Apraclonidine
As of the edition of 20 October 2026, Apraclonidine is a small molecule: marketed, first approved in 1987 (US); acts on ADRA2A, ADRA2B and ADRA2C; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Iopidine
- First approved
- 31 December 1987 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Essential Pharma; 3 holders in all
- Registered trials
- 5, 1 stopped early
- Disease areas
- Nervous system; Cancer; Immune system; Infections; Mouth and teeth
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Apraclonidine.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 3 | 1 | 2 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Originator and Lead sponsor of trials | 1987 to now |
| Harrow Eye | Acquired holder | 2023 to now |