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Drug ReportsTiotropium bromide
Tiotropium bromide
Spiriva, Stiolto, Tiotropium (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
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
spirivaNew Drug Application2025-01-07
spiriva respimatNew Drug Application2025-01-07
stiolto respimatNew Drug Application2025-02-21
tiotropium bromideANDA2024-10-21
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
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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
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9——1——1
Obstructive lung diseasesD008173————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTiotropium bromide
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.O.[Br-]
Identifiers
PDB—
CAS-ID411207-31-3
RxCUI—
ChEMBL IDCHEMBL3545181
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
CHRM1
CHRM1
CHRM5
CHRM5
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
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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95,741 adverse events reported
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