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SSR591813L

Phase 3

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

SSR591813L target and mechanism

ModalitySmall molecule

Also known as SSR591813L (dianicline)

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

SSR591813L clinical trials

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?

SSR591813L is an investigational small molecule developed by Sanofi as an aid to smoking cessation in cigarette smokers. It is also known as dianicline. The compound was studied in a Phase 3 clinical trial in adults aged 18 years and older in the United States and Canada.

What is SSR591813L used for?

SSR591813L was developed as a treatment aid for smoking cessation in cigarette smokers. Its Phase 3 trial enrolled adults who wanted to stop smoking, and the study assessed efficacy and safety of dianicline for tobacco use cessation. It is not approved for any use and remains an investigational therapy.

Who makes SSR591813L?

SSR591813L is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 AMERIDIAN trial of dianicline as an aid to smoking cessation. No other developer or partner is associated with the program based on the trial record.

What phase is SSR591813L in?

SSR591813L reached Phase 3 clinical development. Its single Phase 3 trial, AMERIDIAN, has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for smoking cessation or any other indication.

What clinical trials is SSR591813L in?

SSR591813L was studied in one Phase 3 trial, NCT00387946, titled Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers, also called AMERIDIAN. The trial enrolled 630 participants, was randomized and double blind, and was conducted in the United States and Canada. It is now completed.

Is SSR591813L the same as dianicline?

Yes, SSR591813L is also known as dianicline. The two names refer to the same Sanofi compound, and the Phase 3 smoking cessation trial NCT00387946 is listed under the dianicline name. Searches for either term point to the same investigational small molecule program.