tropicamide

Trade name: mydriacyl

Small moleculeapproved

Approved

Feb 23, 1960

Tropicamide (Mydriacyl) is an anticholinergic used as a mydriatic.Tropicamide belongs to the group of medicines called anti-muscarinics. Tropicamide blocks the receptors in the muscles of the eye (muscarinic receptors). These receptors are involved controlling the pupil size and the shape of the lens. By blocking these receptors, tropicamide produces dilatation of the pupil (mydriasis) and prevents the eye from accommodating for near vision (cycloplegia). Tropicamide is given as eye drops to dilate the pupil and relax the lens so that eye examinations can be carried out thoroughly. — NCATS

Clinical trial activity

28 trials · 33 clinical orgs · 14 marketing orgs

Phase 1
2
Phase 2
10
Phase 3
7
Phase 4
13

Earliest trial started Dec 1, 2004 (NCT00120432)

Timeline

1960s

  1. Feb 23, 1960

    Alcon — Earliest FDA Approval

  2. Feb 23, 1960

    Alcon — NDA Organization

1970s

  1. Dec 6, 1974

    Novartis — Marketing Organization

  2. Dec 6, 1974

    Sandoz — Marketing Organization

1980s

  1. Jul 30, 1982

    Miza Pharmaceuticals — Marketing Organization

  2. Aug 28, 1985

    Akorn, Inc. — Marketing Organization

1990s

  1. Dec 28, 1990

    Alcon — Marketing Organization

  2. Dec 28, 1990

    Nestle — Marketing Organization

  3. Jan 30, 1992

    Akorn, Inc. — NDA Secondary Org

  4. Jan 30, 1992

    Epic Pharma Llc — NDA Secondary Org

  5. Jul 27, 1994

    Bausch & Lomb — Marketing Organization

2000s

  1. Sep 29, 2000

    Rising Pharmaceuticals — Marketing Organization

  2. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

  2. Dec 12, 2019

    Somerset Pharmaceuticals — Marketing Organization

  3. Dec 12, 2019

    Mylan — Marketing Organization

2020s

  1. May 5, 2023

    Eyenovia Inc. — NDA Secondary Org

Indications

Mechanism of action

Combination products

Approval history

  • approvedFeb 23, 1960

Chemistry & pharmacology

Loading structure…

SMILES

CCN(CC1=CC=NC=C1)C(=O)C(CO)C2=CC=CC=C2
Mol. weight
284.3529 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

  • bistropamide
  • epitromina
  • mydriacyl
  • mydriacyl
  • mydriacyl
  • mydriacyl
  • mydriafair
  • mydriafair
  • nods
  • tropicacyl
  • tropicacyl
  • tropicamid
  • tropicamid
  • tropicamida
  • tropicamida
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamide
  • tropicamidum
  • tropicamidum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07075224Phase 1/Phase 2 (Phase 2)Jul 15, 2025Unither Pharmaceuticals
NCT06077682Phase 4Sep 1, 2023Hamad Medical Corporation, Islamic Hospital, Amman, Jordan, Jordan University, Yarmouk University
NCT05566626N/AOct 31, 2022Mantis Photonics AB
NCT05238233Phase 4Apr 1, 2022Prisma Health
NCT05442801Phase 4Mar 1, 2022Islamic Hospital, Amman, Jordan, Yarmouk University
NCT05043077Phase 4Sep 7, 2021Aristotle University of Thessaloniki, University of Athens
NCT04932213Phase 3Jul 7, 2021Semnan University of Medical Sciences, University of Tehran
NCT04907474Phase 4May 24, 2021Eyenovia Inc.
NCT04880928Phase 4Aug 12, 2020Medical University of Graz
NCT04623684Phase 4Mar 24, 2020Aristotle University of Thessaloniki
NCT03959176Phase 4Jul 31, 2019Wake Forest University
NCT04040790N/AJul 31, 2019Ghent University
NCT04396301Phase 3Feb 1, 2019Cairo University
NCT03751098Phase 3Dec 1, 2018Eyenovia Inc.
NCT03751631Phase 3Nov 15, 2018Eyenovia Inc.
NCT03097198N/ADec 1, 2016Wenzhou Medical University
NCT03139708Phase 1Sep 1, 2016Wake Forest University
NCT02373137Phase 4Jan 1, 2015Oregon Health and Science University, Stanford University, University of California, San Francisco
NCT02895074N/AAug 1, 2014Government of China, Sun Yat-Sen University
NCT02177539Phase 4May 1, 2014Pontificia Universidad Catolica de Chile
Showing 20 of 28 trials
Page 1 / 2

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Eyenovia Inc.For profit3322018
Aristotle University of ThessalonikiAcademic/Hospital2212020
Islamic Hospital, Amman, JordanAcademic/Hospital2212022
KhonKaen UniversityAcademic/Hospital2222004
Michael J. Fox Foundation for Parkinson's ResearchAcademic/Hospital2012008
NeuroHealing Pharmaceuticals Inc.For profit2212008
Wake Forest UniversityAcademic/Hospital2222016
Yarmouk UniversityAcademic/Hospital2012022
Cairo UniversityAcademic/Hospital1112019
Ghent UniversityAcademic/Hospital1112019
Government of ChinaGovernment1012014
Hamad Medical CorporationFor profit1012023
IoltechFor profit1012006
Jordan UniversityAcademic/Hospital1012023
Laboratoires TheaFor profit1112011
Mantis Photonics ABFor profit1112022
Medical University of GrazAcademic/Hospital1112020
Min-Sheng General HospitalAcademic/Hospital1112007
National Yang-Ming UniversityAcademic/Hospital1012007
Oregon Health and Science UniversityAcademic/Hospital1112015
33 organizations
Page 1 / 2

Marketing (18)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGAug 28, 1985
Akorn, Inc.For profitNDA2Jan 30, 1992
AlconFor profitMKTGDec 28, 1990
AlconFor profitNDAFeb 23, 1960
AlconFor profitSYNDec 6, 1974
Bausch & LombFor profitMKTGJul 27, 1994
Epic Pharma LlcFor profitNDA2Jan 30, 1992
Eyenovia Inc.For profitNDA2May 5, 2023
Miza PharmaceuticalsFor profitMKTGJul 30, 1982
MylanFor profitMKTGDec 12, 2019
NestleFor profitMKTGDec 28, 1990
NovartisFor profitMKTGDec 6, 1974
PharmafairFor profitMKTG
Rising PharmaceuticalsFor profitMKTGSep 29, 2000
SandozFor profitMKTGDec 6, 1974
SandozFor profitSYNDec 6, 1974
Somerset PharmaceuticalsFor profitMKTGDec 12, 2019
Watson PharmaceuticalsFor profitMKTG