Recent Updates
Recently added Catalysts

Saredutant

Phase 3

Anxiety | Small molecule | Psychiatry |Sanofi|Trials Updated: Apr 20, 2018

Saredutant development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Oct 2006

Saredutant target and mechanism

Molecular targetTACR2
Target classAntagonist
ModalitySmall molecule

Also known as Saredutant (SR48968C), saredutant (SR48968), Saredutant succinate (SR48968C)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials13
Total Enrollment5,784

FDA Designations

No designations recorded

Saredutant clinical trials

Saredutant · 13 trials · 5 indications

Phase 3 13
NCT00629551An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive DisorderDepressive Disorder, Major
COMPLETED825 Analytics
NCT00531622An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive DisorderMajor Depressive Disorder
COMPLETED643 Analytics
NCT00429260A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With DepressionDepressive Disorder
COMPLETED125 Analytics
NCT00415142An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive DisorderDepressive Disorder
COMPLETED393 Analytics
NCT00417118An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety DisorderGeneralized Anxiety
COMPLETED365 Analytics
NCT00390650A North-American Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety DisorderAnxiety
COMPLETED366 Analytics
NCT00390533An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety DisorderGeneralized Anxiety
COMPLETED428 Analytics
NCT00336713A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)Depressive Disorder
COMPLETED430 Analytics
NCT00250653A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With DepressionDepressive Disorder
COMPLETED365 Analytics
NCT00250601An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With DepressionDepressive Disorder
COMPLETED460 Analytics
PHASE3COMPLETED
An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
Depressive Disorder, MajorUnlock trial analytics
PHASE3COMPLETED
An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder
Generalized AnxietyUnlock trial analytics
PHASE3COMPLETED
A North-American Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder
AnxietyUnlock trial analytics
PHASE3COMPLETED
An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
Generalized AnxietyUnlock trial analytics
PHASE3COMPLETED
A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)
Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With Depression
Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score
8 weeks
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score
weeks
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
Baseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness score
Baseline, Day 56
The primary endpoint is the change from baseline (Day 56) to Day 63 in the post-baseline average daily number of discontinuation-emergent signs or symptoms from the 17-item Discontinuation-Emergent Signs and Symptoms checklist.
Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Day 56
Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
Baseline, Day 56
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
The time to relapse of depressive symptoms (in days) during the Maintenance Phase.
minimum 24 weeks and maximum 52 weeks
The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event.
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Endpoints

Change from baseline in the Clinical Global Impression severity of illness score
8 weeks
Change from baseline in the HAM-D depressed mood item scores
8 weeks
Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score
Baseline, Day 56
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Saredutant 100mg and Paroxetine 20 mgEXPERIMENTALcombined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
Saredutant 30mg and Paroxetine 20mgEXPERIMENTALcombined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
Paroxetine 20 mg and saredutant placeboACTIVE_COMPARATORparoxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
PlaceboPLACEBO_COMPARATORSaredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase
Saredudant/EscitalopramEXPERIMENTALSaredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
Placebo and EscitalopramACTIVE_COMPARATORPlacebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
Saredutant 100 mgEXPERIMENTALSaredudant100 mg once daily for a maximum of 32 weeks
Escitalopram 10 mgACTIVE_COMPARATOREscitalopram 10 mg once daily for a maximum of 32 weeks
Saredutant 30 mgEXPERIMENTALSaredutant 30 mg once daily for a maximum of 8 weeks

Interventions

NameTypeDescription
saredutant (SR48968)DRUGoral administration,capsules
paroxetineDRUGoral administration, capsules
placeboDRUGoral administration, capsules
escitalopramDRUGoral administration, capsules
SaredutantDRUG -
Saredutant (SR48968C)DRUGoral administration (capsules)
Saredutant succinate (SR48968C)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Outpatients with recurrent Major Depressive Disorder Exclusion Criteria: * Symptoms of current depressive episode for less than 30 days or more than 2 years * Mild depression, as measured by standard clinical research scales * Significant suicide risk * Lack of sexual activi...

Countries:United StatesChileEstoniaGermanyMexicoRussiaSouth AfricaSouth KoreaArgentinaFinlandFranceSwedenCroatiaCzechiaTurkey (Türkiye)BelgiumCanadaItalyAustraliaPortugal
Unlock Eligibility Criteria

Competitive Landscape -Anxiety Disorders 40 trials (matched to "Anxiety")

Frequently asked questions about Saredutant

What is Saredutant used for?

Saredutant is an investigational drug that was studied for major depressive disorder, generalized anxiety disorder, and other depressive and anxiety conditions. It was developed by Sanofi and reached Phase 3 clinical testing. It is not an approved treatment; all eight of its registered trials are completed.

What does Saredutant target?

Saredutant targets TACR2, also known as the neurokinin-2 receptor. It acts as an antagonist at this receptor, meaning it blocks receptor activity. This mechanism was investigated for potential effects in mood and anxiety disorders, though the drug remains investigational.

Who is developing Saredutant?

Saredutant was developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical development program, including Phase 3 trials in major depressive disorder and generalized anxiety disorder. No other developer is listed for this asset.

What phase is Saredutant in?

Saredutant reached Phase 3 clinical development. All eight of its registered trials are completed, and none are currently active. It is an investigational drug and has not been approved for any indication.

What clinical trials is Saredutant in?

Saredutant has been studied in eight completed trials, including NCT00629551 testing it with paroxetine for major depressive disorder, NCT00531622 with escitalopram for major depressive disorder, NCT00429260 evaluating abrupt discontinuation in depression, and NCT00417118 in generalized anxiety disorder. All trials are completed.

Is Saredutant the same as SR48968?

Yes, Saredutant is also known as SR48968C, SR48968, and saredutant succinate (SR48968C). These names refer to the same investigational compound developed by Sanofi for psychiatric indications.