Varenicline
As of the edition of 20 October 2026, Varenicline is a small molecule: marketed, first approved in 2006 (US); acts on CHRNA4; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2006
- Kind
- Small molecule
- Brand name
- Chantix
- First approved
- 10 May 2006 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Viatris; 3 holders in all
- Registered trials
- 231, 22 stopped early
- Disease areas
- Mental health; Chemically induced; Nervous system; Cancer; Immune system; Lungs and airways
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Varenicline.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CHRNA4 | Neuronal acetylcholine receptor subunit alpha-4 | P43681 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 40 | 32 | 4 | 2 |
| Phase 1 | 25 | 19 | 2 | 4 |
| Phase 2 | 57 | 44 | 6 | 4 |
| Phase 3 | 45 | 34 | 5 | 4 |
| Phase 4 | 64 | 46 | 8 | 8 |
| All trials | 231 |