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cyclopentolate

Trade name: cyclogyl

Small moleculeapproved

Approved

Jul 31, 1974

Cyclopentolate (cyclopentolate hydrochloride) is a parasympatholytic anticholinergic used solely to obtain mydriasis or cycloplegia. This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides. — NCATS

Clinical trial activity

13 trials · 16 clinical orgs · 10 marketing orgs

Phase 1
1
Phase 2
2
Phase 3
1
Phase 4
5

Earliest trial started Dec 1, 2005 (NCT00348166)

Timeline

1970s

  1. Jul 31, 1974

    Alcon — Earliest FDA Approval

  2. Jul 31, 1974

    Alcon — Marketing Organization

  3. Jul 31, 1974

    Alcon — NDA Organization

  4. Nov 22, 1974

    Johnson and Johnson — Marketing Organization

  5. Apr 10, 1979

    Epic Pharma Llc — Marketing Organization

1990s

  1. Jan 24, 1991

    Nestle — Marketing Organization

  2. Apr 29, 1994

    Bausch & Lomb — Marketing Organization

  3. Jan 13, 1997

    Rising Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Dec 9, 2015

    Akorn, Inc. — Marketing Organization

  2. Dec 9, 2015

    Sciegen Pharmaceticals — Marketing Organization

  3. Dec 9, 2015

    Saptalis Pharmaceuticals — Marketing Organization

  4. Jan 1, 2016

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 2019

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 31, 1974

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CCOC(=O)C(c1ccccc1)C1(O)CCCC1
Mol. weight
291.39 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1-hydroxy-alpha-phenylcyclopentaneacetic acid 2-(dimethylamino)ethyl ester
  • 1-hydroxy-alpha-phenylcyclopentaneacetic acid 2-(dimethylamino)ethyl ester
  • 2-(dimethylamino)ethyl 1-hydroxy-alpha-phenylcyclopentaneacetate
  • 2-(dimethylamino)ethyl 1-hydroxy-alpha-phenylcyclopentaneacetate
  • 2-(dimethylamino)ethyl 2-(1-hydroxycyclopentyl)-2-phenylacetate
  • 2-(dimethylamino)ethyl 2-(1-hydroxycyclopentyl)-2-phenylacetate
  • 2-phenyl-2-(1-hydroxycyclopentyl)ethanoic acid beta-(dimethylamino)ethyl ester
  • 2-phenyl-2-(1-hydroxycyclopentyl)ethanoic acid beta-(dimethylamino)ethyl ester
  • akpentolate
  • akpentolate
  • ak-pentolate
  • ak-pentolate
  • alnide
  • alnide
  • alpha-(1-hydroxycyclopentyl)benzeneacetic acid 2-(dimethylamino)ethyl ester
  • alpha-(1-hydroxycyclopentyl)benzeneacetic acid 2-(dimethylamino)ethyl ester
  • beta-(dimethylamino)ethyl (1-hydroxycyclopentyl)phenylacetate
  • beta-(dimethylamino)ethyl (1-hydroxycyclopentyl)phenylacetate
  • beta-dimethylaminoethyl (1-hydroxycyclopentyl)phenylacetate
  • beta-dimethylaminoethyl (1-hydroxycyclopentyl)phenylacetate
  • ciclopentolato
  • ciclopentolato
  • cyclogyl
  • cyclogyl
  • cyclogyl
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • cyclopentolate
  • (+-)-cyclopentolate
  • (+-)-cyclopentolate
  • (±)-cyclopentolate
  • (±)-cyclopentolate
  • cyclopentolate hcl
  • cyclopentolate hcl
  • cyclopentolate hcl
  • cyclopentolatehydrochloride
  • cyclopentolate hydrochloride
  • cyclopentolate hydrochloride
  • cyclopentolate hydrochloride
  • cyclopentolate hydrochloride
  • cyclopentolatum
  • cyclopentolatum
  • cyclopentylate
  • mydrilate
  • mydrilate
  • penolair
  • pentolair
  • pentolair
  • α-(1-hydroxycyclopentyl)benzeneacetic acid 2-(dimethylamino)ethyl ester
  • α-(1-hydroxycyclopentyl)benzeneacetic acid 2-(dimethylamino)ethyl ester
  • β-dimethylaminoethyl (1-hydroxycyclopentyl)phenylacetate
  • β-dimethylaminoethyl (1-hydroxycyclopentyl)phenylacetate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06077682Phase 4Sep 1, 2023Hamad Medical Corporation, Islamic Hospital, Amman, Jordan, Jordan University, Yarmouk University
NCT05442801Phase 4Mar 1, 2022Islamic Hospital, Amman, Jordan, Yarmouk University
NCT05204069N/AJan 1, 2021Assistance Publique - Hôpitaux de Paris
NCT05614622N/ANov 10, 2020Tel Aviv University
NCT03851172Phase 2Mar 1, 2019Assiut University
NCT03638726Phase 4Sep 28, 2018Dar El Oyoun Hospital
NCT02909140N/ADec 1, 2016Johns Hopkins University
NCT02717871Phase 3Mar 1, 2016University of Geneva
NCT02409641N/AFeb 1, 2015University of Vienna
NCT02177539Phase 4May 1, 2014Pontificia Universidad Catolica de Chile
NCT04838665Phase 4Sep 30, 2011University of the Philippines
NCT01054027N/AMar 1, 2007Georgetown University
NCT00348166Phase 1Dec 1, 2005KK Women's and Children's Hospital, Singapore National Eye Centre
Showing 13 of 13 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Islamic Hospital, Amman, JordanAcademic/Hospital2212022
Yarmouk UniversityAcademic/Hospital2012022
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112021
Assiut UniversityAcademic/Hospital1112019
Dar El Oyoun HospitalAcademic/Hospital1112018
Georgetown UniversityAcademic/Hospital1112007
Hamad Medical CorporationFor profit1012023
Johns Hopkins UniversityAcademic/Hospital1112016
Jordan UniversityAcademic/Hospital1012023
KK Women's and Children's HospitalAcademic/Hospital1112005
Pontificia Universidad Catolica de ChileAcademic/Hospital1112014
Singapore National Eye CentreAcademic/Hospital1012005
Tel Aviv UniversityAcademic/Hospital1112020
University of GenevaAcademic/Hospital1112016
University of the PhilippinesAcademic/Hospital1112011
University of ViennaAcademic/Hospital1112015
16 organizations
Page 1 / 1

Marketing (13)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitSYNJan 13, 1997
Akorn, Inc.For profitMKTGDec 9, 2015
AlconFor profitMKTGJul 31, 1974
AlconFor profitSYNJan 24, 1991
AlconFor profitNDAJul 31, 1974
Bausch & LombFor profitMKTGApr 29, 1994
Epic Pharma LlcFor profitMKTGApr 10, 1979
Johnson and JohnsonFor profitMKTGNov 22, 1974
NestleFor profitMKTGJan 24, 1991
PharmafairFor profitMKTG—
Rising PharmaceuticalsFor profitMKTGJan 13, 1997
Saptalis PharmaceuticalsFor profitMKTGDec 9, 2015
Sciegen PharmaceticalsFor profitMKTGDec 9, 2015