Cytisinicline
As of the edition of 20 October 2026, Cytisinicline is a small molecule: marketed, first approved in 2025 (ES); acts on CHRNA4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Recigarum
- First approved
- 28 May 2025 (ES)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Adamed Laboratorios S.L.U.
- Registered trials
- 23, 3 stopped early
- Disease areas
- Chemically induced; Mental health; Cancer; Blood and lymph; Heart and blood vessels; Immune system
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CHRNA4 | Neuronal acetylcholine receptor subunit alpha-4 | P43681 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 1 | 1 |
| Phase 1 | 7 | 6 | 0 | 1 |
| Phase 2 | 5 | 2 | 2 | 1 |
| Phase 3 | 5 | 4 | 1 | 0 |
| Phase 4 | 3 | 2 | 0 | 0 |
| All trials | 23 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Achieve Life Sciences | Lead sponsor of trials | 2017 to now |