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OMS643762

Phase 2

Schizophrenia | Small molecule | Psychiatry |Omeros Corporation|Last Updated: Oct 22, 2018

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01952132Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia SubjectsPHASE2 COMPLETED 40Sep 1, 2013Apr 1, 2014Oct 22, 20181 United States
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Study Endpoints
Primary Endpoints
Safety
14 days

Incidence of adverse events

Secondary Endpoints
Pharmacokinetics
Pre-dose and up to 10 days post-dose
Cognition
Pre-dose and on day 14 of dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OMS643762 Low DoseEXPERIMENTALOrally administering OMS643762 low dose daily for 14 days
OMS643762 High DoseEXPERIMENTALOrally administering OMS643762 high dose daily for 14 days
PlaceboPLACEBO_COMPARATOROrally administering placebo daily for 14 days
OMS643762 Medium DoseEXPERIMENTALOrally administering OMS643762 medium dose daily for 14 days
Interventions
NameTypeDescription
OMS643762DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Competent to provide informed consent. * Voluntarily provide informed consent and Health Insurance Portability and Accounting Act (HIPAA) Authorization in accordance with local regulations and governing Institutional Review Board (IRB) requirements prior to any procedures or e...

Countries:United States
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