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Uro vaxom

Phase 2

UTI | Small molecule | Infectious Disease |United Therapeutics Corporation|Last Updated: Mar 18, 2020

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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02591901Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)PHASE2 COMPLETED 48Apr 6, 2018Sep 21, 2019Mar 18, 20202 United Kingdom
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Study Endpoints
Primary Endpoints
Checklist or consensus guideline which can be used to measure a symptomatic urinary tract infection and Practicality of carrying out a definitive randomised controlled clinical study
23 months
Secondary Endpoints
Number of participants willing to participate
14 months
Number of successfully collected urine samples via courier
14 months
Drug compliance
14 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Uro VaxomEXPERIMENTALUro Vaxom, Once daily for 3 months
PlaceboPLACEBO_COMPARATORPlacebo identical to main drug in shape and form
Interventions
NameTypeDescription
Uro vaxomDRUGPrevention of recurrent symptomatic lower urinary tract infections
Placebo comparatorOTHERPlacebo comparator
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Have a clinical diagnosis of spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina damage; * Have had the diagnosis of the spinal pathology for at least 12 months; * Have not had any significant changes in the underlying condition for 12 weeks * Be living...

Countries:United Kingdom
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