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Switching: Bupropion-SR
Switching: Bupropion-SR is a Norepinephrine-dopamine reuptake inhibitor Small molecule drug developed by VA Office of Research and Development. It is currently in Phase 3 development for Major depressive disorder, Smoking cessation.
Bupropion-SR is a norepinephrine-dopamine reuptake inhibitor, which increases the levels of these neurotransmitters in the brain.
Bupropion-SR is used to treat Major Depressive Disorder, and it works by inhibiting the sodium-dependent dopamine transporter. This action is due to its classification as a small molecule inhibitor of the dopamine transporter.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Switching: Bupropion-SR |
|---|---|
| Sponsor | VA Office of Research and Development |
| Drug class | Norepinephrine-dopamine reuptake inhibitor |
| Target | Norepinephrine transporter, Dopamine transporter |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
This action is thought to contribute to its antidepressant and smoking cessation effects. Bupropion-SR also has some effect on serotonin levels, but this is less pronounced than its effect on norepinephrine and dopamine.
Approved indications
- Major depressive disorder
- Smoking cessation
Common side effects
- Headache
- Dry mouth
- Insomnia
- Nausea
- Dizziness
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Switching: Bupropion-SR CI brief — competitive landscape report
- Switching: Bupropion-SR updates RSS · CI watch RSS
- VA Office of Research and Development portfolio CI
Frequently asked questions about Switching: Bupropion-SR
What is Switching: Bupropion-SR?
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What does Switching: Bupropion-SR target?
Related
- Drug class: All Norepinephrine-dopamine reuptake inhibitor drugs
- Target: All drugs targeting Norepinephrine transporter, Dopamine transporter
- Manufacturer: VA Office of Research and Development — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Major depressive disorder
- Indication: Drugs for Smoking cessation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing