Trial Profile

A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 19 May 2025

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At a glance

Drugs Cytisinicline (Primary)
Indications Smoking withdrawal
Focus Adverse reactions; Registrational
Acronyms ORCA-OL
Sponsors Achieve Life Sciences

Most Recent Events

13 May 2025 According to an Achieve Life Sciences media release, NDA submission planned in June 2025
13 May 2025 According to an Achieve Life Sciences media release, the company announced the third DSMC review on safety data and the DSMC recommended that the study continue as planned with no changes.
11 Mar 2025 According to an Achieve Life Sciences media release, NDA submission planned for the second quarter of 2025.

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