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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Spiriva, Tiotropium
CombinationsStiolto
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 |
|---|---|---|---|---|
| SPIRIVA | Boehringer Ingelheim | N-021395 RX | 2004-01-30 | 1 products, RLD, RS |
| SPIRIVA RESPIMAT | Boehringer Ingelheim | N-021936 RX | 2014-09-24 | 2 products, RLD, RS |
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 | New Drug Application | 2025-09-02 |
| spiriva respimat | New Drug Application | 2025-01-07 |
| stiolto respimat | New Drug Application | 2025-06-30 |
| tiotropium bromide | ANDA | 2025-04-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic bronchitis | — | D029481 | J42 |
| pulmonary emphysema | — | D011656 | J43 |
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 | |
| 7220742 | 2025-05-12 | DS, DP | U-1703 |
| 8034809 | 2025-05-12 | U-1702 | |
| Tiotropium Bromide, Spiriva, Boehringer Ingelheim | |||
| 8022082 | 2026-01-19 | DP | U-1186 |
| Tiotropium Bromide, Spiriva Respimat, Boehringer Ingelheim | |||
| 7896264 | 2025-05-26 | DP | |
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
426 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 | 4 | 17 | 60 | 38 | 48 | 167 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 4 | 15 | 46 | 25 | 29 | 119 |
| Obstructive lung diseases | D008173 | — | — | 2 | 2 | 17 | 18 | 13 | 52 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 9 | 10 | 1 | 5 | 25 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 1 | 1 | 4 | 1 | — | 7 |
| Dyspnea | D004417 | — | R06.0 | — | — | 2 | 2 | 1 | 5 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | 1 | — | 1 |
| Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | — | 1 |
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 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Chronic bronchitis | D029481 | — | J42 | 1 | — | — | — | — | 1 |
| Bronchitis | D001991 | — | J40 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | — | — | 1 | 1 |
| Pulmonary emphysema | D011656 | — | J43 | — | — | — | — | 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 |
| 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 |
Identifiers
| PDB | — |
| CAS-ID | 186691-13-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1900528 |
| ChEBI ID | — |
| PubChem CID | 5487426 |
| DrugBank | DBSALT000348 |
| UNII ID | XX112XZP0J (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
CHRM2
CHRM2
CHRM5
CHRM5
CHRM1
CHRM1
CHRM4
CHRM4
Variants
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Financial
Revenue by drug
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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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Tiotropium
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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52,610 adverse events reported
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