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Phase 3 ORCA-V2 trial assessing the efficacy and safety of cytisinicline for nicotine e-cigarette cessation

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Trial Profile

Phase 3 ORCA-V2 trial assessing the efficacy and safety of cytisinicline for nicotine e-cigarette cessation

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 10 Dec 2024

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At a glance

  • Drugs Cytisinicline (Primary)
  • Indications Smoking withdrawal
  • Focus Therapeutic Use
  • Acronyms ORCA-V2

    • Most Recent Events

    • 10 Dec 2024 New trial record
    • 03 Dec 2024 According to Achieve Life Sciences media release, company is currently targeting ORCA-V2 to initiate in the third quarter of 2025.
    • 03 Dec 2024 According to Achieve Life Sciences media release, company announced successful outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). Company obtained FDA agreement on the proposed single Phase 3 study design for cytisinicline treatment in vaping cessation and on the additional requirements for submitting a supplemental new drug application (sNDA) to expand cytisinicline for the treatment for vaping cessation.

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