Drugs / Zyban
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ZYBAN | — | 1999-09-10 – 2001-02-07 | fda.gov ↗ |
| Approved | US (FDA) | ZYBAN | — | 1997-05-14 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00108173 | Oct 2002 → Apr 2007 | nicotine dependence | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01806779 | Mar 2013 → Dec 2014 | nicotine dependence | Duke University | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02050308 Background | May 2015 → Mar 2019 | — | Won Choi, PhD, MPH | Completed | No outcome recorded |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zyban | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02050308 ↗ |