tropicamide
Trade name: mydriacyl
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
Earliest trial started Dec 1, 2004 (NCT00120432)
Timeline
1980s
- Jul 30, 1982
Miza Pharmaceuticals — Marketing Organization
- Aug 28, 1985
Akorn, Inc. — Marketing Organization
1990s
- Dec 28, 1990
Alcon — Marketing Organization
- Dec 28, 1990
Nestle — Marketing Organization
- Jan 30, 1992
Akorn, Inc. — NDA Secondary Org
- Jan 30, 1992
Epic Pharma Llc — NDA Secondary Org
- Jul 27, 1994
Bausch & Lomb — Marketing Organization
2000s
- Sep 29, 2000
Rising Pharmaceuticals — Marketing Organization
- Jan 1, 2004
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2016
Earliest Phase 1 Sponsor(trial)
- Dec 12, 2019
Somerset Pharmaceuticals — Marketing Organization
- Dec 12, 2019
Mylan — Marketing Organization
2020s
- May 5, 2023
Eyenovia Inc. — NDA Secondary Org
Indications
Approved for
Studied for
- Anisocoria · Phase 4
- Cataract · Phase 4
- Corneal Endothelial Cell Loss · Phase 3
- Corneal Transplantation · Phase 4
- Diabetes Mellitus, Type 1 · Phase 3
- Diabetes Mellitus, Type 2 · Phase 3
- Esotropia · Phase 4
- Eye Diseases · Phase 4
- Infant, Premature · Phase 4
- Intraocular Pressure · Phase 4
- Mydriasis · Phase 4
- Myopia · Phase 4
- Parkinson Disease · Phase 2
- Premature Birth · Phase 3
- Refractive Errors · Phase 4
- Retinal Diseases · Phase 3
- Retinopathy of Prematurity · Phase 4
- Sialorrhea · Phase 2
- Vision Disorders · Phase 4
Mechanism of action
- Muscarinic acetylcholine receptor M3ANTAGONIST
CHRM3 antagonist
Indicated for mydriasis, M3 likely involved (main form in iris)
Combination products
mydcombi
with phenylephrine
Also known as eye injection (mydrane)
paremy
with hydroxyamphetamine
Approval history
- approvedFeb 23, 1960
Chemistry & pharmacology
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
- WikipediaTropicamide ↗
- NCATSN0A3Z5XTC6 ↗
- ChEMBLCHEMBL1200604 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07075224 | Phase 1/Phase 2 (Phase 2) | Jul 15, 2025 | Unither Pharmaceuticals |
| NCT06077682 | Phase 4 | Sep 1, 2023 | Hamad Medical Corporation, Islamic Hospital, Amman, Jordan, Jordan University, Yarmouk University |
| NCT05566626 | N/A | Oct 31, 2022 | Mantis Photonics AB |
| NCT05238233 | Phase 4 | Apr 1, 2022 | Prisma Health |
| NCT05442801 | Phase 4 | Mar 1, 2022 | Islamic Hospital, Amman, Jordan, Yarmouk University |
| NCT05043077 | Phase 4 | Sep 7, 2021 | Aristotle University of Thessaloniki, University of Athens |
| NCT04932213 | Phase 3 | Jul 7, 2021 | Semnan University of Medical Sciences, University of Tehran |
| NCT04907474 | Phase 4 | May 24, 2021 | Eyenovia Inc. |
| NCT04880928 | Phase 4 | Aug 12, 2020 | Medical University of Graz |
| NCT04623684 | Phase 4 | Mar 24, 2020 | Aristotle University of Thessaloniki |
| NCT03959176 | Phase 4 | Jul 31, 2019 | Wake Forest University |
| NCT04040790 | N/A | Jul 31, 2019 | Ghent University |
| NCT04396301 | Phase 3 | Feb 1, 2019 | Cairo University |
| NCT03751098 | Phase 3 | Dec 1, 2018 | Eyenovia Inc. |
| NCT03751631 | Phase 3 | Nov 15, 2018 | Eyenovia Inc. |
| NCT03097198 | N/A | Dec 1, 2016 | Wenzhou Medical University |
| NCT03139708 | Phase 1 | Sep 1, 2016 | Wake Forest University |
| NCT02373137 | Phase 4 | Jan 1, 2015 | Oregon Health and Science University, Stanford University, University of California, San Francisco |
| NCT02895074 | N/A | Aug 1, 2014 | Government of China, Sun Yat-Sen University |
| NCT02177539 | Phase 4 | May 1, 2014 | Pontificia Universidad Catolica de Chile |
Organizations
Research & Development (33)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eyenovia Inc. | For profit | 3 | 3 | 2 | 2018 |
| Aristotle University of Thessaloniki | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Islamic Hospital, Amman, Jordan | Academic/Hospital | 2 | 2 | 1 | 2022 |
| KhonKaen University | Academic/Hospital | 2 | 2 | 2 | 2004 |
| Michael J. Fox Foundation for Parkinson's Research | Academic/Hospital | 2 | 0 | 1 | 2008 |
| NeuroHealing Pharmaceuticals Inc. | For profit | 2 | 2 | 1 | 2008 |
| Wake Forest University | Academic/Hospital | 2 | 2 | 2 | 2016 |
| Yarmouk University | Academic/Hospital | 2 | 0 | 1 | 2022 |
| Cairo University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Ghent University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Government of China | Government | 1 | 0 | 1 | 2014 |
| Hamad Medical Corporation | For profit | 1 | 0 | 1 | 2023 |
| Ioltech | For profit | 1 | 0 | 1 | 2006 |
| Jordan University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Laboratoires Thea | For profit | 1 | 1 | 1 | 2011 |
| Mantis Photonics AB | For profit | 1 | 1 | 1 | 2022 |
| Medical University of Graz | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Min-Sheng General Hospital | Academic/Hospital | 1 | 1 | 1 | 2007 |
| National Yang-Ming University | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Oregon Health and Science University | Academic/Hospital | 1 | 1 | 1 | 2015 |
Marketing (18)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Akorn, Inc. | For profit | MKTG | Aug 28, 1985 |
| Akorn, Inc. | For profit | NDA2 | Jan 30, 1992 |
| Alcon | For profit | MKTG | Dec 28, 1990 |
| Alcon | For profit | NDA | Feb 23, 1960 |
| Alcon | For profit | SYN | Dec 6, 1974 |
| Bausch & Lomb | For profit | MKTG | Jul 27, 1994 |
| Epic Pharma Llc | For profit | NDA2 | Jan 30, 1992 |
| Eyenovia Inc. | For profit | NDA2 | May 5, 2023 |
| Miza Pharmaceuticals | For profit | MKTG | Jul 30, 1982 |
| Mylan | For profit | MKTG | Dec 12, 2019 |
| Nestle | For profit | MKTG | Dec 28, 1990 |
| Novartis | For profit | MKTG | Dec 6, 1974 |
| Pharmafair | For profit | MKTG | — |
| Rising Pharmaceuticals | For profit | MKTG | Sep 29, 2000 |
| Sandoz | For profit | MKTG | Dec 6, 1974 |
| Sandoz | For profit | SYN | Dec 6, 1974 |
| Somerset Pharmaceuticals | For profit | MKTG | Dec 12, 2019 |
| Watson Pharmaceuticals | For profit | MKTG | — |