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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: 17 Nov 2025

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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

  • 17 Oct 2025 According to an Achieve Life Sciences Media Release, the U.S. Food and Drug Administration (FDA) has awarded the company a Commissioner's National Priority Voucher (CNPV) for cytisinicline as a treatment of nicotine dependence for e-cigarette or vaping cessation. Phase 3 trial along with this phase 2 would support a supplemental New Drug Application (NDA) for vaping cessation indication.
  • 22 Sep 2025 According to an Achieve Life Sciences Media Release, the company conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.
  • 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.

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