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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: 21 Sep 2025

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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

  • 03 Sep 2025 According to an Achieve Life Sciences media release, company has announced that the U.S. FDA has accepted the cytisinicline New Drug Application (NDA) for the treatment of smoking cessation in adults. The application is under review process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026.
  • 26 Jun 2025 According to an Achieve Life Sciences media release, based on data from ORCA-2 and ORCA-3 trials , the company 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.
  • 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.

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