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Riliprubart Prefilled Pen

Phase 3

Polyneuropathy, Inflammatory Demyelinating, Chronic | 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06859099Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDPPHASE3 ENROLLING BY_INVITATION 300 — — Apr 1, 2025Oct 3, 2029May 26, 202645 United States, Argentina +17
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Study Endpoints
Primary Endpoints
Number of participants having any AEs, SAEs, adverse events leading to treatment discontinuation, AESIs, and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, ECGs, and vital signs during the study period
Up to End of Study (approx. 4 years)

adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs

Secondary Endpoints
Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)
From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)
Percentage of participants experiencing improvement from baseline
From Baseline to 3 years
Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time
From Baseline to 3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
riliprubartEXPERIMENTALParticipants receive subcutaneous injection with a riliprubart prefilled pen (PFP)
Interventions
NameTypeDescription
Riliprubart Prefilled Pen (PFP)DRUGPharmaceutical form: Solution Route of administration: Subcutaneous injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participants with chronic inflammatory demyelinating polyneuropathy (CIDP) currently receiving riliprubart who completed treatment in Part B of Study PDY16744, Study EFC17236, ...

Countries:United StatesArgentinaBrazilCanadaChileChinaCzechiaDenmarkFranceGermanyItalyJapanNetherlandsPolandPortugalSerbiaSouth KoreaSpainSweden
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT06859099lastUpdatePostDate: changed
LOWMay 27, 2026NCT06859099lastUpdatePostDate: changed
LOWMay 26, 2026NCT06859099primaryCompletionDate: changed
LOWMay 24, 2026NCT06859099studyFirstPostDate: changed