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Drug ReportsDicyclomine
Dicyclomine
Bentyl, Dicyclomine (dicyclomine) is a small molecule pharmaceutical. Dicyclomine was first approved as Dicyclomine hydrochloride on 1982-01-01. It is used to treat irritable bowel syndrome in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M1 and muscarinic acetylcholine receptor M3. In addition, it is known to target muscarinic acetylcholine receptor M2 and muscarinic acetylcholine receptor M4.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
Trade Name
FDA
EMA
Bentyl (generic drugs available since 1982-01-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dicyclomine hydrochloride
Tradename
Company
Number
Date
Products
BENTYLAbbVieN-008370 RX1984-10-15
1 products, RLD, RS
BENTYL PRESERVATIVE FREEAbbVieN-008370 RX1984-10-15
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bentylNew Drug Application2023-02-04
dicyclomineANDA2023-03-14
dicyclomine dicyclomine hydrochlorideANDA2014-10-21
dicyclomine hclANDA2023-09-22
dicyclomine hydrochlorideANDA2024-02-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
irritable bowel syndromeEFO_0000555D043183K58
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A03: Drugs for functional gastrointestinal disorders
— A03A: Drugs for functional gastrointestinal disorders
— A03AA: Synthetic anticholinergics, esters with tertiary amino group for functional gastrointestinal disorders
— A03AA07: Dicycloverine
HCPCS
Code
Description
J0500
Injection, dicyclomine hcl, up to 20 mg
Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Morning sicknessD048968—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VomitingD014839HP_0002013R11.1——1——1
Hyperemesis gravidarumD006939EFO_1000971O21——1——1
PregnancyD011247EFO_0002950Z33.1——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Biological availabilityD001682——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDicyclomine
INNdicycloverine
Description
Dicyclomine is the ester resulting from the formal condensation of 1-cyclohexylcyclohexanecarboxylic acid with 2-(diethylamino)ethanol. An anticholinergic, it is used as the hydrochloride to treat or prevent spasm in the muscles of the gastrointestinal tract, particularly that associated with irritable bowel syndrome. It has a role as a muscarinic antagonist, an antispasmodic drug and a parasympatholytic. It is a tertiary amine and a carboxylic ester. It is functionally related to a 2-diethylaminoethanol and a 1,1'-bi(cyclohexyl)-1-carboxylic acid.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCN(CC)CCOC(=O)C1(C2CCCCC2)CCCCC1
Identifiers
PDB—
CAS-ID77-19-0
RxCUI—
ChEMBL IDCHEMBL1123
ChEBI ID4514
PubChem CID3042
DrugBankDB00804
UNII ID4KV4X8IF6V (ChemIDplus, GSRS)
Target
Agency Approved
CHRM1
CHRM1
CHRM3
CHRM3
Organism
Homo sapiens
Gene name
CHRM1
Gene synonyms
NCBI Gene ID
1128
Protein name
muscarinic acetylcholine receptor M1
Protein synonyms
acetylcholine receptor, muscarinic 1
Uniprot ID
Q96RH1
Mouse ortholog
Chrm1 (12669)
muscarinic acetylcholine receptor M1 (Q8BJN3)
Alternate
CHRM2
CHRM2
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
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Dicyclomine
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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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,062 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,289 adverse events reported
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