Gliclazide
As of the edition of 20 October 2026, Gliclazide is a small molecule: marketed, first approved in 2000 (CA); acts on ABCC8 and KCNJ11.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Diamicron Mr
- First approved
- 24 November 2000 (CA)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Servier; 2 holders in all
- Registered trials
- 20, 3 stopped early
- Disease areas
- Hormones; Nutrition and metabolism; Mental health; Heart and blood vessels; Nervous system
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 1 | 0 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 3 | 3 | 2 | 0 | 1 |
| Phase 4 | 8 | 6 | 0 | 2 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Servier | Applicant and Lead sponsor of trials | 2000 to now |