Drugs / Cytisinicline

Trials 9

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05981768 Aug → Sep 2023 — Achieve Life Sciences Completed No outcome recorded
Phase 1 NCT05631938 Jan → Sep 2023 impaired renal function disease Achieve Life Sciences Completed No outcome recorded
Phase 1 NCT05566288 Oct → Dec 2022 — Achieve Life Sciences Completed No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT06617312 Dec 2024 → Dec 2026 expected nicotine dependence University of California, Los Angeles Recruiting No outcome recorded
Phase 2 NCT05431387 Jul 2022 → Feb 2023 — Achieve Life Sciences Completed Met primary
Phase 33 trials · 2 met primary
Phase 3 NCT06435221 May 2024 → Sep 2025 — Achieve Life Sciences Completed No outcome recorded
Phase 3 NCT05206370 Jan 2022 → Mar 2023 — Achieve Life Sciences Completed Met primary
Phase 3 NCT04576949 Oct 2020 → Dec 2021 — Achieve Life Sciences Completed Met primary
Phase 41 trial
Phase 4 NCT06579846 Jan → Dec 2025 overdue — Maimónides Biomedical Research Institute of Córdoba Not yet recruiting No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT07392125 Comparator May → Nov 2026 expected — Achieve Life Sciences Not yet recruiting No outcome recorded

Press releases naming this drug 82 releases

DateIssuerRelease
2026-09-28 Achieve Life Sciences Achieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026 achievelifesciences.com ↗
2026-06-22 Achieve Life Sciences Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA achievelifesciences.com ↗
2026-05-19 Achieve Life Sciences Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment achievelifesciences.com ↗
2026-03-26 Achieve Life Sciences Achieve Life Sciences Announces Publication in Nicotine & Tobacco Research Linking Cytisinicline's Receptor Selectivity to Low Nausea Rates and Favorable Tolerability achievelifesciences.com ↗
2025-11-06 Achieve Life Sciences Achieve Life Sciences Reports Third Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program achievelifesciences.com ↗
2025-11-03 Achieve Life Sciences Achieve Life Sciences Meets Key Milestones Advancing Cytisinicline NDA for Smoking Cessation achievelifesciences.com ↗
2025-10-17 Achieve Life Sciences 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 ↗
2025-09-22 Achieve Life Sciences 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 ↗
2025-09-03 Achieve Life Sciences Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation achievelifesciences.com ↗
2025-08-07 Achieve Life Sciences Achieve Life Sciences Reports Second Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program achievelifesciences.com ↗
2025-06-26 Achieve Life Sciences Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation achievelifesciences.com ↗
2025-05-20 Achieve Life Sciences Achieve Life Sciences to Present New Data at the 2025 ATS International Conference Demonstrating that Cytisinicline Reduced Cravings and Nicotine Intake achievelifesciences.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 11 sources stand behind the page.

FieldValueCited text
Known as cytisinicline ClinicalTrials.gov intervention name — accepted as the source's own label NCT05631938 ↗
9

NCT05206370 ↗

NCT06579846 ↗

NCT05981768 ↗

NCT04576949 ↗

NCT07392125 ↗

NCT06435221 ↗

NCT05431387 ↗

NCT05566288 ↗

NCT06617312 ↗

Modality Small molecule “plant-based alkaloid” PMID 37432430 ↗ Jul 2023
Route Oral “film-coated oral tablets containing 3 mg cytisinicline” NCT04576949 ↗