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Amisulpride

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00126009SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I PatientsPHASE2 COMPLETED 120 — — May 1, 2004 -Apr 10, 20085 Czechia, France +3
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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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AmisulprideDRUG -
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Eligibility Criteria
Age Range18 Years — 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
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Competitive Landscape -Bipolar Disorder 20 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY4PHASE3KarXT, Lithium, Valproate, Lamotrigine, Xanomeline/Trospium Chloride
AbbVie, Inc.ABBV3PHASE3Cariprazine, ABBV-932, Icalcaprant
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM, Olanzapine
Xenon Pharmaceuticals Inc.XENE2PHASE3Azetukalner
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117568
Rapport Therapeutics, Inc.RAPP1PHASE2RAP-219
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-100
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
LB Pharmaceuticals, Inc.LBRX1PHASE2LB-102
Alzamend Neuro, Inc.ALZN1PHASE1AL001, Lithium carbonate
Unity Health TorontoUBX1NAUndisclosed
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