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dianicline

Phase 3

Smoking | Small molecule | Psychiatry |Sanofi|Trials Updated: Dec 19, 2008

dianicline development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2006

dianicline target and mechanism

Molecular targetCHRNB2, CHRNA4
Target classPartial Agonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment602

FDA Designations

No designations recorded

dianicline clinical trials

dianicline · 1 trial · 1 indication

Phase 3 1
NCT00356967Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking CessationSmoking
COMPLETED602 Analytics
PHASE3COMPLETED
Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation
SmokingUnlock trial analytics

Study Endpoints

Primary Endpoints

to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
exhaled carbon monoxide testing
and plasma cotinine measurements

Secondary Endpoints

questionnaire of smoking urge
Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
dianiclineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months Exclusion Criteria: * Insufficient level of motivation * Another participant in the household * Patients with current psychotic disorder or major depressive disorder The investigator...

Countries:BelgiumDenmarkFranceNorwaySpainSweden
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Frequently asked questions about dianicline

What is dianicline?

Dianicline is an investigational small molecule developed by Sanofi as an aid to smoking cessation. It was studied in a Phase 3 clinical trial in adults aged 18 years and older who wanted to stop smoking. It is not described as an approved therapy and remains a clinical-stage candidate.

What is dianicline used for in smoking cessation?

Dianicline was developed as a smoking cessation aid, intended to help adults quit smoking. Its Phase 3 trial, NCT00356967, evaluated efficacy and safety versus placebo in 602 participants across Belgium, Denmark, France, Norway, Spain, and Sweden. The study enrolled both men and women aged 18 years and older.

What does dianicline target?

Dianicline targets the nicotinic acetylcholine receptor subunits CHRNB2 and CHRNA4. It acts as a partial agonist at these receptors, a mechanism intended to ease nicotine craving and withdrawal symptoms during smoking cessation. This receptor activity is the basis for its investigation as a smoking cessation aid.

Who makes dianicline?

Dianicline is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 smoking cessation trial of dianicline. The compound is a small molecule and is identified in ChEMBL under the ID CHEMBL187927.

What phase is dianicline in?

Dianicline reached Phase 3 clinical development. Its single registered trial, NCT00356967, was a completed Phase 3 study of efficacy and safety versus placebo as an aid to smoking cessation. Dianicline is an investigational agent and is not described as an approved product.

What clinical trials is dianicline in?

Dianicline has been studied in one registered clinical trial, NCT00356967, titled Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation. That Phase 3 trial is completed, was randomized and double blind, and enrolled 602 participants across six European countries.