Approval Probability
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Lexapro · 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...
Lexapro is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated in bioavailability studies comparing escitalopram oxalate tablets to Lexapro tablets. These studies are not intended to treat any disease but to assess the drug's pharmacokinetic profile in healthy subjects.
Lexapro is a small molecule drug. The specific molecular target of Lexapro is not disclosed in the available information. The drug is being studied in healthy volunteers to evaluate its pharmacokinetic properties, including absorption and bioavailability, rather than its mechanism of action in treating a disease.
Lexapro is being developed by Viatris Inc., a pharmaceutical company listed on the stock exchange under the ticker symbol VTRS. Viatris is conducting Phase 1 clinical trials to evaluate the drug's bioavailability in healthy volunteers. The company is responsible for the clinical development and regulatory strategy for Lexapro.
Lexapro is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trials are designed to assess the drug's pharmacokinetics, including how it is absorbed and processed by the body, in healthy volunteers. These studies are ongoing or completed as part of early-stage development.
Lexapro has been studied in two Phase 1 clinical trials. The first trial, NCT00648570, is a fasting study comparing escitalopram oxalate tablets 20 mg to Lexapro tablets 20 mg, with 37 participants. The second trial, NCT00648661, is a food study with 35 participants. Both trials were completed in the United States and enrolled healthy volunteers aged 18 years and older.
Lexapro is being studied as a reference product in clinical trials comparing it to escitalopram oxalate tablets. The trials are designed to evaluate the bioequivalence of the generic escitalopram oxalate formulation to the branded Lexapro tablets. Lexapro is the brand name for escitalopram, and the studies aim to confirm that the generic version delivers the same amount of drug to the body.