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amibegron

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: Mar 25, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment680

FDA Designations

No designations recorded

Clinical trial landscape

amibegron · 4 trials · 2 indications

Phase 3 4
NCT00385307Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)Major Depressive Disorder
COMPLETED680 Analytics
NCT00855530Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive DisorderMajor Depressive Disorders
COMPLETED527 Analytics
NCT00825058Efficacy and Safety of SR58611 Compared to Placebo and ParoxetineMajor Depressive Disorders
COMPLETED317 Analytics
NCT00825019Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and ParoxetineMajor Depressive Disorders
COMPLETED306 Analytics
PHASE3COMPLETED
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
Major Depressive DisordersUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine
Major Depressive DisordersUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine
Major Depressive DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in total score of a depression rating scale at 8 weeks
Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists
54 weeks
change from baseline of the total score of the HAM-D 17 items.
6 weeks
change from baseline of the total score of the HAM-D 17 items
6 weeks

Secondary Endpoints

Safety assessments
17-item Hamilton Depression rating Scale, Clinical Global Impression, Sheehan Disability Scale, Qol Enjoyment and satisfaction Questionnaire - Short Form,Medical Outcomes Study Short Form, Endicott Work Productivity Scale.
54 weeks
HAM-D subscores
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
amibegron (SR58611A)DRUG -
placeboDRUGoral administration 12 hours intervals
paroxetineDRUGoral 20 mg/day
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR * Patient meets criteria for a recurrent Major Depressive Episode (MDE) * Patient meets severity assessments of depression specified by the study Excl...

Countries:United StatesArgentinaChileGreeceHong KongMoroccoRussiaSingaporeSouth AfricaSpainTaiwanTunisiaBulgariaCroatiaCzechiaEstoniaFranceMontenegroNetherlandsSerbia
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Frequently asked questions about amibegron

What is amibegron used for?

Amibegron is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is a Phase 3 candidate studied in adult patients with this psychiatric condition. The drug has completed multiple clinical trials evaluating its efficacy and safety in treating depressive symptoms.

Who makes amibegron?

Amibegron is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi has sponsored the clinical development program for this investigational drug, which is currently in Phase 3 trials for Major Depressive Disorder.

What phase is amibegron in?

Amibegron is in Phase 3 clinical development for the treatment of Major Depressive Disorder. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. All four Phase 3 trials listed for amibegron have been completed, with no active trials currently ongoing.

What clinical trials is amibegron in?

Amibegron has completed four Phase 3 clinical trials. These include NCT00385307 (SIRIUS study), NCT00825019, NCT00825058, and NCT00855530. The trials evaluated the efficacy, safety, and tolerability of amibegron in patients with Major Depressive Disorder, with some comparing it to placebo and paroxetine.

Is amibegron the same as SR58611?

Yes, amibegron is also known as SR58611. Clinical trial records for amibegron use the name SR58611, such as in the SIRIUS study (NCT00385307) and other Phase 3 trials. This alternative name is used interchangeably in the clinical development program for this drug.