Overview
Citalopram is an antidepressant belonging to the class of selective serotonin-reuptake inhibitors (SSRIs) widely used to treat the symptoms of depression. It is a racemic bicyclic phthalate derivate and is the only compound with a tertiary amine and 2 nitrogen-containing metabolites among all SSRIs. Citalopram enhances serotonergic transmission through the inhibition of serotonin reuptake, and among all the SSRIs, citalopram appears to be the most selective toward serotonin reuptake inhibition. Specifically, it has a very minimal effect on dopamine and norepinephrine transportation and virtually no affinity for muscarinic, histaminergic, or GABAergic receptors. Citalopram was approved by the FDA in 1998 for the treatment of depression in adults 18 years or older.
Indication
Citalopram is approved by the FDA for treating adults with major depressive disorder. It has also been used off-label to treat various diseases, including but not limited to sexual dysfunction, ethanol abuse, psychiatric conditions such as obsessive-compulsive disorder (OCD), social anxiety disorder, panic disorder, and diabetic neuropathy.
Associated Conditions
- Alcohol Abuse
- Anorexia Nervosa (AN)
- Binge Eating Disorder (BED)
- Bulimia Nervosa
- Depression
- Diabetic Neuropathies
- Generalized Anxiety Disorder
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Post Traumatic Stress Disorder (PTSD)
- Premature Ejaculation
- Premenstrual Dysphoric Disorder (PMDD)
- Separation Anxiety Disorder
- Social Anxiety Disorder (SAD)
Research Report
A Comprehensive Clinical and Pharmacological Review of Citalopram (DB00215)
1.0 Introduction and Drug Identification
1.1 Overview and Classification
Citalopram is a widely prescribed antidepressant medication belonging to the class of selective serotonin reuptake inhibitors (SSRIs).[1] As a small molecule drug, its primary therapeutic application is in the management of major depressive disorder and other mood-related conditions.[1] A defining feature of citalopram is its pharmacological profile; among all SSRIs, it is recognized as one of the most selective inhibitors of serotonin reuptake, a characteristic that fundamentally shapes its clinical efficacy and tolerability.[1]
The global significance of citalopram in mental healthcare is underscored by its inclusion in the World Health Organization (WHO) Model List of Essential Medicines for the treatment of depressive disorders.[2] Its extensive clinical use is further highlighted by prescription statistics; in 2022, it was the 40th most commonly prescribed medication in the United States, accounting for over 15 million prescriptions.[3]
1.2 Historical Development and Regulatory Milestones
The journey of citalopram from laboratory synthesis to a cornerstone of depression treatment illustrates key trends in pharmaceutical development and public health. The molecule was first synthesized in 1972 by the Danish pharmaceutical company Lundbeck, which subsequently patented the compound.[4] The path to market was protracted, involving a rigorous 15-year period of development and clinical trials to establish its efficacy and safety profile.[4] This lengthy timeline is not unusual for neuropsychiatric agents, where demonstrating a clear therapeutic benefit against a complex and variable disease background presents significant scientific and regulatory challenges.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/12/18 | Phase 4 | Recruiting | Tongji University | ||
2024/05/14 | Not Applicable | Recruiting | |||
2024/01/18 | Not Applicable | Completed | |||
2024/01/05 | Phase 1 | Completed | Food and Drug Administration (FDA) | ||
2023/11/14 | N/A | Not yet recruiting | |||
2023/09/22 | N/A | Active, not recruiting | |||
2023/09/06 | Phase 3 | Recruiting | Federico II University | ||
2023/08/30 | Phase 1 | Recruiting | |||
2023/07/24 | Not Applicable | Not yet recruiting | |||
2023/04/03 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
DIRECT RX | 61919-055 | ORAL | 10 mg in 1 1 | 1/22/2020 | |
DIRECT RX | 61919-288 | ORAL | 10 mg in 1 1 | 4/12/2016 | |
Quality Care Products, LLC | 55700-838 | ORAL | 40 mg in 1 1 | 1/30/2020 | |
QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-107 | ORAL | 20 mg in 1 1 | 10/5/2023 | |
Aurobindo Pharma Limited | 65862-074 | ORAL | 10 mg in 5 mL | 8/24/2023 | |
State of Florida DOH Central Pharmacy | 53808-1037 | ORAL | 40 mg in 1 1 | 9/30/2014 | |
Apotheca Inc. | 12634-629 | ORAL | 10 mg in 1 1 | 6/17/2016 | |
QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-108 | ORAL | 40 mg in 1 1 | 10/5/2023 | |
NuCare Pharmaceuticals,Inc. | 68071-1830 | ORAL | 20 mg in 1 1 | 6/24/2021 | |
State of Florida DOH Central Pharmacy | 53808-1077 | ORAL | 40 mg in 1 1 | 12/30/2014 |
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 |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
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 |
---|---|---|---|---|---|
APL-CITALOPRAM citalopram (as hydrobromide) 10 mg film-coated tablet bottle | 184686 | Medicine | A | 7/26/2012 | |
IPC CITALOPRAM citalopram (as hydrobromide) 10 mg tablet blister pack | 441530 | Medicine | A | 8/2/2024 | |
TN CITALOPRAM citalopram (as hydrobromide) 10 mg tablet bottle | 442372 | Medicine | A | 8/2/2024 | |
CITALOPRAM SANDOZ citalopram 40mg (as hydrobromide) film coated tablet bottle | 107062 | Medicine | A | 4/27/2005 | |
CILOPAM citalopram hydrobromide 20 mg tablet bottle | 158865 | Medicine | A | 2/12/2010 | |
APOTEX-CITALOPRAM citalopram 40mg (as hydrobromide) tablet blister pack | 150638 | Medicine | A | 9/5/2008 | |
NOUMED CITALOPRAM citalopram (as hydrobromide) 20mg film coated tablet blister pack | 298195 | Medicine | A | 2/26/2018 | |
CITALOPRAM-ARX citalopram 20 mg (as hydrobromide) tablet blister pack | 337474 | Medicine | A | 6/23/2020 | |
PPA CITALOPRAM citalopram (as hydrobromide) 10 mg tablet bottle | 441616 | Medicine | A | 8/2/2024 | |
PPA CITALOPRAM citalopram (as hydrobromide) 20 mg tablet bottle | 441617 | Medicine | A | 8/2/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
PRISDAL 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Lundbeck Espana S.A. | 60884 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
CITALOPRAM TEVA-RATIOPHARM 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 67581 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
SEREGRA 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Arafarma Group S.A. | 69163 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
SEREGRA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Arafarma Group S.A. | 69164 | 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. |
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