Eszopiclone
As of the edition of 20 October 2026, Eszopiclone is a small molecule: marketed, first approved in 2004 (US); acts on GABRA1, GABRA2 and GABRA3 and 4 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Lunesta
- First approved
- 15 December 2004 (US)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- G.L. PHARMA (AUTRICHE); 4 holders in all
- Registered trials
- 52, 4 stopped early
- Disease areas
- Nervous system; Mental health; Lungs and airways; Bones, joints and muscles; Nutrition and metabolism; Chemically induced
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.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| GABRA1 | Gamma-aminobutyric acid receptor subunit alpha-1 | P14867 |
| GABRG2 | Gamma-aminobutyric acid receptor subunit gamma-2 | P18507 |
| GABRA5 | Gamma-aminobutyric acid receptor subunit alpha-5 | P31644 |
| GABRA3 | Gamma-aminobutyric acid receptor subunit alpha-3 | P34903 |
| GABRA2 | Gamma-aminobutyric acid receptor subunit alpha-2 | P47869 |
| GABRG1 | Gamma-aminobutyric acid receptor subunit gamma-1 | Q8N1C3 |
| GABRG3 | Gamma-aminobutyric acid receptor subunit gamma-3 | Q99928 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 11 | 0 | 0 |
| Phase 1 | 6 | 5 | 0 | 1 |
| Phase 2 | 5 | 3 | 2 | 0 |
| Phase 3 | 15 | 14 | 1 | 0 |
| Phase 4 | 15 | 11 | 0 | 3 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eisai | Applicant and Lead sponsor of trials | 2008 to now |
| Eurofarma Laboratorios | Applicant and Lead sponsor of trials | 2011 to now |
| Waylis Therapeutics | Acquired holder | 2024 to now |