Tiotropium
Spiriva, Stiolto (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
Trade Name
FDA
EMA
Spiriva
CombinationsStiolto
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 RESPIMAT | Boehringer Ingelheim | N-206756 RX | 2015-05-21 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| spiriva respimat | New Drug Application | 2023-05-23 |
| stiolto respimat | New Drug Application | 2020-10-20 |
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 | |
| 7896264 | 2025-05-26 | DP | |
| 7220742 | 2025-05-12 | DS, DP | U-1703 |
| 8034809 | 2025-05-12 | U-1702 | |
| 7284474 | 2024-08-26 | DP | |
| 7056916 | 2023-12-07 | DS, DP | |
| 7491719 | 2023-11-10 | DS, DP | |
| 7786111 | 2023-11-10 | DP | |
| 8044046 | 2023-11-10 | U-1702 | |
| 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
No data
Clinical
Clinical Trials
212 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 1 | 6 | 16 | 7 | 15 | 44 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | — | 3 | 10 | 13 | 16 | 41 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | 1 | 2 | 7 | 7 | 7 | 23 |
| Neoplasms | D009369 | C80 | 1 | 5 | 4 | 2 | 6 | 17 | |
| Thromboembolism | D013923 | HP_0001907 | — | 2 | 7 | 3 | 3 | 14 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | 2 | 1 | 9 | 13 | |
| Thrombosis | D013927 | — | 2 | 2 | 3 | 5 | 12 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 3 | 3 | 2 | — | 7 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | 2 | 3 | 7 |
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | 4 | 1 | — | 6 |
Show 26 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Proliferative vitreoretinopathy | D018630 | EFO_1001129 | — | — | 3 | — | — | 3 | |
| Colorectal neoplasms | D015179 | — | — | 3 | — | — | 3 | ||
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 1 | — | 1 | 2 | |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | 1 | — | 1 | 2 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | 1 | 2 |
| Thrombophilia | D019851 | D68.59 | — | — | 1 | — | 1 | 2 | |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | 1 | 1 | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | 1 | — | — | 2 |
| Pregnancy complications | D011248 | — | — | 1 | — | 1 | 2 | ||
| Diabetic foot | D017719 | EFO_1001459 | — | 2 | 2 | — | — | 2 |
Show 26 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | — | 2 | — | — | 2 | 4 | |
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | 1 | 2 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | — | 1 | 2 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | — | — | — | 1 | |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | C15 | — | 1 | — | — | — | 1 | |
| Duodenal neoplasms | D004379 | — | 1 | — | — | — | 1 | ||
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | 1 | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | C24.9 | — | 1 | — | — | — | 1 | |
| Ampulla of vater cancer | — | — | 1 | — | — | — | 1 |
Show 9 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | 1 | — | — | — | 2 | 3 |
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
| Renal cell carcinoma | D002292 | 1 | — | — | — | — | 1 | ||
| Pseudotumor cerebri | D011559 | EFO_1001132 | G93.2 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | — | — | 2 | 2 |
| Inflammation | D007249 | — | — | — | — | 2 | 2 | ||
| Embolism | D004617 | — | — | — | — | 1 | 1 | ||
| Cytokine release syndrome | D000080424 | D89.83 | — | — | — | — | 1 | 1 | |
| Undifferentiated connective tissue diseases | D000074079 | — | — | — | — | 1 | 1 | ||
| Urolithiasis | D052878 | N20-N23 | — | — | — | — | 1 | 1 | |
| Fertilization in vitro | D005307 | — | — | — | — | 1 | 1 | ||
| Assisted reproductive techniques | D027724 | — | — | — | — | 1 | 1 | ||
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | — | — | — | — | 1 | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | 1 | 1 |
Show 16 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TIOTROPIUM |
| INN | tiotropium 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 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 | 69120 |
| ChEMBL ID | CHEMBL1900528 |
| ChEBI ID | — |
| PubChem CID | 3086655 |
| DrugBank | DB01409 |
| UNII ID | XX112XZP0J (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
CHRM2
CHRM2
CHRM5
CHRM5
CHRM1
CHRM1
CHRM4
CHRM4
Variants
Clinical Variant
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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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2,314 adverse events reported
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