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SSR591813L

Phase 3

Smoking Cessation | Small molecule | Psychiatry |Sanofi|Last Updated: Feb 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment630

FDA Designations

No designations recorded

Clinical trial landscape

SSR591813L · 1 trial · 2 indications

Phase 3 1
NCT00387946Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)Smoking Cessation
COMPLETED630 Analytics
PHASE3COMPLETED
Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)
Smoking CessationUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements

Secondary Endpoints

Questionnaire of Smoking Urges to assess craving for cigarettes; Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal, number of smoke-free days, and average number of cigarettes smoked from smoking status interview
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SSR591813L (dianicline)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit. Exclusion Criteria: * Patients who have taken an investigational drug within the past six months prior to the screening visit. * Patients who had a pr...

Countries:United StatesCanada
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Frequently asked questions about SSR591813L

What is SSR591813L used for?

SSR591813L, also known as dianicline, is an investigational small molecule being developed for smoking cessation. It is intended to help cigarette smokers quit smoking. The drug is in Phase 3 clinical development, though the pivotal trial has been completed.

What does SSR591813L target?

SSR591813L targets nicotinic acetylcholine receptors. As a partial agonist, it is designed to reduce the rewarding effects of nicotine and alleviate withdrawal symptoms, thereby aiding smoking cessation. This mechanism is intended to help smokers quit by decreasing cravings and the satisfaction from smoking.

Who makes SSR591813L?

SSR591813L is being developed by Sanofi, a global pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the clinical development and potential commercialization of this investigational drug for smoking cessation.

What phase is SSR591813L in?

SSR591813L is in Phase 3 clinical development. The Phase 3 trial, known as AMERIDIAN, has been completed. However, the drug remains investigational and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated.

What clinical trials is SSR591813L in?

SSR591813L has one completed Phase 3 clinical trial, NCT00387946, titled 'Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)'. This randomized, double-blind trial enrolled 630 participants in the United States and Canada, but it was uncontrolled, meaning there was no placebo or active comparator.

Is SSR591813L the same as dianicline?

Yes, SSR591813L is the same as dianicline. The drug is known by both names, with dianicline being the generic name used in clinical trial documentation. Researchers and investors may encounter either name when reviewing data on this smoking cessation candidate.