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Prasinezumab

Phase 3

Parkinson's Disease | Small molecule | Neurology |Prothena Corporation plc|Last Updated: May 6, 2026

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-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment900
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07174310A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's DiseasePHASE3 RECRUITING 900Nov 24, 2025Jun 30, 2031May 6, 2026142 United States, Australia +15
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Study Endpoints
Primary Endpoints
Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Up to at least Week 104
Secondary Endpoints
Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score
Baseline, Week 104
Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event
Up to at least Week 104
Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale
Up to at least Week 104
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PrasinezumabEXPERIMENTALParticipants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.
PlaceboEXPERIMENTALParticipants will receive placebo as an IV Infusion.
Interventions
NameTypeDescription
PrasinezumabDRUGParticipants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
PlaceboDRUGParticipants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
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Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites142

Inclusion Criteria: * Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2 * Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria * Has received monotherapy treatment * An MDS-UPDRS Part IV score of 0 at screenin...

Countries:United StatesAustraliaAustriaBrazilCanadaChinaDenmarkFranceGermanyItalyMexicoPolandPortugalSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07174310studyFirstPostDate: changed