Drugs / Cytisine
Cytisine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed nicotine dependence 1 milestone | |||||
| Filed | US (FDA) | — | nicotine dependence | 2025-06-25 | “Announced the U.S. Food and Drug Administration (FDA) accepted the cytisinicline New Drug Application (NDA) for treatment of nicotine dependence for smoking cessation in adults.” achievelifesciences.com ↗ “Separately, Achieve Life Sciences recently announced that the FDA accepted its NDA for cytisinicline for the treatment of nicotine dependence for smoking cessation” achievelifesciences.com ↗ “Achieve announced it submitted its new drug application (NDA) for cytisinicline as a treatment of nicotine dependence for smoking cessation on June 25, 2025.” achievelifesciences.com ↗ “the company submitted its New Drug Application to the FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation” achievelifesciences.com ↗ “In June 2025, Achieve met its target milestone with the submission of an NDA to the FDA for cytisinicline” achievelifesciences.com ↗ |
| Rejected Indication not stated 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | smoking cessation | 2026-06-22 | “Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline.” achievelifesciences.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT05736224 | May → Sep 2023 | skin cancer | Yale University | Completed | Met primary |
| Phase 1 | NCT03848208 | Feb → Sep 2019 | — | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03509948 | Apr → Jun 2018 | — | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03268343 | Aug 2017 | — | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02585024 | Feb 2016 → Mar 2019 | — | University of Auckland, New Zealand | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03303911 | Oct 2017 → Oct 2018 | — | Achieve Life Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 22 trials | ||||||
| Phase 2 | NCT03654105 | Jul 2019 → Dec 2024 overdue | lung cancer | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03709823 | Nov 2018 → Apr 2019 | — | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05102123 | Jan 2024 → Jul 2026 overdue | nicotine dependence | Population Health Research Institute | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02957786 | Sep 2017 → Oct 2019 | — | University of Auckland, New Zealand | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT05729243 | Feb 2023 → Dec 2025 | alcohol-related disorders, nicotine dependence | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 4 | NCT04126135 | Jan 2022 → Mar 2024 | nicotine dependence | Loma Linda University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04286295 | Mar 2022 → Nov 2023 | coronary artery disorder | Ottawa Heart Institute Research Corporation | Terminated | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2/3 | NCT02797587 Comparator | Jul 2017 → Apr 2020 | HIV infectious disease, alcohol-related disorders | Boston Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT05311085 Comparator | May 2022 → May 2024 | — | University of Auckland, New Zealand | Completed | No outcome recorded |
| Phase 3 | NCT04015414 Comparator | Jul 2020 → Sep 2022 | — | University of Zagreb | Completed | No outcome recorded |
| Phase 4 | NCT06832085 Comparator | Apr 2025 → Apr 2027 expected | — | Ottawa Heart Institute Research Corporation | Recruiting | No outcome recorded |
| — | NCT03249428 Comparator | Nov 2025 → Mar 2027 expected | bronchial disorder, mental disorder, nicotine dependence | Ottawa Hospital Research Institute | Enrolling by invitation | No outcome recorded |
| — | NCT06945770 Background | May 2024 → Jan 2025 | — | Ege University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 43
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | Achieve Life Sciences | Regulatory Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA achievelifesciences.com ↗
The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA’s action date. |
| 2026-05-19 | Achieve Life Sciences | Results Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment achievelifesciences.com ↗
This final clinical dataset completes the comprehensive evidence package supporting Achieve's New Drug Application (NDA), demonstrating that cytisinicline maintains a favorable safety profile across extended treatment duration in a diverse population of adults with nicotine dependence. |
| 2026-03-26 | Achieve Life Sciences | Results Achieve Life Sciences Announces Publication in Nicotine & Tobacco Research Linking Cytisinicline's Receptor Selectivity to Low Nausea Rates and Favorable Tolerability achievelifesciences.com ↗
The Nicotine & Tobacco Research publication, entitled “Receptor Selectivity of Cytisinicline: Minimal 5-HT3 Binding May Explain Lower Incidence of Nausea in Smoking Cessation Therapy,” demonstrates that cytisinicline binds to the nicotinic receptor, which is believed to reduce nicotine cravings and support smoking cessation, while showing it has minimal interaction with the serotonin receptor known to trigger nausea. |
| 2026-03-04 | Achieve Life Sciences | Results Achieve Life Sciences Presents Data at SRNT Demonstrating Successful Cessation in Smokers with Extensive Prior Treatment Exposure; and on Participant Experience in the ORCA-OL Study achievelifesciences.com ↗
