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A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers

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Trial Profile

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 May 2024

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At a glance

  • Drugs Cytisinicline (Primary)
  • Indications Smoking withdrawal
  • Focus Registrational; Therapeutic Use
  • Acronyms ORCA-2
  • Sponsors Achieve Life Sciences

    • Most Recent Events

    • 09 May 2024 According to an Achieve Life Sciences media release, data from Phase 3 ORCA-2 study were presented at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting.
    • 11 Jul 2023 Results assessing behavioral support, demonstrated smoking cessation efficacy and excellent tolerability in both 6- and 12-week cytisinicline schedules published in the JAMA: the Journal of the American Medical Association
    • 11 Jul 2023 According to a Achieve Life Sciences media release, based on the results from ORCA-2 & ORCA-3, the company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline as an aid in treating nicotine dependence for smoking cessation in adults trying to quit cigarette smoking in the first half of 2024.

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