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A Phase 2 trial of Cytisinicline in e-Cigarette Cessation

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Trial Profile

A Phase 2 trial of Cytisinicline in e-Cigarette Cessation

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Aug 2024

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At a glance

  • Drugs Cytisinicline (Primary)
  • Indications Smoking withdrawal
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ORCA-V1
  • Sponsors Achieve Life Sciences

Most Recent Events

  • 31 Jul 2024 According to an Achieve Life Sciences Media Release, company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. Achieve plans to hold an End-of-Phase 2 meeting with the FDAs multidisciplinary team under this Breakthrough Therapy Designation before the end of the year.
  • 17 May 2024 According to an Achieve Life Sciences Media Release, company announced data from the Phase 2 ORCA-V1 vaping cessation trial will be presented today, Friday, May 17, 2024, at the Society of General Internal Medicine (SGIM) Annual Meeting being held in Boston, MA.
  • 06 May 2024 According to an Achieve Life Sciences Media Release, company expects to conduct an End-of-Phase 2 Meeting with the FDA later this year to discuss Phase 3 trial plans.

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