Overview

A parasympatholytic anticholinergic used solely to obtain mydriasis or cycloplegia.

Indication

Used mainly to produce mydriasis and cycloplegia for diagnostic purposes.

Associated Conditions

Anterior Uveitis (AU)

Research Report

Published: Sep 30, 2025

A Comprehensive Monograph on Cyclopentolate: Pharmacology, Clinical Utility, and Safety Profile

Executive Summary

Cyclopentolate is a synthetic, small-molecule muscarinic antagonist widely utilized in ophthalmology for its potent mydriatic (pupil-dilating) and cycloplegic (accommodation-paralyzing) properties. With a DrugBank Accession Number of DB00979 and a CAS Registry Number of 512-15-2, it serves as an indispensable tool for diagnostic procedures, particularly cycloplegic refraction in pediatric populations, and for certain therapeutic applications such as the management of anterior uveitis. Its mechanism of action involves the competitive blockade of acetylcholine at muscarinic receptors on the iris sphincter and ciliary body muscles, leading to rapid and intense, yet reversible, ocular effects.

Pharmacokinetically, cyclopentolate is characterized by a rapid onset of action, with peak effects occurring within 15 to 75 minutes, and a duration that typically lasts up to 24 hours. This profile positions it as a favorable alternative to the longer-acting atropine and a more reliable cycloplegic agent than the shorter-acting tropicamide. However, its clinical utility is intrinsically linked to a significant safety consideration: the potential for systemic absorption and subsequent anticholinergic toxicity. The drug's chemical structure—a moderately lipophilic tertiary amine—facilitates not only its intended penetration through the cornea but also its unintended entry into the systemic circulation and across the blood-brain barrier.

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Cycloplegic Refraction in Pediatric Patients With Esotropia	2023/10/11	NCT06077682	Phase 4	Recruiting	Islamic Hospital, Jordan
Mydriatic Drops After Combined Surgery	2022/11/14	NCT05614622	Not Applicable	Completed	Rabin Medical Center
Cycloplegic Refraction Among Children	2022/07/05	NCT05442801	Phase 4	Completed	Islamic Hospital, Jordan
Screening for 3-D Visual Disorders in Preschool Children	2022/01/24	NCT05204069	Not Applicable	Completed	Assistance Publique - Hôpitaux de Paris
Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study	2021/04/09	NCT04838665	Phase 4	Completed	University of the Philippines
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery	2019/02/22	NCT03851172	Phase 2	UNKNOWN	Assiut University
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification	2018/08/20	NCT03638726	Phase 4	UNKNOWN	Dar El Oyoun Hospital
Evaluation of a Protocol of Pupil Dilation Before Laser-assisted Cataract Surgery	2017/12/18	NCT03375996	N/A	Completed	CHU de Reims
Optimal Method for Mydriasis in Cataract Surgery	2016/09/21	NCT02909140	Not Applicable	Terminated	Johns Hopkins University
A New More Efficient Cycloplegia Scheme	2014/06/27	NCT02177539	Phase 4	UNKNOWN	Pontificia Universidad Catolica de Chile

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cyclopentolate	Akorn	17478-096	OPHTHALMIC	5 mg in 1 mL	1/25/2022
Cyclogyl	Alcon Laboratories, Inc.	0065-0397	OPHTHALMIC	20 mg in 1 mL	12/14/2023
Cyclopentolate Hydrochloride	Physicians Total Care, Inc.	54868-4697	OPHTHALMIC	10 mg in 1 mL	2/6/2013
AK-PENTOLATE	Rebel Distributors Corp.	21695-883	OPHTHALMIC	10 mg in 1 mL	3/9/2009
Cyclopentolate Hydrochloride	A-S Medication Solutions	50090-3234	OPHTHALMIC	10 mg in 1 mL	8/24/2016
Cyclopentolate Hydrochloride	Rebel Distributors Corp	42254-013	OPHTHALMIC	10 mg in 1 mL	5/12/2010
Cyclomydril	Alcon Laboratories, Inc.	0065-0359	OPHTHALMIC	2 mg in 1 mL	12/14/2023
Cyclogyl	Alcon Laboratories, Inc.	0065-0395	OPHTHALMIC	5 mg in 1 mL	12/14/2023
Cyclogyl	Alcon Laboratories, Inc.	0065-0396	OPHTHALMIC	10 mg in 1 mL	12/14/2023
Cyclopentolate Hydrochloride	A-S Medication Solutions	50090-3874	OPHTHALMIC	10 mg in 1 mL	9/30/2011

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MINIMS CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS 1% w/v	LABORATOIRE CHAUVIN SA	SIN04201P	SOLUTION	1% w/v	4/16/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CYCLOGYL cyclopentolate hydrochloride 1% eye drops bottle	25273	Alcon Laboratories Australia Pty Ltd	Medicine	A	10/15/1991
Minims Cyclopentolate Hydrochloride 1% 10mg/mL eye drops tube	32267	Bausch & Lomb Australia Pty Ltd	Medicine	A	10/30/1991
MINIMS CYCLOPENTOLATE HYDROCHLORIDE 0.5% 5mg/ml eye drops tube	32265	Bausch & Lomb Australia Pty Ltd	Medicine	A	10/30/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ODAN-CYCLOPENTOLATE	odan laboratories ltd	00626635	Solution - Ophthalmic	0.5 %	12/31/1984
MINIMS CYCLOPENTOLATE HYDROCHLORIDE	bausch & lomb inc	02148331	Solution - Ophthalmic	0.5 % / W/V	12/31/1995
CYCLOPENTOLATE	pharma stulln inc.	02023687	Solution - Ophthalmic	0.5 %	12/31/1994
CYCLOGYL	Alcon Canada Inc	00252506	Drops - Ophthalmic	1 % / W/V	12/31/1972
ODAN-CYCLOPENTOLATE	odan laboratories ltd	00626627	Solution - Ophthalmic	1 %	12/31/1984
MINIMS CYCLOPENTOLATE HYDROCHLORIDE	bausch & lomb inc	02148382	Solution - Ophthalmic	1 % / W/V	12/31/1995
CYCLOPENTOLATE	pharma stulln inc.	02023644	Solution - Ophthalmic	1 %	12/31/1994
PMS-CYCLOPENTOLATE HCL OPH SOLUTION 1%	Pharmascience Inc	00878189	Liquid - Ophthalmic	1 %	12/31/1992
DOM-CYCLOPENTOLATE HCL OPHTHALMIC SOLUTION-1%	dominion pharmacal	02181436	Solution - Ophthalmic	1 %	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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