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Riliprubart

Phase 3

Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Small molecule | Neurology |Sanofi|Last Updated: May 26, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment140
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06290128A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not WorkPHASE3 RECRUITING 140Jul 12, 2024Nov 20, 2028May 26, 2026128 United States, Argentina +22
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Study Endpoints
Primary Endpoints
Percentage of participants experiencing a response
Baseline to week 24

A response is defined as a decrease of ≥1 point from baseline in adjusted INCAT disability score at Week 24.

Percentage of participants randomized to riliprubart with lasting response
Baseline to week 48

Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score at week 48 versus baseline.

Percentage of participants randomized to placebo who experience a response
Week 24 to week 48

A response is defined as a decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus week 24.

Secondary Endpoints
Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score
Baseline to week 24
Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score
Baseline to week 24
Change from baseline in grip strength (kilopascals; dominant hand)
Baseline to week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Riliprubart ArmEXPERIMENTALRiliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Placebo ArmPLACEBO_COMPARATORPlacebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Interventions
NameTypeDescription
RiliprubartDRUGPharmaceutical form: Solution Route of administration: IV Infusion
PlaceboDRUGPharmaceutical form: Solution Route of administration: IV Infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites128

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2...

Countries:United StatesArgentinaBelgiumBrazilBulgariaCanadaChileChinaCzechiaDenmarkFranceGermanyGreeceItalyJapanMexicoNetherlandsPolandPortugalSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT06290128lastUpdatePostDate: changed
LOWMay 27, 2026NCT06290128lastUpdatePostDate: changed
LOWMay 26, 2026NCT06290128primaryCompletionDate: changed
LOWMay 24, 2026NCT06290128studyFirstPostDate: changed