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Lexapro (escitalopram)
Inhibits CNS neuronal reuptake of serotonin (5-HT), potentiating serotonergic activity.
Escitalopram is an SSRI indicated for major depressive disorder in adults and pediatric patients 12 years and older, and generalized anxiety disorder in adults. It selectively inhibits serotonin reuptake with minimal effects on other neurotransmitter systems, achieving steady-state concentrations within one week. Major risks include serotonin syndrome with concurrent serotonergic drugs or MAOIs, QT prolongation with pimozide, and increased bleeding with anticoagulants. Linear pharmacokinetics with approximately 80% bioavailability support once-daily dosing regimens.
At a glance
| Generic name | escitalopram |
|---|---|
| Also known as | Lexapro, Cipralex |
| Sponsor | Generic (originally Lundbeck/Forest) |
| Drug class | Selective Serotonin Reuptake Inhibitor (SSRI) |
| Target | Serotonin (5-HT) reuptake transporter |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2002-08-14 (United States) |
Mechanism of action
Escitalopram is the S-enantiomer of racemic citalopram and exerts its antidepressant action through inhibition of CNS neuronal reuptake of serotonin (5-HT), resulting in potentiation of serotonergic activity in the central nervous system. In vitro and in vivo animal studies demonstrate that escitalopram is a highly selective SSRI with minimal effects on norepinephrine and dopamine neuronal reuptake. Escitalopram is at least 100-fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and inhibition of 5-HT neuronal firing rate. The drug has no or very low affinity for serotonergic receptors (5-HT 1-7) and other receptors including adrenergic, dopamine, histamine, muscarinic, and benzodiazepine receptors, and does not significantly bind to ion channels (Na+, K+, Cl-, Ca++), which accounts for its favorable side effect profile compared to other psychotropic drugs.
Approved indications
- Generalized anxiety disorder
- Major depressive disorder
Boxed warnings
- WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ see Warnings and Precautions (5.1) ]. Escitalopram is not approved for use in pediatric patients less than 7 years of age [ see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). Escitalopram is not approved for use in pediatric patients less than 7 years of age ( 8.4 ).
Common side effects
- Discontinuation due to adverse event - Major Depressive Disorder Adults
Drug interactions
- Monoamine Oxidase Inhibitors (MAOIs)
- Pimozide
- Other Serotonergic Drugs (SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, St. John's Wort)
- Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin)
Key clinical trials
- Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode (Phase 3)
- An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Escitalopram Oxalate Tablet 20mg [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro (Phase 1)
- Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial (Phase 4)
- A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (Phase 3)
- Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation (NA)
- Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression (Phase 1)
- MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting (Phase 4)
- Serotonin Transporter Genetic Variation and Amygdala Responses to Quetiapine and Selective Serotonin Reuptake Inhibitor Treatment in Major Depression (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lexapro CI brief — competitive landscape report
- Lexapro updates RSS · CI watch RSS
- Generic (originally Lundbeck/Forest) portfolio CI