Cyclopentolate
As of the edition of 20 October 2026, Cyclopentolate is a small molecule: marketed, first approved in 1965 (ES); acts on CHRM3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1988
- Kind
- Small molecule
- Brand name
- Colirofta Ciclopléjico
- First approved
- 1 November 1965 (ES)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Bausch Health; 3 holders in all
- Registered trials
- 11, 2 stopped early
- Disease areas
- Eye; Inherited and neonatal; Chemically induced; Nervous system; Pregnancy and women's health; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CHRM3 | Muscarinic acetylcholine receptor M3 | P20309 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 5 | 0 | 1 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 1 | 0 | 0 | 0 |
| Phase 4 | 3 | 1 | 0 | 0 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Applicant | 1972 to now |
| Bausch Health | Later holder | 1995 to now |