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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/05/11 | Phase 4 | Completed | |||
2018/04/27 | N/A | Recruiting | |||
2018/04/03 | Phase 2 | Completed | |||
2018/03/14 | Phase 4 | Completed | |||
2018/03/09 | N/A | Recruiting | |||
2018/02/15 | Phase 3 | Completed | |||
2018/01/02 | Phase 2 | Terminated | |||
2017/11/17 | Not Applicable | Completed | |||
2017/10/27 | Phase 1 | UNKNOWN | Mazra Mental Health Center | ||
2017/09/27 | N/A | UNKNOWN | Peking University |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Camber Pharmaceuticals | 31722-251 | ORAL | 20 mg in 1 1 | 9/17/2012 | |
| SOLCO HEALTHCARE US, LLC | 43547-280 | ORAL | 5 mg in 1 1 | 7/31/2023 | |
| Quallent Pharmaceuticals Health LLC | 82009-037 | ORAL | 20 mg in 1 1 | 3/10/2023 | |
| Aurobindo Pharma Limited | 65862-373 | ORAL | 5 mg in 1 1 | 2/2/2024 | |
| RedPharm Drug, Inc. | 67296-1408 | ORAL | 5 mg in 1 1 | 1/1/2021 | |
| A-S Medication Solutions | 50090-5131 | ORAL | 10 mg in 1 1 | 8/2/2019 | |
| Bryant Ranch Prepack | 71335-1307 | ORAL | 20 mg in 1 1 | 7/31/2023 | |
| Preferred Pharmaceuticals, Inc. | 68788-7510 | ORAL | 10 mg in 1 1 | 5/23/2023 | |
| Rising Pharma Holdings, Inc. | 16571-757 | ORAL | 20 mg in 1 1 | 5/22/2023 | |
| RedPharm Drug, Inc. | 67296-1528 | ORAL | 20 mg in 1 1 | 1/20/2020 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| IPCA-ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister | 191872 | Medicine | A | 9/25/2012 | |
| ESCITALOPRAM-WGR escitalopram (as oxalate) 10 mg tablet blister | 191845 | Medicine | A | 9/25/2012 | |
| Esital escitalopram (as oxalate) 20mg tablet blister pack | 266744 | Medicine | A | 3/14/2017 | |
| PPA-ESCITALOPRAM escitalopram (as oxalate) 10 mg tablet blister | 191873 | Medicine | A | 9/25/2012 | |
| MYLAN Escitalopram Oxalate Tablets 20 mg Bottle | 225571 | Medicine | A | 7/9/2014 | |
| LOXALATE escitalopram oxalate 20mg tablets bulk pack | 294581 | Medicine | A | 3/28/2018 | |
| BLOOMS ESCITALOPRAM escitalopram (as oxalate) 20 mg film-coated tablet blister pack | 407940 | Medicine | A | 7/31/2023 | |
| MYLAN Escitalopram Tablets 20 mg Bulk | 209996 | Medicine | A | 5/23/2013 | |
| ESCITALOPRAM-STR escitalopram (as oxalate) 20 mg tablet blister pack | 333542 | Medicine | A | 5/4/2020 | |
| ESCITALOPRAM-LAPL escitalopram (as oxalate) 20mg tablet blister pack | 165876 | Medicine | A | 3/23/2011 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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