Overview
Escitalopram is a selective serotonin re-uptake inhibitor (SSRI) and the S-enantiomer of racemic citalopram. It is used to restore serotonergic function in the treatment of depression and anxiety. Escitalopram is approximately 150 times more potent than citalopram’s R-enantiomer and is responsible for the vast majority of citalopram’s clinical activity, with some evidence suggesting that the R-enantiomer of racemic citalopram actively dampens the activity of escitalopram rather than existing simply as an inactive enantiomer. Amongst SSRIs, escitalopram exerts the highest degree of selectivity for the serotonin transporter (SERT) relative to other off-targets which may explain its lower rates of adverse effects as compared to other agents in this class. Escitalopram also differentiates itself from other SSRIs via allosteric action on its target - this may be the mechanism responsible for its observed superior efficacy and faster onset compared to other SSRIs.
Indication
Escitalopram is indicated for the acute and maintenance treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years old and older and for the acute treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years old and older. It is additionally indicated for symptomatic relief of obsessive-compulsive disorder (OCD) in Canada.
Associated Conditions
- Anxiety
- Generalized Anxiety Disorder
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
Research Report
Escitalopram: A Comprehensive Pharmacological and Clinical Review
1. Introduction
Escitalopram, the (S)-enantiomer of the racemic bicyclic phthalane derivative citalopram, is a highly selective serotonin reuptake inhibitor (SSRI) widely utilized in the management of major depressive disorder (MDD) and generalized anxiety disorder (GAD).[1] Since its introduction, escitalopram has garnered significant attention due to its distinct pharmacological profile, characterized by high selectivity for the serotonin transporter (SERT) and a unique allosteric binding mechanism, which may contribute to its clinical efficacy and tolerability.[1] It is recognized as the most selective among currently available SSRIs.[1]
This report aims to provide a comprehensive review of escitalopram, encompassing its chemical and physical properties, detailed pharmacology including mechanism of action and pharmacokinetics, clinical applications and dosage guidelines across various populations, evidence from pivotal and comparative clinical trials, its safety and tolerability profile, and pertinent regulatory and market information. The objective is to consolidate current knowledge to inform both clinical practice and further research regarding this important psychotropic agent.
2. Chemical and Physical Properties
2.1. Identification and Nomenclature
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/20 | Not Applicable | Completed | UCLH/UCL Joint Research Office | ||
2025/04/22 | Not Applicable | Recruiting | N/A | ||
2025/02/17 | Phase 2 | Recruiting | Vigonvita Life Sciences | ||
2025/02/13 | Phase 2 | ENROLLING_BY_INVITATION | Kathryn Unruh | ||
2025/01/03 | Not Applicable | Completed | Peking University Sixth Hospital | ||
2024/11/26 | Phase 2 | Not yet recruiting | |||
2024/11/20 | Phase 1 | Not yet recruiting | |||
2024/11/18 | Not Applicable | Recruiting | Gang Wang | ||
2024/11/08 | Phase 1 | Active, not recruiting | |||
2024/11/05 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-1876 | ORAL | 5 mg in 1 1 | 2/23/2024 | |
| A-S Medication Solutions | 50090-5705 | ORAL | 10 mg in 1 1 | 10/5/2020 | |
| BluePoint Laboratories | 68001-455 | ORAL | 10 mg in 1 1 | 2/6/2024 | |
| Northwind Pharmaceuticals, LLC | 51655-449 | ORAL | 10 mg in 1 1 | 10/27/2023 | |
| Proficient Rx LP | 71205-782 | ORAL | 10 mg in 1 1 | 3/1/2023 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8475 | ORAL | 5 mg in 1 1 | 9/8/2023 | |
