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NCT06435221 · ClinicalTrials.gov registry record · Phase 3
Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers
A Phase 3 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 479
- Enrollment target
NCT06435221: Completed Phase 3 study, sponsored by Achieve Life Sciences.
NCT06435221 is a Phase 3 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 479 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06435221, a Phase 3 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 479 participants
- Enrollment target
Study Summary
Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.
Interventions
- DRUG Cytisinicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2024-05-28 |
| Est. Completion | 2025-10-06 |
| Phase | Phase 3 |
What the finished NCT06435221 record still lists
NCT06435221 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Cytisinicline is the first listed.
NCT06435221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06435221 about?
NCT06435221 is a clinical study titled "Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers". Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.
What is the current status of trial NCT06435221?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 479 participants. The study started on 2024-05-28. Estimated completion is 2025-10-06.
What interventions are being tested in trial NCT06435221?
The interventions under investigation include: Cytisinicline (DRUG).
Who is sponsoring clinical trial NCT06435221?
This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06435221's enrollment target sits among peer trials
479 804th of 2000 higher than 1,196 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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