HB60
Mouse ortholog
Chrm3 (12671)
muscarinic acetylcholine receptor M3 (Q9ERZ3)
Alternate
CHRM2
CHRM2
CHRM5
CHRM5
CHRM1
CHRM1
CHRM4
CHRM4
Organism
Homo sapiens
Gene name
CHRM2
Gene synonyms
NCBI Gene ID
1129
Protein name
muscarinic acetylcholine receptor M2
Protein synonyms
7TM receptor, acetylcholine receptor, muscarinic 2, muscarinic M2 receptor
Uniprot ID
Q9P1X9
Mouse ortholog
Chrm2 (243764)
muscarinic acetylcholine receptor M2 (Q9ERZ4)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Tiotropium
+
Olodaterol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tiotropium
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,023 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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94,001 adverse events reported
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