Product Description
Bupropion is an antidepressant medication that is now also used in smoking cessation. The drug is FDA-approved for adult depression, seasonal affective disorder, and smoking cessation. Off-label, non-FDA approved uses include anti-depressant-induced sexual dysfunction, attention-deficit/hyperactivity disorder (ADHD), depression associated with bipolar disorder, and obesity. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/29262173/)
Mechanisms of Action: DRI Inhibitor,NaR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Depressive Disorder | Depressive Disorder, Major | Tobacco Use Disorder | Smoking Cessation | Depressive Disorder | Depressive Disorder, Major | Seasonal Affective Disorder | Depressive Disorder | Depressive Disorder, Major | Hypertension | Dyslipidemia | General Diabetes | Type 2 Diabetes | Overweight | Weight Loss
Known Adverse Events: Cardiac Arrhythmias | Tachycardia | Migraine Disorders | Confusion | Dizziness | Headache | Tremor | Insomnia | Constipation | Arthralgia | Rhinitis | Abdominal Pain | Pain Unspecified | Tinnitus | Pharyngitis | Myalgia | Anorexia | Diarrhea
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, China, United States
Active Clinical Trial Count: 9
Highest Development Phases
Phase 2: Neuralgia, Postherpetic|Neuropathic Pain|Smoking Cessation|Tobacco Use Disorder
Phase 1: Adenocarcinoma|Anemia|Depressive Disorder|Esophageal Cancer|Fallopian Tube Cancer|Gastrointestinal Cancer|Healthy Volunteers|Obesity|Ovarian Cancer|Overweight|Peritoneal Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| U1111-1307-0132 | P1 |
Active, not recruiting |
Obesity|Overweight |
2025-11-12 |
|
| UP0132 | P1 |
Recruiting |
Healthy Volunteers |
2025-07-24 |
|
| U1111-1303-9187 | P1 |
Completed |
Healthy Volunteers |
2024-08-20 |
|
| Bupropion for the treatment of peripheral neuropathic pain. | P2 |
Active, not recruiting |
Neuralgia, Postherpetic|Neuropathic Pain |
2022-06-18 |