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Drug ReportsCyclopentolate
Cyclopentolate
Akpentolate, Cyclogyl, Cyclomydril, Pentolair (cyclopentolate) is a small molecule pharmaceutical. Cyclopentolate was first approved as Cyclogyl on 1982-01-01.
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Financial
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Events Timeline
5D
1M
3M
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YTD
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2Y
5Y
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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
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Trade Name
FDA
EMA
Akpentolate, Cyclogyl, Pentolair (discontinued: Ak-pentolate, Cyclopentolate)
Combinations
Cyclomydril
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
ak-pentolateANDA2010-09-01
cyclogylANDA2024-06-25
cyclomydrilANDA2023-12-14
cyclopentolateANDA2022-01-25
cyclopentolate hydrochlorideANDA2022-09-29
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01F: Mydriatics and cycloplegics
— S01FA: Anticholinergic mydriatics and cycloplegics
— S01FA04: Cyclopentolate
— S01FA54: Cyclopentolate, combinations
HCPCS
No data
Clinical
Clinical Trials
26 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CataractD002386HP_0000518H26.9—11147
MydriasisD015878HP_0011499H57.04——1247
Refractive errorsD012030EFO_0003908H52.71——214
Retinopathy of prematurityD012178EFO_1001158H35.1———112
Vision disordersD014786HP_0000505H53.11———112
Drug-related side effects and adverse reactionsD064420—T88.7———1—1
EsotropiaD004948HP_0000565H50.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230——1—1——2
InfectionsD007239EFO_0000544———1——1
Communicable diseasesD003141————1——1
KeratitisD007634HP_0000491H16——1——1
Corneal endothelial cell lossD055954————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MiosisD015877HP_0000616H57.03—1———1
DemoralizationD000079224———1———1
DepressionD003863—F33.9—1———1
Major depressive disorderD003865EFO_0003761F22—1———1
Depressive disorderD003866EFO_1002014F32.A—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951————1
Myelodysplastic syndromesD009190—D461————1
Myeloid leukemia acuteD015470—C92.01————1
Hematologic neoplasmsD019337——1————1
Prostatic neoplasmsD011471—C611————1
RecurrenceD012008——1————1
Castration-resistant prostatic neoplasmsD064129——1————1
CarcinomaD002277—C80.01————1
Breast neoplasmsD001943EFO_0003869C501————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Show 35 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pathologic dilatationD004108——————11
Retinal diseasesD012164HP_0000479H35.9————11
Premature birthD047928EFO_0003917O60————11
Cataract extractionD002387——————11
StrabismusD013285HP_0000486H50.2————11
AmblyopiaD000550HP_0000646H53.00————11
AnisometropiaD015858HP_0012803H52.31————11
Macular degenerationD008268EFO_0001365H35.30————11
Hyperemesis gravidarumD006939EFO_1000971O21————11
Hereditary corneal dystrophiesD003317HP_0007802H18.5————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCyclopentolate
INNcyclopentolate
Description
Cyclopentolate is a carboxylic ester resulting from the formal condensation of (1-hydroxycyclopentyl)(phenyl)acetic acid with N,N-dimethylethanolamine. A tertiary amine antimuscarinic with actions similar to atropine, it is used as its hydrochloride salt to produce mydriasis (excessive dilation of the pupil) and cycloplegia (paralysis of the ciliary muscle of the eye) for opthalmic diagnostic procedures. It acts more quickly than atropine and has a shorter duration of action. It has a role as a mydriatic agent, a parasympatholytic, a muscarinic antagonist and a diagnostic agent. It is a carboxylic ester, a tertiary amino compound and a tertiary alcohol. It is functionally related to a (1-hydroxycyclopentyl)phenylacetic acid and a N,N-dimethylethanolamine.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
CN(C)CCOC(=O)C(c1ccccc1)C1(O)CCCC1
Identifiers
PDB—
CAS-ID512-15-2
RxCUI—
ChEMBL IDCHEMBL1201338
ChEBI ID4024
PubChem CID2905
DrugBankDB00979
UNII IDI76F4SHP7J (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Cyclopentolate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Cyclopentolate
+
Phenylephrine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,778 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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880 adverse events reported
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