| Proficient Rx LP | 71205-325 | ORAL | 20 mg in 1 1 | 1/1/2023 | |
| Exelan Pharmaceuticals Inc. | 76282-249 | ORAL | 5 mg in 1 1 | 9/1/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-194 | ORAL | 10 mg in 1 1 | 2/8/2024 | |
| Bryant Ranch Prepack | 71335-0685 | ORAL | 20 mg in 1 1 | 3/29/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| S-OROPRAM FC TABLET 10MG | SIN16777P | TABLET, FILM COATED | 10 mg | 5/11/2023 | |
| LEXAPRO TABLET 5 mg | SIN12365P | TABLET, FILM COATED | 5 mg | 7/23/2003 | |
| LEXAPRO TABLET 20 mg | SIN12362P | TABLET, FILM COATED | 20 mg | 7/23/2003 | |
| LEXAPRO TABLET 15 mg | SIN12364P | TABLET, FILM COATED | 15 mg | 7/23/2003 | |
| LEXAPRO TABLET 10 mg | SIN12363P | TABLET, FILM COATED | 10 mg | 7/23/2003 | |
| Lepax Film-Coated Tablet 10mg | SIN13780P | TABLET, COATED | 10mg | 3/31/2010 | |
| CILENTRA 10 ESCITALOPRAM OXALATE TABLET USP 10MG | SIN17140P | TABLET, FILM COATED | 10mg | 11/15/2024 | |
| CILENTRA 20 ESCITALOPRAM OXALATE TABLET USP 20MG | SIN17139P | TABLET, FILM COATED | 20mg | 11/15/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Escitalopram-TIH escitalopram (as oxalate) 10 mg tablet blister pack | 211387 | Medicine | A | 7/5/2013 | |
| APO-ESCITALOPRAM escitalopram 15 mg tablet bottle | 146014 | Medicine | A | 7/24/2008 | |
| GENRX ESCITALOPRAM escitalopram 20 mg tablet blister pack | 145651 | Medicine | A | 7/24/2008 | |
| LEXAM 10 escitalopram (as oxalate) 10 mg film-coated tablet blister pack | 339922 | Medicine | A | 8/21/2020 | |
| ESCICOR 10 escitalopram (as oxalate) 10mg tablet blister pack | 166139 | Medicine | A | 2/16/2011 | |
| LOXALATE escitalopram oxalate 10mg tablets blister packs | 119964 | Medicine | A | 5/22/2008 | |
| LOXALATE escitalopram oxalate 20mg tablets blister packs | 119966 | Medicine | A | 5/22/2008 | |
| PCA-ESCITALOPRAM escitalopram (as oxalate) 5 mg tablet blister | 191849 | Medicine | A | 9/25/2012 | |
| PPA-ESCITALOPRAM escitalopram (as oxalate) 5 mg tablet blister | 191898 | Medicine | A | 9/25/2012 | |
| NOUMED ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister pack | 298286 | Medicine | A | 2/26/2018 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CIPRALEX MELTZ | 02391457 | Tablet (Orally Disintegrating) - Oral | 20 MG | 10/4/2012 | |
| CIPRALEX MELTZ | 02391449 | Tablet (Orally Disintegrating) - Oral | 10 MG | 10/4/2012 | |
| ACT ESCITALOPRAM ODT | teva canada limited | 02454300 | Tablet (Orally Disintegrating) - Oral | 20 MG | 8/17/2016 |
| ACT ESCITALOPRAM ODT | teva canada limited | 02454297 | Tablet (Orally Disintegrating) - Oral | 10 MG | 8/17/2016 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ESCITALOPRAM SANDOZ 20 MG COMPRIMIDOS BUCODISPERSABLES EFG | Sandoz Farmaceutica S.A. | 78522 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ESCITALOPRAM FLAS STADA 10 MG COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorio Stada S.L. | 78596 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ESCITALOPRAM ACCORD 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 75591 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ESCITALOPRAM FLAS STADA 20 MG COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorio Stada S.L. | 78598 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ESCITALOPRAM ACCORD 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 75592 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ESCITALOPRAM FLAS STADA 15 MG COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorio Stada S.L. | 78597 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ESCITALOPRAM SANDOZ 10 MG COMPRIMIDOS BUCODISPERSABLES EFG | Sandoz Farmaceutica S.A. | 78520 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ESCITALOPRAM ACCORD 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 75593 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.