today announced new data showing that 6 and 12 weeks of cytisinicline delivers meaningful quitting success, regardless of participants' prior use of smoking cessation medications or number of previous quit attempts. |
| 2025-11-03 | Achieve Life Sciences | Regulatory Achieve Life Sciences Meets Key Milestones Advancing Cytisinicline NDA for Smoking Cessation achievelifesciences.com ↗
The company has submitted the 120-day safety update to the U.S. Food and Drug Administration (FDA) as part of the NDA review for cytisinicline. |
| 2025-10-17 | Achieve Life Sciences | Regulatory Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping Cessation achievelifesciences.com ↗
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced that the U.S. Food and Drug Administration (FDA) has awarded the company a Commissioner's National Priority Voucher (CNPV) for cytisinicline as a treatment of nicotine dependence for e-cigarette or vaping cessation. |
| 2025-09-22 | Achieve Life Sciences | Results Achieve Life Sciences Announces Publication in Thorax of Data Demonstrating Cytisinicline’s Potential Efficacy and Tolerability for Smoking Cessation in Individuals with COPD achievelifesciences.com ↗
today announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease (COPD). |
| 2025-09-03 | Achieve Life Sciences | Regulatory Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation achievelifesciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the cytisinicline New Drug Application (NDA) for a new treatment for smoking cessation in adults. |
| 2025-06-26 | Achieve Life Sciences | Regulatory Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation achievelifesciences.com ↗
Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for the treatment of nicotine dependence, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults. |
| 2025-05-20 | Achieve Life Sciences | Results Achieve Life Sciences to Present New Data at the 2025 ATS International Conference Demonstrating that Cytisinicline Reduced Cravings and Nicotine Intake achievelifesciences.com ↗
The oral presentation will highlight the unique benefit of cytisinicline treatment in clinical trials in reducing nicotine cravings which led to reduced nicotine intake, even in individuals who did not achieve complete smoking cessation. |
| 2025-04-21 | Achieve Life Sciences | Results Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine achievelifesciences.com ↗
today announced that complete trial results from its ORCA-3 were published in the Journal of the American Medical Association (JAMA) Internal Medicine. |
| 2025-02-10 | Achieve Life Sciences | Results Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial achievelifesciences.com ↗
Following this second comprehensive review of available safety data, the DSMC stated that it did not identify any unexpected treatment-related adverse events and that the participants’ adherence to their cytisinicline medication was excellent. |
| 2024-12-03 | Achieve Life Sciences | Regulatory Achieve Life Sciences to Advance First Vaping Cessation Therapy After Successful End-of-Phase 2 Meeting with FDA achievelifesciences.com ↗
The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of vaping abstinence with biochemical verification, and other overall study assessments. |
| 2024-07-31 | Achieve Life Sciences | Regulatory Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence achievelifesciences.com ↗ |
| 2024-05-17 | Achieve Life Sciences | Results Achieve Life Sciences Announces Data from Cytisinicline ORCA-V1 Program to be Presented at Society of General Internal Medicine (SGIM) Annual Meeting achievelifesciences.com ↗
In the study, treatment with cytisinicline more than doubled the likelihood of quitting compared to placebo. |
| 2024-05-06 | Achieve Life Sciences | Results Achieve Life Sciences Announces Publication of Cytisinicline Vaping Cessation Trial Results in JAMA Internal Medicine achievelifesciences.com ↗
As reported today, the ORCA-V1 trial demonstrated that biochemically confirmed continuous vaping abstinence during the last 4 weeks of treatment, the primary outcome measure, was significantly higher for cytisinicline treatment compared to placebo. |
| 2024-03-20 | Achieve Life Sciences | Results Achieve Life Sciences Announces Data from Cytisinicline ORCA Program to be Presented at the 2024 Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting achievelifesciences.com ↗
Findings confirmed results from the previous Phase 3 ORCA-2 trial |
| 2024-02-29 | Achieve Life Sciences | Regulatory Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission achievelifesciences.com ↗
Achieve and the FDA have reached agreement that a single, open-label study evaluating for long-term safety exposure of cytisinicline will be sufficient to complete the requirement and enable an NDA submission anticipated in the first half of 2025. |
| 2023-09-11 | Achieve Life Sciences | Results Achieve Life Sciences Announces Presentation of Cytisinicline E-Cigarette Cessation (ORCA-V1) Results at Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting achievelifesciences.com ↗
