Nicotine
As of the edition of 20 October 2026, Nicotine is a small molecule: marketed, first approved in 1978 (CH); acts on CHRNA4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Nicorette
- First approved
- 23 March 1978 (CH)
- Approvals on record
- 25 in 5 regions
- Holder of the most recent approval
- MAPPEL INDÚSTRIA DE EMBALAGENS S.A.; 10 holders in all
- Registered trials
- 424, 36 stopped early
- Disease areas
- Mental health; Chemically induced; Cancer; Lungs and airways; Nervous system; Infections
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
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 Nicotine.
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 | 156 | 116 | 17 | 14 |
| Phase 1 | 82 | 66 | 8 | 4 |
| Phase 2 | 69 | 57 | 3 | 8 |
| Phase 3 | 39 | 28 | 5 | 4 |
| Phase 4 | 78 | 61 | 11 | 6 |
| All trials | 424 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Earlier holder | 1996 to now |
| Pfizer | Later holder | 1996 to now |
| Johnson & Johnson | Acquired holder, Later holder and Lead sponsor of trials | 1996 to now |
| Sanofi | Later holder | 1996 to now |
| Novartis | Later holder | 1999 to now |
| Aveva Drug Delivery Systems | Acquired holder | 2004 to now |
| Dr. Reddy's | Acquired holder | 2017 to now |
| Haleon | Acquired holder and Lead sponsor of trials | 2021 to now |