Tabex (cytisinicline) / Achieve Life Sciences - LARVOL DELTA

Cytisinicline Reduces Cravings and Nicotine Intake in People Who Smoke and Don't Quit Completely (ATS 2025) - "Among participants randomized to cytisinicline treatment who did not achieve complete abstinence, we observed significant reductions in cotinine (i.e., nicotine intake) and lower cravings to smoke. The findings suggest that cytisinicline makes smoking less rewarding and support the hypothesis that cytisinicline functions as both a partial agonist and antagonist at the nicotine acetylcholine receptor. This mechanism underscores cytisinicline's effectiveness as an aid for quitting smoking and highlights the medication's potential role for helping people reduce or quit nicotine vaping and use of other tobacco products that activate the nicotine acetylcholine receptor."

Tobacco Cessation

Comparative effectiveness of cytisinicline versus varenicline: Impact of variability in smoking abstinence measurement (PubMed, Aten Primaria) - No abstract available

HEOR • Journal

Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine (GlobeNewswire) - P3 | N=792 | ORCA-3 (NCT05206370) | Sponsor: Achieve Life Sciences | "Achieve Life Sciences...today announced that complete trial results from its ORCA-3 were published in the Journal of the American Medical Association (JAMA) Internal Medicine. ORCA-3 was the second randomized, placebo-controlled Phase 3 clinical trial evaluating cytisinicline for smoking cessation in 792 U.S. adults. The authors concluded that ORCA-3 reaffirms cytisinicline’s efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks....Achieve plans to submit the cytisinicline New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in June 2025.

FDA filing • P3 data • CNS Disorders

Cytisinicline for Smoking Cessation: The ORCA Phase 3 Replication Randomized Clinical Trial. (PubMed, JAMA Intern Med) - P3 | "As a mechanism of effect, cytisinicline mitigated nicotine craving. ClinicalTrials.gov Identifier: NCT05206370."

Clinical • Journal • P3 data • Tobacco Cessation

Effectiveness of Cytisinicline Treatment in Hospital Smoking Units. (PubMed, Open Respir Arch) - No abstract available

Journal

Cytisin-angio: The Effect of Cytisine Treatment for Smoking Cessation on Cardiovascular Function in Adult Smokers (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: University of Athens

New trial • Cardiovascular • Tobacco Cessation

Key Milestones Reached for ORCA-OL Clinical Trial (GlobeNewswire) - "Achieve has successfully completed enrollment in the cytisinicline ORCA-OL clinical trial, which includes 479 participants across 29 U.S. sites. This study is evaluating the long-term safety of a 3 mg cytisinicline regimen for smoking and vaping cessation, a key requirement for Achieve’s NDA submission planned for the second quarter of 2025. Furthermore, the trial reached the goal of at least 300 participants completing six months of cumulative cytisinicline treatment, as required by the FDA for the company’s planned NDA."

Enrollment closed • FDA filing • Tobacco Cessation

Cytisinicline for vaping cessation. (PubMed, Drug Ther Bull) - No abstract available

Journal

Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation (Cess@Tion) (clinicaltrials.gov) - P3 | N=807 | Completed | Sponsor: University of Auckland, New Zealand | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Tobacco Cessation

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: University of California, Los Angeles | Not yet recruiting ➔ Recruiting

Enrollment open • Nicotine Addiction • Tobacco Addiction • Tobacco Cessation

ORCA-OL: Safety Study of Cytisinicline in Adult Combustible And/or E-cigarette Smokers (clinicaltrials.gov) - P3 | N=650 | Active, not recruiting | Sponsor: Achieve Life Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Tobacco Cessation

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: University of California, Los Angeles

New P2 trial • Nicotine Addiction • Tobacco Addiction • Tobacco Cessation

Cytisinicline For E-Cigarette Cessation. (PubMed, JAMA Intern Med) - No abstract available

Journal

Cytisinicline For E-Cigarette Cessation. (PubMed, JAMA Intern Med) - No abstract available

Journal

Cytisinicline For E-Cigarette Cessation-Reply. (PubMed, JAMA Intern Med) - No abstract available

Journal

MEDSEC-CTA12: 12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence (clinicaltrials.gov) - P4 | N=150 | Not yet recruiting | Sponsor: Maimónides Biomedical Research Institute of Córdoba

New P4 trial • Tobacco Cessation

Prescription of drugs for smoking cessation. Retrospective analysis of the health area of Zamora (PubMed, Aten Primaria) - "The drug intervention had a low reach and poor compliance with the recommended treatment. It is essential to emphasize patient follow-up and drug adherence."

Journal • Retrospective data • Tobacco Cessation

ORCA-OL: Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers (clinicaltrials.gov) - P3 | N=650 | Recruiting | Sponsor: Achieve Life Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Tobacco Cessation

Systematic review and meta-analyses of cytisine to support tobacco cessation. (PubMed, Addiction) - "Cytisine is an effective aid for tobacco cessation and appears to be more effective for tobacco cessation than placebo, no intervention, usual care and nicotine replacement therapy."

Journal • Review • CNS Disorders • Pain • Psychiatry • Tobacco Addiction • Tobacco Cessation

Cytisinicline More Than Doubled Chances of Quitting E-Cigarettes. (PubMed, JAMA) - No abstract available

Journal

ORCA-OL: Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers (clinicaltrials.gov) - P3 | N=650 | Not yet recruiting | Sponsor: Achieve Life Sciences

New P3 trial • Tobacco Cessation

Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial. (PubMed, JAMA Intern Med) - P2 | "These results need confirmation in a larger trial with longer follow-up. ClinicalTrials.gov Identifier: NCT05431387."

Clinical • Journal • Nicotine Addiction

La cytisinicline est-elle efficace pour le sevrage du tabac? (PubMed, Rev Med Suisse) - No abstract available

Journal

Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation (Cess@Tion) (clinicaltrials.gov) - P3 | N=807 | Active, not recruiting | Sponsor: University of Auckland, New Zealand | Recruiting ➔ Active, not recruiting

Enrollment closed • Tobacco Cessation

Cytisinicline increased smoking abstinence at 6 and 12 wk. (PubMed, Ann Intern Med) - "2023;330:152-160. 37432430."

Clinical • Journal • Tobacco Cessation