Drug Profile
Cytisinicline - Achieve Life Sciences
Alternative Names: Cytisine; Cytisine-Achieve-Life-Sciences; Desmoxan; TabexLatest Information Update: 04 Mar 2024
Price :
$50
*
At a glance
- Originator Sopharma
- Developer Achieve Life Sciences
- Class 2 ring heterocyclic compounds; Alkaloids; Pyridones; Small molecules; Smoking cessation therapies
- Mechanism of Action Alpha4 beta2 nicotinic receptor agonists; Chelating agents
-
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Smoking withdrawal
Most Recent Events
- 29 Feb 2024 Achieve Life Sciences intends to submit New Drug Application to the US FDA for Smoking withdrawal in the first half of 2025
- 29 Feb 2024 Achieve Life Sciences reaches agreement with US FDA on the adequacy and timing of long-term Cytisinicline exposure data requirements for a New Drug Application (NDA)
- 29 Feb 2024 Achieve Life Sciences plans to initiate the “ORCA-OL” open label exposure trial for Smoking withdrawal (PO) in the second quarter of 2024