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Drugs in development · updated 30 October 2026

Smoking cessation: drugs in development

As of 30 October 2026 there are 19 active clinical trials (recruiting or ongoing, phases I–III) on 14 drugs for smoking cessation. 4 are experimental, that is not yet approved in the United States.

19Active trials
4Experimental drugs
2Experimental, in phase III

Summary updated every week · data as of 30 October 2026. In Phuturdex you get the full detail of every drug and an email when an alert is published on the ones you follow.

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Experimental drugs

Not yet approved by the US FDA for any indication.

DrugMost advanced phaseActive trialsReference trial
CytisiniclineCytisineIII3NCT05102123
AXS-05III1NCT07766655
PsilocybinPsilocybineII1NCT05452772
ATI-1013I1NCT07215923

Sorted by most advanced phase and number of active trials.

Approved drugs in new trials

Approved by the US FDA for at least one indication, not necessarily this disease, and now in active trials on it.

DrugMost advanced phaseActive trialsReference trial
VareniclineTyrvaya®, Chantix®II–III6NCT05413122
BupropionForfivo Xl®, Aplenzin®III4NCT07766655
NicotineNicotrol®, Nicoderm Cq®II–III4NCT05413122
NaltrexoneVivitrol®, Revia®I–II2NCT07398404
CannabidiolEpidiolex, Epidyolex®II1NCT06218056
NiacinNicotinic acid, Niaspan Titration Starter Pack®II1NCT05452772
Nicotine LozengeII1NCT07099638
TirzepatideZepbound, MounjaroII1NCT07602699
LamivudineEpivir-Hbv®, Epivir®I1NCT07058974
SirolimusRapamycin, Scomara®I1NCT07058974

Sorted by most advanced phase and number of active trials.

All 14 drugs, with the details

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Broader categories

Source: Phuturdex analysis of ClinicalTrials.gov data (U.S. National Library of Medicine), updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III, with at least one identified drug; phase and sites refer to the trials on this disease. Disease name: Wikidata; NLM MeSH term: D016540 “Smoking Cessation”.

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