Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eszopiclone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Eszopiclone Tablets | EXPERIMENTAL | Eszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited |
| Lunesta | ACTIVE_COMPARATOR | Lunesta Tablets 3 mg of Sepracor Inc. |
| Name | Type | Description |
|---|---|---|
| Eszopiclone Tablets 3 mg | DRUG | - |
Inclusion Criteria: 1. The subjects should be healthy human between 18 and 45 years. 2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug. 3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter. 4. The subjects...
Eszopiclone is a small molecule drug developed by Dr. Reddy's Laboratories Ltd under the ticker RDY. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed. Eszopiclone Tablets 3 mg is the name used for the formulation evaluated in the company's clinical studies.
Eszopiclone targets GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. It acts as a positive allosteric modulator within the GABA receptor target class. This mechanism involves modulating these receptor subunits rather than directly activating them, which is characteristic of positive allosteric modulator compounds.
Eszopiclone is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is running the clinical development program for Eszopiclone Tablets 3 mg. Dr. Reddy's Laboratories is the sponsor of the registered Phase 1 bioequivalence studies for this drug.
Eszopiclone is in Phase 1 clinical development. Both registered trials for Eszopiclone Tablets 3 mg are Phase 1 bioequivalence studies, and both have been completed. There are no active trials currently listed for this program, and the drug is investigational rather than approved.
Eszopiclone has been evaluated in two completed Phase 1 bioequivalence trials. NCT02322658 studied Eszopiclone Tablets 3 mg under fed conditions, and NCT02322645 studied the same tablets under fasting conditions. Both trials enrolled 46 healthy volunteers in India, for a total enrollment of 92 participants, and both used an active-controlled, randomized design.