DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE is indicated for the treatment of Depression.
How DESIPRAMINE HYDROCHLORIDE Works
Desipramine hydrochloride is thought to exert its therapeutic effect by potentiating noradrenergic responses. It acts primarily by inhibiting the presynaptic reuptake of norepinephrine. Compared to other tricyclic antidepressants, it is a more potent inhibitor of norepinephrine reuptake and has a relatively low affinity for serotonin reuptake pumps.
Details
- Status
- Discontinued
- First Approved
- 1987-06-05
- Routes
- ORAL
- Dosage Forms
- TABLET
DESIPRAMINE HYDROCHLORIDE Approval History
What DESIPRAMINE HYDROCHLORIDE Treats
1 indicationsDESIPRAMINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
DESIPRAMINE HYDROCHLORIDE 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 desipramine hydrochloride tablets 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 th...
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 desipramine hydrochloride tablets 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. Desipramine hydrochloride is not approved for use in pediatric patients ( See WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use .)
DESIPRAMINE 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.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00964886 results posted | NURA-019-09S | Ph 2 | completed | Efficacy of Antidepressants in Chronic Back Pain |
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.
DESIPRAMINE HYDROCHLORIDE FDA Label Details
Indications & Usage
DESIPRAMINE HYDROCHLORIDE is indicated for the treatment of Depression.
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 ...
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NORPRAMIN
Full clinical data, patents, trials, and competitive landscape for desipramine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.