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Bitolterol
Tornalate (bitolterol) is a small molecule pharmaceutical. Bitolterol was first approved as Tornalate on 1984-12-28. It is used to treat asthma and bronchial spasm in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
immune system diseasesD007154
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)
Bitolterol mesylate
Tradename
Company
Number
Date
Products
TORNALATESanofiN-018770 DISCN1984-12-28
1 products
TORNALATESanofiN-019548 DISCN1992-02-19
1 products
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
bronchial spasm—D001986—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AC: Selective beta-2-adrenoreceptor agonist inhalants
— R03AC17: Bitolterol
HCPCS
Code
Description
J7628
Bitolterol mesylate, inhalation solution, compounded product, administered through dme, concentrated form, per milligram
J7629
Bitolterol mesylate, inhalation solution, compounded product, administered through dme, unit dose form, per milligram
Clinical
Clinical Trials
77 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I501326515
HypertensionD006973EFO_0000537I10——111214
Atrial fibrillationD001281EFO_0000275I48.0——1326
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9—11215
Coronary artery diseaseD003324I25.11113—5
Blood pressureD001794EFO_0004325———2—2
Metabolic syndromeD024821EFO_0000195E88.81———2—2
Type 2 diabetes mellitusD003924EFO_0001360E11———112
St elevation myocardial infarctionD000072657———2—2
Non-st elevated myocardial infarctionD000072658———2—2
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50121——3
Cardiovascular diseasesD002318EFO_0000319I98——2——2
Diabetes mellitusD003920EFO_0000400E08-E13—11——1
CardiotoxicityD066126EFO_1001482——1——1
Duchenne muscular dystrophyD020388—11——1
Dilated cardiomyopathyD002311EFO_0000407I42.0—11——1
Chagas cardiomyopathyD002598EFO_0005529——1——1
CardiomyopathiesD009202EFO_0000318I42——1——1
Essential hypertensionD000075222I10——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute coronary syndromeD054058EFO_0005672—2———2
Familial primary pulmonary hypertensionD065627I27.011———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Heart rateD006339EFO_00043261————1
FastingD005215EFO_00027561————1
Abdominal aortic aneurysmD017544EFO_00042141————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myocardial ischemiaD017202EFO_1001375I20-I25————11
Metabolic bone diseasesD001851HP_0000938————11
Exercise testD005080EFO_0004328————11
Patient participationD010358————11
Coronary diseaseD003327————11
Congenital heart defectsD006330HP_0001627Q24.9————11
Cardiac arrhythmiasD001145EFO_0004269I49.9————11
Renal insufficiencyD051437HP_0000083N19————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBITOLTEROL
INNbitolterol
Description
Bitolterol is the di-4-toluate ester of (+-)-N-tert-butylnoradrenaline (colterol). A pro-drug for colterol, a beta2-adrenergic receptor agonist, bitolterol is used as its methanesulfonate salt for relief of bronchospasm in conditions such as asthma, chronic bronchitis and emphysema. It has a role as a bronchodilator agent, an anti-asthmatic drug, a beta-adrenergic agonist and a prodrug. It is a member of ethanolamines, a carboxylic ester, a diester, a secondary amino compound and a secondary alcohol.
Classification
Small molecule
Drug classbronchodilators (phenethylamine derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(C(=O)Oc2ccc(C(O)CNC(C)(C)C)cc2OC(=O)c2ccc(C)cc2)cc1
Identifiers
PDB—
CAS-ID30392-40-6
RxCUI19499
ChEMBL IDCHEMBL1201295
ChEBI ID3133
PubChem CID35330
DrugBankDB00901
UNII ID9KY0QXD6LI (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 55 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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24,848 adverse events reported
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