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Label indication Lexapro is indicated for the treatment of: • major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. • generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older. FDA label
Escitalopram Oxalate · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Escitalopram Oxalate Tablets 20 mg |
| 2 | ACTIVE_COMPARATOR | Lexapro® Tablets 20 mg |
| Name | Type | Description |
|---|---|---|
| Escitalopram Oxalate Tablets 20 mg | DRUG | 20mg, single dose fed |
| Lexapro® Tablets 20 mg | DRUG | 20mg, single dose fed |
| Lexapro® Tablets (20 mg | DRUG | 20mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum β-human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening p...
Escitalopram Oxalate is a small molecule drug developed by Viatris Inc. (VTRS). It is being studied in Phase 1 clinical trials, with two completed trials in healthy volunteers. The trials evaluated the bioavailability of Escitalopram Oxalate Tablets 20 mg compared to Lexapro Tablets 20 mg under fed and fasting conditions.
Escitalopram Oxalate targets SLC6A4, also known as the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 is involved in regulating serotonin levels in the brain, and inhibition of this transporter is a known mechanism for certain central nervous system effects.
Escitalopram Oxalate is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.
Escitalopram Oxalate is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication based on the available information.
Escitalopram Oxalate has been studied in two completed Phase 1 trials: NCT00648661, a food study comparing Escitalopram Oxalate Tablets 20 mg to Lexapro Tablets 20 mg in 35 healthy volunteers, and NCT00648570, a fasting study comparing the same products in 37 healthy volunteers. Both trials were conducted in the United States.