Drugs / tropicamide

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) MYDRIACYL 1960-02-23 fda.gov

Trials 17 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06288321 Aug 2022 → Mar 2023 retinopathy of prematurity The University of Hong Kong Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07075224 Nov 2025 Unither Pharmaceuticals, France Completed No outcome recorded
Phase 23 trials
Phase 2 NCT03201562 Apr 2017 → May 2018 presbyopia LENZ Therapeutics, Inc Completed No outcome recorded
Phase 2 NCT01844648 Apr 2013 → Oct 2015 NeuroHealing Pharmaceuticals Inc. Completed No outcome recorded
Phase 2 NCT00761137 Mar 2008 → Jun 2010 secondary Parkinson disease NeuroHealing Pharmaceuticals Inc. Completed No outcome recorded
Phase 31 trial
Phase 3 NCT03751631 Nov 2018 → Jan 2019 Eyenovia Inc. Completed No outcome recorded
Phase 49 trials
Phase 4 NCT06366217 Sep → Dec 2024 overdue abnormal pupillary function University of California, San Francisco Not yet recruiting No outcome recorded
Phase 4 NCT06217796 Nov 2023 → Jan 2024 Eyenovia Inc. Completed No outcome recorded
Phase 4 NCT05238233 Apr 2022 → Jan 2023 anisocoria Prisma Health-Upstate Completed No outcome recorded
Phase 4 NCT05043077 Sep 2021 → Jan 2023 retinopathy of prematurity Aristotle University Of Thessaloniki Completed No outcome recorded
Phase 4 NCT04907474 May → Jun 2021 Eyenovia Inc. Completed No outcome recorded
Phase 4 NCT04623684 Mar → Sep 2020 retinopathy of prematurity Aristotle University Of Thessaloniki Completed No outcome recorded
Phase 4 NCT02177539 May → Aug 2014 refractive error Pontificia Universidad Catolica de Chile Unknown No outcome recorded
Phase 4 NCT04838665 Sep 2011 retinopathy of prematurity University of the Philippines Completed No outcome recorded
Phase 4 NCT00877175 Mar → May 2009 Khon Kaen University Completed No outcome recorded
Phase not applicable2 trials
NCT06914063 Mar → Jun 2025 overdue cycloplegia Superior University Active not recruiting No outcome recorded
NCT07495670 Nov 2024 → Jan 2025 diabetes mellitus, diabetic retinopathy Burapha University Completed No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03139708 Background Sep 2016 → Oct 2017 Wake Forest University Health Sciences Completed No outcome recorded
Phase 35 trials
Phase 3 NCT04932213 Comparator Jul → Nov 2021 type 1 diabetes mellitus, type 2 diabetes mellitus Semnan University of Medical Sciences Completed No outcome recorded
Phase 3 NCT04396301 Comparator Feb → Aug 2019 cataract, corneal disorder Cairo University Completed No outcome recorded
Phase 3 NCT02101359 Comparator Jun 2011 → Jan 2013 cataract Laboratoires Thea Completed No outcome recorded
Phase 3 NCT00642135 Comparator Jan 2006 → Feb 2008 Assistance Publique - Hôpitaux de Paris Terminated No outcome recorded
Phase 3 NCT00120432 Comparator Dec 2004 → Jun 2005 eye disorder Khon Kaen University Completed No outcome recorded
Phase 47 trials
Phase 4 NCT06077682 Comparator Sep 2023 → Sep 2024 cycloplegia, esotropia, refractive error, vision disorder Islamic Hospital, Jordan Unknown No outcome recorded
Phase 4 NCT05442801 Comparator Mar → Jun 2022 cycloplegia Islamic Hospital, Jordan Completed No outcome recorded
Phase 4 NCT05771194 Background Feb 2021 → Mar 2022 eyelid disorder Tianjin Medical University Eye Hospital Completed No outcome recorded
Phase 4 NCT04880928 Comparator Aug 2020 → Sep 2021 cataract Medical University of Graz Completed No outcome recorded
Phase 4 NCT03959176 Background Jul 2019 ocular hypertension Wake Forest University Health Sciences Completed No outcome recorded
Phase not applicable2 trials
NCT04040790 Background Sep 2019 → Jun 2021 vision disorder University Ghent Terminated No outcome recorded
NCT02895074 Background Aug 2014 → Jun 2015 cataract Sun Yat-sen University Completed No outcome recorded

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 34 sources stand behind the page.

FieldValueCited text
Known as tropicamide “The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide...” NCT04396301
31

“standard Mydrin-P (0.5% tropicamide / 0.5% phenylephrine HCl) which is the standard eyedrops used for dilation of pupil before retinopathy of prematurity examination.” NCT06288321

“Rapid-Onset Cycloplegic Drops (e.g., tropicamide with phenylephrine) to assess patient comfort, anxiety, and satisfaction with quicker onset and shorter duration.” NCT06914063

“Fixed combination of 0.34 % tropicamide and 2.5 % phenylephrine Hydrochloride (HCl) Eye drop Solution.” NCT07075224

“The compound tropicamide was administered once a day (Shentian Pharmaceutical Co., Ltd., China)” NCT05771194

“3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery.” NCT02101359

tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%” NCT06217796

Tropicamide and Phenylephrine ophthalmic one drop” NCT03139708

Tropicamide 1% and phenylephrine HCl 2.5%” NCT06366217

Tropicamide 0.5%” NCT04880928

NCT02895074

NCT04838665

NCT04907474

NCT05442801

NCT02373137

NCT05238233

NCT03201562

NCT01844648

NCT00877175

NCT04040790

NCT03751631

NCT00642135

NCT02177539

NCT07495670

NCT06077682

NCT05043077

NCT04932213

NCT03959176

NCT00120432

NCT04623684

NCT00761137

NCT00541177

Known as Bistropamide ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Mydriacyl ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Mydriafair ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as NH004 “Drug: NH004 tropicamide” NCT01844648
Known as Nods ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as NSC-757372 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as RO-1-7683 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Tropicacyl ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Tropicamid “eye drops (Tropicamid)” NCT04880928
Known as Tropicamida ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Tropicamide component of mydcombi ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Tropicamide component of paremyd ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Tropicamidum ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Known as Visumidriatic ChEMBL registry synonym — accepted as the source's own label CHEMBL1200604
Action Inhibit “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1200604
1

“tropicamide (muscarinic antagonist)” NCT07495670

Modality Small molecule CHEMBL1200604
Route Topical “Group A received a single dose of 1% tropicamide and 10% phenylephrine eye drops, and Group B received three doses of the same drugs.” PMID 17205877 Nov 2006
Target CHRM3 “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1200604