Additional analyses showed that vaping abstinence with cytisinicline treatment started by the second week of treatment, with the odds of vaping cessation improving throughout the 12-week treatment period. |
| 2023-07-11 | Achieve Life Sciences | Results Achieve Life Sciences Announces Publication of Cytisinicline Phase 3 ORCA-2 Smoking Cessation Trial in Journal of the American Medical Association (JAMA) achievelifesciences.com ↗
The study authors concluded that cytisinicline demonstrated “smoking cessation efficacy and excellent tolerability” in adult smokers. |
| 2023-05-23 | Achieve Life Sciences | Results Achieve Life Sciences Reports Statistically Significant Smoking Cessation Benefit for Cytisinicline in Second, Confirmatory Phase 3 Clinical Trial achievelifesciences.com ↗
ORCA-3 showed a statistically significant benefit in helping people to quit smoking compared to placebo, with low rates of adverse events. |
| 2023-04-20 | Achieve Life Sciences | Results Achieve Life Sciences Announces Positive Phase 2 ORCA-V1 Trial Results Showing Statistically Significant Vaping Cessation Benefit for Participants Treated with Cytisinicline achievelifesciences.com ↗
The vaping cessation rate during weeks 9-12 was 31.8% for cytisinicline compared to 15.1% for placebo. |
| 2023-03-03 | Achieve Life Sciences | Results Achieve Life Sciences Announces Presentation of the Phase 3 ORCA-2 Trial of Cytisinicline at Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting achievelifesciences.com ↗
Additional analyses being reported today confirm that successful abstinence was observed in subgroups of smokers who received cytisinicline, regardless of age, gender, smoking history, or previous quit attempts. |
| 2022-04-27 | Achieve Life Sciences | Results Achieve Life Sciences Announces Successful, Statistically Significant Smoking Cessation Results in Phase 3 ORCA-2 Clinical Trial of Cytisinicline in Adult Smokers achievelifesciences.com ↗
Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced positive topline results from the Phase 3 ORCA-2 trial of cytisinicline. |
| 2021-11-02 | Achieve Life Sciences | Regulatory Achieve Life Sciences Announces FDA Acceptance of IND Application for Cytisinicline’s Second Planned Indication for Nicotine E-cigarette Cessation achievelifesciences.com ↗
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that the U.S. Food and Drug Administration (FDA) has completed its review and accepted an Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users. |
| 2021-09-14 | Achieve Life Sciences | Results Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 21st Annual Society for Research on Nicotine & Tobacco (SRNT-E) Virtual Conference achievelifesciences.com ↗
A subgroup analysis from the ORCA-1 Phase 2 study of smokers who had previously failed Chantix® (varenicline) demonstrated a Week 4 abstinence rate of 51.3% upon treatment with cytisinicline using the three times daily (TID) regimen, compared with 15.8% with placebo (p= 0.009). |
| 2021-04-14 | Achieve Life Sciences | Results Achieve Announces Publication of the ORCA-1 Phase 2b Clinical Trial of Cytisinicline in Adult Smokers in Nicotine and Tobacco Research achievelifesciences.com ↗
Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced publication of the results from the Phase 2b ORCA-1 trial in the scientific journal Nicotine and Tobacco Research. |
| 2021-03-25 | Achieve Life Sciences | Results Achieve Announces Publication of the RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix(R) (varenicline) in Addiction achievelifesciences.com ↗
Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline |
| 2020-09-18 | Achieve Life Sciences | Results Achieve Life Sciences Announces Results from Evaluation of Cytisinicline (cytisine) versus Chantix® (varenicline) in 5-HT3 Receptor Binding Assay Study achievelifesciences.com ↗
Using a radioligand antagonist displacement design, the study reported an IC50 of 0.50 mM for cytisinicline and 0.25 µM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor for varenicline compared to cytisinicline. |
| 2020-09-18 | Achieve Life Sciences | Results Achieve Announces Presentation of Investigator-Led RAUORA Trial Data Demonstrating Significantly Fewer Side Effects with Higher Quit Rates for Cytisinicline (cytisine) Compared to Chantix® (varenicline) in First Head-to-Head Comparative Study achievelifesciences.com ↗
Specifically, continuous abstinence rates at 6 months, verified by exhaled carbon monoxide, were 12.1% for cytisinicline compared to 7.9% for varenicline. |
| 2020-06-29 | Achieve Life Sciences | Results Achieve Announces Successful Results from the Investigator-Initiated RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix® (varenicline) as a Treatment to Quit Smoking achievelifesciences.com ↗
The trial achieved statistical significance in showing that cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at six months. |
| 2020-03-12 | Achieve Life Sciences | Results Achieve Life Sciences Announces Presentation of Additional Cytisinicline Analyses at the Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting achievelifesciences.com ↗
