Recent Updates
Recently added Catalysts

Amisulpride

Phase 4

Bipolar Disorder | Small molecule | Psychiatry |Sanofi|Trials Updated: Apr 10, 2008

Amisulpride development status

Highest phase Phase 4 (NCT00436371)
Phase scored for SNYPhase 2
Registered trials 9 across 5 sponsors since Aug 2005

Amisulpride target and mechanism

Molecular targetHTR1F, HTR2B, HTR4, HTR1B, HTR3A, HTR1A
Target classAntagonist
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Amisulpride clinical trials

Amisulpride · 1 trial · 1 indication

Phase 2 1
NCT00126009SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I PatientsBipolar Disorder
COMPLETED120 Analytics
PHASE2COMPLETED
SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Combination of the percentage of responders defined by a decrease of at least 50% of the Y-MRS (Young Mania Rating Scale) between D0 and D END and the completion of the 3-month treatment period.

Secondary Endpoints

Other efficacy criteria (such as the changes in Y-MRS scores between D0 and D 21, between D0 and D END.The percentage of remission defined as the Y-MRS < or = 12 at D END...). Safety data (clinical, ECG and laboratory data)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AmisulprideDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Pre-Inclusion Criteria on D-3: * In-patients * From 18 to 65 years old * Able to comply with the protocol * Having given their written informed consent (with a legal representative or a person of trust) * Current diagnosis of bipolar I disorder according to DSM IV TR (APA 2000)...

Countries:CzechiaFrancePolandSlovakiaSpain
Unlock Eligibility Criteria

Frequently asked questions about Amisulpride

What is amisulpride used for in bipolar disorder?

Amisulpride is being studied for use in bipolar disorder, specifically in patients with bipolar I disorder. It has been evaluated in a Phase 2 clinical trial called SOLMANIA, which compared valproate plus amisulpride against valproate plus haloperidol in adults with bipolar I disorder.

What does amisulpride target?

Amisulpride acts as an antagonist at several serotonin receptors: HTR1A, HTR1B, HTR1F, HTR2B, HTR3A, and HTR4. Antagonist activity means the drug blocks signaling through these receptors. This receptor profile places amisulpride among small molecule compounds that modulate serotonin receptor activity.

Who makes amisulpride?

Amisulpride is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company associated with the clinical development of the drug in the bipolar disorder program.

What phase is amisulpride in for bipolar disorder?

Amisulpride is in Phase 2 development for bipolar disorder. It is an investigational small molecule and is not described as approved for this indication. The Phase 2 program includes one completed trial, and no trials are currently active.

What clinical trials is amisulpride in?

Amisulpride has been studied in the Phase 2 SOLMANIA trial, registered as NCT00126009. The trial compared valproate plus amisulpride with valproate plus haloperidol in bipolar I patients, enrolled 120 participants, was randomized, and was conducted in Czechia, France, Poland, Slovakia, and Spain. It is now completed.