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
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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 |
|---|---|---|
| spiriva | New Drug Application | 2023-02-06 |
| spiriva respimat | New Drug Application | 2023-10-02 |
| stiolto respimat | New Drug Application | 2023-05-23 |
| tiotropium bromide | ANDA | 2024-10-21 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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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 | |
| 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
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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 disease | D029424 | EFO_0000341 | J44.9 | 19 | 48 | 111 | 94 | 77 | 345 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 8 | 35 | 88 | 54 | 47 | 230 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 8 | 24 | 57 | 51 | 34 | 171 |
| Asthma | D001249 | EFO_0000270 | J45 | 2 | 13 | 17 | 9 | 12 | 52 |
| Healthy volunteers/patients | — | — | — | 19 | — | — | 1 | 1 | 21 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 3 | 1 | 8 | 3 | 2 | 17 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | 1 | 3 | 3 | 2 | 9 |
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | — | 3 | 2 | 5 |
| Chronic disease | D002908 | — | — | — | — | 2 | 2 | — | 4 |
| Bronchitis | D001991 | — | J40 | 1 | — | — | 3 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | 1 | 1 | 1 | — | — | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | 1 | — | — | 3 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | 1 | 2 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | 1 | — | — | 1 |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Airway remodeling | D056151 | — | — | — | — | — | — | 2 | 2 |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | D000080445 | — | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Bronchial hyperreactivity | D016535 | — | — | — | — | — | — | 1 | 1 |
| Smoking | D012907 | EFO_0004318 | — | — | — | — | — | 1 | 1 |
| Bronchoconstriction | D016084 | — | — | — | — | — | — | 1 | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 1 | 1 |
| Lung injury | D055370 | — | S27.30 | — | — | — | — | 1 | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
| Angle-closure glaucoma | D015812 | — | — | — | — | — | — | 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 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 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 | 411207-31-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545181 |
| ChEBI ID | — |
| PubChem CID | 5487426 |
| DrugBank | DBSALT000348 |
| UNII ID | XX112XZP0J (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
CHRM2
CHRM2
CHRM1
CHRM1
CHRM5
CHRM5
CHRM4
CHRM4
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Safety
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94,001 adverse events reported
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