Glimepiride
As of the edition of 20 October 2026, Glimepiride is a small molecule: marketed, first approved in 1995 (US); acts on ABCC8 and KCNJ11; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Amaryl
- First approved
- 30 November 1995 (US)
- Approvals on record
- 15 in 5 regions
- Holder of the most recent approval
- Takeda; 5 holders in all
- Registered trials
- 107, 7 stopped early
- Disease areas
- Hormones; Nutrition and metabolism; Heart and blood vessels; Chemically induced; Mental health; Pregnancy and women's health
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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Glimepiride.
See the 3 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 not stated | 18 | 14 | 2 | 0 |
| Phase 1 | 18 | 18 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 43 | 36 | 1 | 6 |
| Phase 4 | 27 | 22 | 0 | 1 |
| All trials | 107 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 1995 to now |
| Takeda | Applicant and Lead sponsor of trials | 2006 to now |
| Cheplapharm Arzneimittel | Applicant | 2007 to now |