SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE is indicated for the treatment of Major Depressive Disorder.
How SERTRALINE HYDROCHLORIDE Works
Sertraline is a selective serotonin reuptake inhibitor (SSRI). Its mechanism of action is primarily attributed to the potent and selective inhibition of CNS neuronal reuptake of serotonin (5-HT). This results in an enhancement of serotonergic neurotransmission. In vitro studies demonstrate that sertraline has only weak effects on norepinephrine and dopamine neuronal reuptake and lacks significant affinity for adrenergic, cholinergic, GABAergic, dopaminergic, histaminergic, or serotonergic receptors.
Details
- Status
- Prescription
- First Approved
- 2006-06-30
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, CONCENTRATE
Companies
SERTRALINE HYDROCHLORIDE Approval History
What SERTRALINE HYDROCHLORIDE Treats
1 indicationsSERTRALINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
SERTRALINE HYDROCHLORIDE Boxed Warning
BOXED WARNING Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase ...
BOXED WARNING Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride tablets are not approved for the treatment of major depressive disorder in pediatric patients. (See WARNINGS:Clinical Worsening and Suicide Risk , PRECAUTIONS:Information for Patients , and PRECAUTIONS:Pediatric Use ).
SERTRALINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SERTRALINE HYDROCHLORIDE
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06357104 | SCI-CT-0001 | Ph 4 | completed | Detoxification From the Lipid Tract |
| NCT03068429 FEARCON | 0182/11 | Ph 4 | completed | Fear Conditioned Response in Healthy Subjects and in OCD Patients Pre and Post Treatment With Sertraline. |
| NCT01235195 results posted | A0501097 | Ph 1 | completed | A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SERTRALINE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)SERTRALINE HYDROCHLORIDE is indicated for the treatment of Major Depressive Disorder.
BOXED WARNING Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone consid...
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ZOLOFT
Full clinical data, patents, trials, and competitive landscape for sertraline hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.