ZYBAN
LOE ApproachingNDAORALTABLET, EXTENDED RELEASE
Approved
May 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
2/8 — Basic
Drug data last refreshed 5h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYBAN is an oral extended-release small-molecule tablet approved in 1997 for smoking cessation. The drug's mechanism of action and specific indications are not publicly detailed in available data, but it represents a long-established therapeutic option in its category. It is marketed by GSK and remains a standard treatment option despite approaching loss of exclusivity.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure; team focus likely shifting toward lifecycle extension, cost management, or transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
A 7-year Assessment on Subject Understanding of ZYBAN/ WELLBUTRIN Associated Risks
Started Oct 2016
1 enrolled
Depressive Disorder, Major
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
Started Jun 2003
1,005 enrolled
Smoking Cessation
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
Started May 2003
1,005 enrolled
Smoking Cessation
A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
Started Feb 2000
625 enrolled
Smoking Cessation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.