New analyses from the ORCA-1 trial indicate that the cytisinicline benefit, abstinence and reduction in number of cigarettes smoked, was consistently observed across all demographics, smoking history, and clinical trial locations. |
| 2019-09-30 | Achieve Life Sciences | Results Achieve Life Sciences Announces Completion of Maximum Tolerated Dose Study achievelifesciences.com ↗
The results indicate a lack of dose-limiting toxicity as defined by protocol criteria even at the highest 30 mg single, oral dose of cytisinicline evaluated in the study. |
| 2019-09-13 | Achieve Life Sciences | Results Achieve Life Sciences Announces Final Phase 2b ORCA-1 Trial Data Presented at Society for Research on Nicotine & Tobacco Europe (SRNT-E) 19th Annual Conference achievelifesciences.com ↗
Final data included in the oral presentations at SRNT-E indicate statistically significant end-of-treatment abstinence rates of 50-54% for all cytisinicline treatment arms compared to 16% for placebo. |
| 2019-06-11 | Achieve Life Sciences | Results Achieve Life Sciences Announces Statistically Significant Improvement in Quit Rates for Simplified Cytisinicline Dosing Schedule in Phase 2b ORCA-1 Dose-Selection Trial achievelifesciences.com ↗
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company focused on nicotine addiction, today announced positive results from the ORCA-1 dose-selection trial of cytisinicline for smoking cessation. |
| 2019-02-22 | Achieve Life Sciences | Results Achieve Announces Final Data from Cytisinicline Phase I/II Multi-Dose, Pharmacokinetic and Pharmacodynamics (PK/PD) Clinical Study to be Presented at Society for Research on Nicotine & Tobacco Annual Meeting achievelifesciences.com ↗
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced final data from their Phase I/II multi-dose, pharmacokinetic and pharmacodynamics (PK/PD) clinical study of cytisinicline in smokers. |
| 2018-12-18 | Achieve Life Sciences | Regulatory Achieve Announces Update on Cytisinicline Clinical Development Program achievelifesciences.com ↗
The U.S. Food and Drug Administration (FDA) has confirmed that they are in agreement with Achieve's Initial Pediatric Study Plan, specifically, providing a full waiver for evaluating cytisinicline in a pediatric population. |
| 2018-09-27 | Achieve Life Sciences | Results Achieve Announces Results of Clinical Study Demonstrating Similar Bioavailability for a New Cytisine Formulation in Fed and Fasted Subjects achievelifesciences.com ↗
Study results demonstrated bioequivalence when cytisine was administered with or without food. |
| 2018-09-18 | Achieve Life Sciences | Results Achieve Announces Positive Cytisine Data Published in International Journal of Drug Policy achievelifesciences.com ↗
Evaluation of 301 subjects who had used either cytisine or NRT determined that smokers in the cytisine group were approximately three times more likely to achieve 90-days abstinence compared to those who attempted to quit with NRT (p=0.011). |
| 2018-06-26 | Achieve Life Sciences | Results Achieve Announces Positive Cytisine Data Demonstrating No Clinically Significant Drug-Drug Interaction achievelifesciences.com ↗
The study demonstrated that cytisine has no clinically significant interaction with any of the hepatic enzymes commonly responsible for drug metabolism nor clinically significant interaction with drug transporters. |
| 2018-02-20 | Achieve Life Sciences | Results Achieve Announces Preliminary Data from Cytisine Phase I/II Multi-Dose, Pharmacokinetic and Pharmacodynamics (PK/PD) Clinical Study achievelifesciences.com ↗
Smokers in the study were not required to have a designated or predetermined quit date, however, 58% of the subjects overall in the trial achieved biochemically verified smoking abstinence at day 26. |
| 2017-11-14 | Achieve Life Sciences | Results Achieve Announces Results of Clinical Study Demonstrating Similar Bioavailability of Cytisine in Fed and Fasted Subjects achievelifesciences.com ↗
Study results demonstrated bioequivalence when cytisine was administered with or without food. |
| 2017-08-10 | Achieve Life Sciences | Regulatory Achieve Announces FDA Acceptance of the Investigational New Drug Application (IND) for Cytisine as a Smoking Cessation Treatment achievelifesciences.com ↗
Achieve Life Sciences, Inc. (NASDAQ: ACHV) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for cytisine, an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 15 years. |
All press releases naming this drug 56 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cytisine | “The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and...” NCT05736224 ↗ |
| Known as | Cravv | “In Canada, cytisine is marketed as the natural health product Cravv™.” NCT04286295 ↗ |
| Known as | Cytisine, Desmoxan | “Cytisine, Desmoxan” NCT02585024 ↗ |
| Known as | Tabex | “Cytisine (Tabex)” NCT04015414 ↗ |
| Action | Activate | “Cytisine, a partial agonist for the α4β2-nAChR” PMID 30526213 ↗ Jun 2019 |
| Modality | Small molecule | “Cytisine is a naturally occurring alkaloid” NCT03249428 ↗ |
| Route | Oral | “single oral dose of 1.5, 3 or 4.5 mg of cytisine” PMID 30526213 ↗ Jun 2019 |