WELLBUTRIN XL (bupropion hydrochloride) · BAUSCH
Wellbutrin XL is an aminoketone antidepressant indicated for the treatment of major depressive disorder and the prevention of seasonal affective disorder. The medication is used in adult patients to manage depressive symptoms as defined by the Diagnostic and Statistical Manual. For seasonal affective disorder, it is specifically utilized to prevent major depressive episodes in patients with a history of autumn-winter seasonal patterns.
How WELLBUTRIN XL Works
While the exact mechanism of action is unknown, the therapeutic effects of bupropion are presumed to be mediated by noradrenergic and dopaminergic mechanisms. The drug functions as a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine. Notably, it does not inhibit the reuptake of serotonin or the activity of monoamine oxidase.
Details
- Status
- Prescription
- First Approved
- 2003-08-28
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
WELLBUTRIN XL Approval History
What WELLBUTRIN XL Treats
2 indicationsWELLBUTRIN XL is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Seasonal Affective Disorder
WELLBUTRIN XL Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [ see Warnings and Precautions (5.1) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of ...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [ see Warnings and Precautions (5.1) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.1) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. ( 5.1 ) • Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )
WELLBUTRIN XL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04526210 results posted | ALXN1840-HV-103 | Ph 1 | completed | Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants |
| NCT03326128 | 1703346 | Ph 2 | terminated | High Dose Bupropion for Smoking Cessation - Pilot Study |
| NCT01574703 CATS results posted | A3051148 2011-005513-37, CATS | Ph 4 | completed | Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. |
| NCT01456936 EAGLES results posted | A3051123 2010-022914-15, EAGLES | Ph 4 | completed | Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders |
| NCT01635972 | 9766-CL-0044 | Ph 1 | completed | Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion |
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.
WELLBUTRIN XL FDA Label Details
Indications & Usage
FDA Label (PDF)Wellbutrin XL is an aminoketone antidepressant, indicated for: • treatment of major depressive disorder (MDD) • prevention of seasonal affective disorder (SAD) 1.1 Major Depressive Disorder (MDD) Wellbutrin XL ® (bupropion hydrochloride extended-release) tablets is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.