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A second Phase 3 clinical trial evaluating the efficacy and safety of Cytisinicline in Adult Smokers

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Trial Profile

A second Phase 3 clinical trial evaluating the efficacy and safety of Cytisinicline in Adult Smokers

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Apr 2024

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At a glance

  • Drugs Cytisinicline (Primary)
  • Indications Smoking withdrawal
  • Focus Registrational; Therapeutic Use
  • Acronyms ORCA-3
  • Sponsors Achieve Life Sciences
  • Most Recent Events

    • 28 Mar 2024 According to an Achieve Life Sciences media release, data from the study were Presented at Annual SRNT Conference.
    • 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.
    • 23 May 2023 According to an Achieve Life Sciences media release, Dr. Omer Abid is an Investigator of this study.
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