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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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Akpentolate, Cyclogyl, Pentolair (discontinued: Ak-pentolate, Cyclopentolate)
CombinationsCyclomydril
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ak-pentolate | ANDA | 2010-09-01 |
| cyclogyl | ANDA | 2024-06-25 |
| cyclomydril | ANDA | 2023-12-14 |
| cyclopentolate | ANDA | 2022-01-25 |
| cyclopentolate hydrochloride | ANDA | 2022-09-29 |
Indications
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Agency Specific
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Patent Expiration
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Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cataract | D002386 | EFO_0001059 | H26.9 | — | 1 | 1 | 1 | 4 | 7 |
| Mydriasis | D015878 | — | H57.04 | — | — | 1 | 2 | 4 | 7 |
| Refractive errors | D012030 | HP_0000483 | H52.7 | 1 | — | — | 2 | 1 | 4 |
| Retinopathy of prematurity | D012178 | EFO_1001158 | H35.1 | — | — | — | 1 | 1 | 2 |
| Vision disorders | D014786 | — | H53.11 | — | — | — | 1 | 1 | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | 1 | — | 1 |
| Esotropia | D004948 | — | H50.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Keratitis | D007634 | — | H16 | — | — | 1 | — | — | 1 |
| Corneal endothelial cell loss | D055954 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal diseases | D012164 | — | H35.9 | 1 | — | — | — | 1 | 2 |
| Nervous system diseases | D009422 | — | G00-G99 | 2 | — | — | — | — | 2 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
| Primary dysautonomias | D054969 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic intolerance | D054971 | — | — | 1 | — | — | — | — | 1 |
| Optic nerve diseases | D009901 | EFO_1001330 | H47.14 | 1 | — | — | — | — | 1 |
| General anesthesia | D000768 | — | — | 1 | — | — | — | — | 1 |
| Myopia | D009216 | EFO_0003927 | H52.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 1 | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | — | — | 1 | 1 |
| Cataract extraction | D002387 | — | — | — | — | — | — | 1 | 1 |
| Strabismus | D013285 | — | H50.2 | — | — | — | — | 1 | 1 |
| Amblyopia | D000550 | — | H53.00 | — | — | — | — | 1 | 1 |
| Anisometropia | D015858 | — | H52.31 | — | — | — | — | 1 | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
| Hyperemesis gravidarum | D006939 | EFO_1000971 | O21 | — | — | — | — | 1 | 1 |
| Hereditary corneal dystrophies | D003317 | — | H18.5 | — | — | — | — | 1 | 1 |
| Paralysis | D010243 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cyclopentolate |
| INN | cyclopentolate |
| 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 | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCOC(=O)C(c1ccccc1)C1(O)CCCC1 |
Identifiers
| PDB | — |
| CAS-ID | 512-15-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201338 |
| ChEBI ID | 4024 |
| PubChem CID | 2905 |
| DrugBank | DB00979 |
| UNII ID | I76F4SHP7J (ChemIDplus, GSRS) |
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Cyclopentolate
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Cyclopentolate
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Phenylephrine
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Safety
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905 adverse events reported
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