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Pipeline

Medicine for a medical condition.

Nicotine dependence is driven by changes in the brain, so that’s where we focus too. Cytisinicline is an investigational compound that binds to the α4β2 nicotinic receptors most closely linked to nicotine dependence.14 It’s the focus of our clinical program to help people quit smoking and vaping.

How it works

Cytisinicline binds to nicotinic receptors in the brain, including the α4β2 nicotinic acetylcholine receptor, the receptor most closely linked to nicotine dependence.14

In the Pipeline

The ORCA (Ongoing Research of Cytisinicline for Addiction) program was designed to evaluate cytisinicline’s potential as a new treatment for nicotine dependence.

Cytisinicline
IndicationTrial Phase 1Phase 2Phase 3 Results

Smoking Cessation

Smoking Cessation ORCA-1 (N=254) Completed, through Phase 2 See more on Oxford (opens in a new tab)
Smoking Cessation ORCA-2 (N=810) JAMA Completed, through Phase 3 See more on JAMA (opens in a new tab)
Smoking Cessation ORCA-3 (N=792) JAMA IM Completed, through Phase 3 See more on JAMA IM (opens in a new tab)

E-cigarette Cessation

E-cigarette Cessation ORCA-V1 (N=160) JAMA IM Completed, through Phase 2 See more on JAMA IM (opens in a new tab)
E-cigarette Cessation ORCA-V2 (N=800) Planned, through Phase 3 No results yet

Both*

Both* ORCA-OL (N=475) Completed, through Phase 3
  • Completed
  • Planned

All drug candidates are investigational and are not approved by any regulatory agency. Their safety and effectiveness have not been established.

*Studied in people who smoke and/or use e-cigarettes

Sources: 10, 11, 12

About the Clinical Trials

The ORCA smoking cessation trials enrolled people who had tried to quit before and were still smoking, and a long-term study followed adults still smoking or vaping after an earlier ORCA trial.10,11,13

The ORCA-2 and ORCA-3 trials enrolled the people who smoke today: average age 52, smoking for an average of 36 years, and included people being treated, or on medication for conditions including depression, anxiety, COPD, and cardiovascular risk factors such as hypertension. Many had multiple quit attempts with other treatments, but were still smoking.10,11,13

All studies were conducted in the U.S., with three Phase 3 trials, including a long-term safety study, and a Phase 2 vaping trial, with more than 1,700 participants.10–13

Read the Publications