Tabex (cytisinicline) / Achieve Life Sciences - LARVOL DELTA

EFFICACY OF 52-WEEK CYTISINICLINE TREATMENT FOR CIGARETTE SMOKING AND E-CIGARETTE CESSATION: THE OPEN-LABEL ORCA-OL TRIAL (CHEST 2026) - No abstract available

Clinical • Late-breaking abstract

Awareness, use and future interest in cytisine for smoking cessation in adults who smoke or have quit within the past year in the UK: A mixed-methods study. (PubMed, Addict Behav Rep) - "Despite low awareness and use of cytisine, interest in future use is high. Addressing informational and practical barriers could support wider cytisine uptake."

Journal • Tobacco Cessation

Efficacy and safety of compound Qingdai enema in rapidly alleviating inflammatory activity in ulcerative colitis: a prospective study. (PubMed, Front Pharmacol) - "The main compounds in CQE were identified, including Gallic acid, Matrine, Oxysophocarpine, Ellagic acid, Prim-O-glucosylcimifugin, Cytisinicline, Danshensu, Protocatechuic acid, Cimifugin, Salvianolic acid A Cytisinicline, Indigo, Indirubin, Tryptanthrin and others...RT-qPCR and WB results demonstrated that the herbal enema helps repair the intestinal mucosal barrier in UC patients. CQE can rapidly alleviate inflammatory activity in UC within 14 days and improve patients' quality of life, with a low incidence of adverse events."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Nurse-led smoking cessation with cytisinicline in primary care: An intervention study. (PubMed, Int J Nurs Stud Adv) - "Higher nicotine dependence and withdrawal symptoms were associated with an increased risk of relapse, whereas a diagnosis of asthma during the study was associated with a lower likelihood of relapse. We suggest that integrating behavioural, pharmacological, and respiratory assessment components within nurse-led primary care pathways may support smoking cessation in routine practice, although causal inferences cannot be established."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Nicotine Addiction • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

Cytisinicline for smoking cessation among patients with a history of cancer: A post-hoc analysis from two phase 3 clinical trials. (ASCO 2026) - P3 | "Cytisinicline was well tolerated and showed numerically higher smoking cessation rates compared with placebo in a small cohort of patients with a history of malignancy. Smoking cessation remains an underutilized but highly modifiable determinant of cancer outcomes, including treatment efficacy, recurrence, and survival. While exploratory in nature, these findings suggest that cytisinicline offers a promising pharmacologic option to support smoking cessation in cancer survivors."

Clinical • P3 data • Retrospective data • Basal Cell Carcinoma • Breast Cancer • Insomnia • Non-melanoma Skin Cancer • Oncology • Sleep Disorder • Solid Tumor • Squamous Cell Carcinoma • Tobacco Cessation

Comparative Effectiveness of Cytisinicline and Varenicline for Smoking Cessation: A Matching-Adjusted Indirect Comparison (MAIC). (PubMed, J Health Econ Outcomes Res) - "Cytisinicline was associated with 82% lower odds of nausea vs varenicline (adjusted OR, 0.18; 95% CI, 0.10-0.31). Cytisinicline may be an effective and more tolerable alternative, especially for patients at risk of relapse or unable to tolerate varenicline."

Clinical • HEOR • Journal • Tobacco Cessation

The effectiveness and value of cytisinicline for smoking cessation: A summary from the institute for clinical and economic review's midwest comparative effectiveness public advisory council. (PubMed, J Manag Care Spec Pharm) - No abstract available

HEOR • Journal • Tobacco Cessation

Utilization and adherence to smoking cessation pharmacotherapy: A population-based study in Spain. (PubMed, Aten Primaria) - "In routine clinical practice, the use of smoking cessation pharmacotherapy remains limited, with low completion of recommended treatment regimens. Differences by sex and socioeconomic status, together with suboptimal treatment completion, highlight the need to strengthen follow-up strategies and improve equity and accessibility within publicly funded cessation programmes."

