Tabex (cytisinicline) / Achieve Life Sciences - LARVOL DELTA

ORCA-OL: Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers (clinicaltrials.gov) - P3 | N=479 | Completed | Sponsor: Achieve Life Sciences | Active, not recruiting ➔ Completed | Trial primary completion date: Dec 2025 ➔ Sep 2025

Trial completion • Trial primary completion date • Tobacco Cessation

FDA Accepts Achieve Life Sciences, Inc. (ACHV) NDA Application for Cytisinicline in Smoking Cessation (Yahoo Finance) - "The FDA has also granted a Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026, for cytisinicline for the treatment of nicotine dependence for smoking cessation."

FDA filing • PDUFA • Tobacco Cessation

Achieve was awarded a CNPV for cytisinicline as a treatment for nicotine dependence associated with e-cigarette or vaping cessation. (GlobeNewswire)

FDA event • Tobacco Cessation

Efectividad de la citisiniclina y diagnóstico precoz de EPOC en la atención integral al fumador: protocolo de investigación (PubMed, Rev Esp Salud Publica) - "This study provides an important opportunity to evaluate the effectiveness of cytisinicline for smoking cessation in real-world conditions, while addressing the underdiagnosis of COPD by optimising the use of spirometry in primary care."

Journal • Observational data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Nicotine Addiction • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

Manic episode induced by cytisinicline: a case report (ECNP 2025) - "Several case reports have been published describing varenicline-induced manic episodes...She presented two tonic-seizure with addition of levetiracetam...Hospitalization was required and was treated with aripiprazole, valproate and clonazepam... A 68-year-old woman. Married. Without personal psychiatric history."

Case report • Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Epilepsy • Insomnia • Mental Retardation • Mood Disorders • Nicotine Addiction • Psychiatry • Schizophrenia • Sleep Disorder • Suicidal Ideation • Tobacco Addiction • Tobacco Cessation

Evidence Update on the Efficacy of Cytisinicline by Treatment Regimen: A Rapid Review. (PubMed, Open Respir Arch) - No abstract available

Journal

Combination therapy of cytisinicline and NRTs may increase smoking cessation rates (ERS 2025) - "Combination treatments (combined NRTs, varenicline and NRTs or bupropion) have also been shown to further increase abstinence. A smoking cessation program combining cytisinicline and short-acting NRTs may increase abstinence."

Combination therapy • Preventive care • Tobacco Cessation

Smoking cessation using the new drug cytisinicline: Preliminary Real-life data (ERS 2025) - "Introduction: Cytisinicline (brand name of cytisine), like varenicline, is a partial agonist and antagonist of acetylcholine nicotine receptors. Our preliminary short-term data support the use of cytisinicline for smoking cessation. Cytisinicline seems to be an effective and safe option. Our findings, though, must be confirmed in a larger group of patients for a prolonged follow-up period."

Clinical • Nicotine Addiction • Tobacco Cessation

Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials. (PubMed, Thorax) - P3 | "Cytisinicline significantly increased quitting for smokers with and without COPD and was well tolerated. The findings support cytisinicline as a viable treatment for smokers with COPD who want to quit."

Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • CNS Disorders • Immunology • Nicotine Addiction • Psychiatry • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

Analysis of Effectiveness of Clinical Psychological Care Protocol for Smoking Cessation With Cytisinicline. (PubMed, Arch Bronconeumol) - "The effectiveness of protocol was 68% at the end of treatment, but was reduced to 48.7%, 40.9% and 28.2% at 3rd, 6th and 12th months respectively. Subjects who met more than 80% of treatment adherence doubled their chances of success at 6th month. For each point of craving intensity, measured by the SRC, at the end of the pharmacological treatment the chances of success at 6th month were reduced by 13%. Cytisinicline was safe."

Clinical • Journal • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Pain • Sleep Disorder • Tobacco Cessation

Cytisinicline for 6 or 12 wk increased smoking cessation rates after treatment and up to 24 wk. (PubMed, Ann Intern Med) - "GIM/FP/GP: [Formula: see text] Public Health: [Formula: see text]."

Journal • Tobacco Cessation

Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation (Yahoo Finance) - "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026....Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation."

FDA filing • PDUFA • Tobacco Cessation

Consensus Document SEPAR-AAMR-ALAT-ASONEUMOCITO-SMNCT on Assessment and Treatment for Consumers of New Tobacco and Nicotine Products. (PubMed, Arch Bronconeumol) - "Psychological counseling will be based on psychoeducation, motivational interviewing, and cognitive-behavioral therapy. Nicotine replacement therapy, varenicline, cytisinicline, and burpropion are medications to consider for users of these devices."

Clinical guideline • Journal • Nicotine Addiction

Cytisinicline vs. Varenicline in Tobacco Addiction: A Literature Review Focused on Emotional Regulation, Psychological Symptoms, and Mental Health. (PubMed, Healthcare (Basel)) - "Ultimately, pharmacotherapy choice should be guided by individual clinical features, mental health status, treatment tolerability, and resource availability. Further research is needed to establish cytisinicline's efficacy and safety across diverse clinical contexts, particularly among individuals with severe psychiatric comorbidities."

Journal • Review • CNS Disorders • Mood Disorders • Nicotine Addiction • Psychiatry • Sleep Disorder • Tobacco Addiction • Tobacco Cessation

The effects of cytisinicline for smoking cessation on arterial stiffness, endothelial function, and myocardial performance: a pilot study. (PubMed, Eur Heart J Imaging Methods Pract) - No abstract available

Journal • Tobacco Cessation

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