Name: Cytisinicline in Smoking cessation: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

7 evidence topics · 6 sources

Original NDA submission

“In June 2025, the company submitted its New Drug Application to the FDA for cytisinicline” (opens the source at this quote in a new tab)

FDA acceptance and proposed indication

“the U.S. Food and Drug Administration (FDA) has accepted the cytisinicline New Drug Application (NDA) for a new treatment for smoking cessation in adults.” (opens the source at this quote in a new tab)

Investigational status

“has not been approved by the Food and Drug Administration for any indication in the United States.” (opens the source at this quote in a new tab)

FDA complete response letter

“CRL Cites Deficiencies at Third-Party Manufacturing Facility” (opens the source at this quote in a new tab)
“No Efficacy or Clinical Safety Deficiencies Identified” (opens the source at this quote in a new tab)

Regulatory submission: NDA resubmission planned for the fourth quarter of 2026

“resubmit the NDA naming Adare as our finished drug product manufacturer for commercial supply in the fourth quarter of 2026” (opens the source at this quote in a new tab)

Unfinished product labeling in the complete response letter

“final product labeling that was not completed by the FDA’s action date.” (opens the source at this quote in a new tab)

Launch: Anticipated after potential approval in the first half of 2027

“Anticipates potential FDA approval in the first half of 2027, followed by U.S. commercial launch” (opens the source at this quote in a new tab)