Journal • Tobacco Cessation

Receptor selectivity of cytisinicline: minimal 5-HT3 binding may explain lower incidence of nausea in smoking cessation therapy. (PubMed, Nicotine Tob Res) - "This study provides pharmacologic evidence that cytisinicline selectively interacts with the α4β2 nicotinic receptor while exhibiting minimal interaction with the 5-HT3 receptor, a key mechanism potentially underlying its improved gastrointestinal tolerability. These findings help explain the lower nausea rates observed in clinical trials and support cytisinicline as a promising alternative to varenicline for smoking cessation, particularly in individuals sensitive to medication-related side effects. This receptor-specific profile may enhance treatment adherence and expand the appeal of pharmacologic smoking cessation strategies."

Journal • Tobacco Cessation

An evaluation of cytisinicline for smoking cessation in adult smokers. (PubMed, Expert Opin Pharmacother) - "If approved and its effectiveness in clinical practice confirms its clinical trial efficacy, cytisinicline will likely join varenicline and combination nicotine replacement as a first-line smoking cessation treatment option. It may also aid cessation of electronic-cigarette vaping or other nicotine-mediated dependence disorders."

Journal • Review • Tobacco Cessation

CYTISINE ATTENUATES T1 RELAXATION ABNORMALITIES AND SLOWS AMYLOID PLAQUE PROGRESSION IN 5XFAD MICE: A LONGITUDINAL MANGANESE-ENHANCED MRI STUDY (ADPD 2026) - "Cytisine/Tabex treatment attenuates T1 relaxation changes and slows amyloid-b plaque formation in 5xFAD mice compared to water controls. These findings support the potential of cytisine as a disease-modifying therapy for AD and demonstrate the utility of MEMRI and MGE-based plaque imaging for monitoring treatment effects in vivo."

Preclinical • Alzheimer's Disease • CNS Disorders • Tobacco Cessation

Comparative Effectiveness of Cytisinicline and Varenicline for Smoking Cessation: A Matching-adjusted Indirect Comparison (MAIC) (ATS 2026) - No abstract available

HEOR • Tobacco Cessation

D3 THE CUTTING EDGE OF TREATMENT FOR NICOTINE ADDICTION: WHAT ALL CLINICIANS SHOULD KNOW (ATS 2026) - "This session will equip clinicians with the most up to date information to help their patients in treating nicotine addiction and also empower them to advocate for tobacco control efforts. Objectives incorporate new guidelines for providing high-quality treatment to adolescents and young adults struggling with nicotine addiction define new strategies to address potential challenges for cessation, such as co-use of cannabis and tobacco products, and understand strategies for addressing nicotine and tobacco use in populations with barriers to cessation better counsel patients about cytisinicline, a new medication for the treatment of nicotine addiction, focusing on supporting evidence and experience with its use"

Clinical • CNS Disorders • Nicotine Addiction • Psychiatry

'For the First time in Forever': Cytisinicline, a New Medication for Nicotine Dependence (ATS 2026) - No abstract available

Nicotine Addiction

ORCA-V2: Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: Achieve Life Sciences

New P3 trial

Do Observational Studies Overestimate the Effectiveness of Cytisinicline? (PubMed, Open Respir Arch) - No abstract available

Journal • Observational data

Efficacy, Safety, and Economic Impact of Cytisinicline Maintenance Therapy in Patients Who Are Candidates for Smoking Cessation: Protocol for a Phase IV, Multicenter, Randomized, Open-Label, Controlled, Parallel Clinical Trial (CITISILONG Trial). (PubMed, JMIR Res Protoc) - "In conclusion, this study evaluates the optimization of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. All of this will improve the effectiveness of smoking cessation by reducing the number of smokers, which implies lower morbidity and mortality and lower costs associated with smoking."

Clinical protocol • HEOR • Journal • P4 data • Tobacco Cessation • NECTIN1

A Pharmacological Update and Safety Analysis of Medications for Smoking Cessation: Which Ones to Use? (PubMed, Curr Pharm Des) - "Nicotine replacement therapy (NRT), drug treatment regimens including nicotinic receptor agonists (varenicline), dopamine and norepinephrine reuptake inhibitors (bupropion), cytisinicline (cytisine), and combination therapy (NRT + medication) can be employed on a case-by-case basis. Endurance of SC is mostly related to the employment of combined approaches, such as counselling and pharmacotherapy. This study is designed to provide an up-to-date overview of the contemporary approach to interventions aimed at helping patients in SC."

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

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