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Riliprubart Prefilled Pen

Phase 3

Polyneuropathy, Inflammatory Demyelinating, Chronic | Small molecule | Neurology |Sanofi|Last Updated: Jul 13, 2026

Target and mechanism

ModalitySmall molecule

Also known as Riliprubart, Riliprubart Prefilled Pen (PFP), riliprubart

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

ORPHAN_DRUG

Clinical trial landscape

Riliprubart Prefilled Pen · 1 trial · 1 indication

Phase 3 1
NCT06859099Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDPPolyneuropathy, Inflammatory Demyelinating, Chronic
ENROLLING BY_INVITATION300 Analytics
PHASE3ENROLLING BY_INVITATION
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
Polyneuropathy, Inflammatory Demyelinating, ChronicUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites49

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 StatesArgentinaBrazilCanadaChileChinaCzechiaDenmarkFranceGermanyItalyJapanMexicoNetherlandsPolandPortugalSerbiaSouth KoreaSpainSwedenTurkey (Türkiye)
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Recent Changes (Last 90 Days)

LOWJul 13, 2026NCT06859099lastUpdatePostDate: changed
LOWJul 13, 2026NCT06859099lastUpdatePostDate: changed
LOWJun 12, 2026NCT06859099lastUpdatePostDate: changed
LOWJun 12, 2026NCT06859099lastUpdatePostDate: changed

Frequently asked questions about Riliprubart Prefilled Pen

What is Riliprubart used for?

Riliprubart is an investigational small molecule being developed for chronic inflammatory demyelinating polyneuropathy (CIDP), also known as chronic inflammatory demyelinating polyradiculoneuropathy. It is being studied in adults aged 18 years and older whose usual treatments do not work, as well as in comparison to standard intravenous immunoglobulin (IVIg) therapy.

Who is developing Riliprubart?

Riliprubart is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical development for chronic inflammatory demyelinating polyneuropathy (CIDP).

What phase is Riliprubart in?

Riliprubart is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. It has received orphan drug designation from the FDA for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

What clinical trials is Riliprubart in?

Riliprubart is being studied in three Phase 3 trials. NCT06290128 is an active, not recruiting study in CIDP patients for whom usual treatments do not work. NCT06290141 is recruiting and compares Riliprubart to IVIg. NCT06859099 is an enrolling-by-invitation long-term safety and efficacy study. All trials are randomized, double-blind, and placebo-controlled.

Is Riliprubart the same as Riliprubart Prefilled Pen?

Yes, Riliprubart is also known as Riliprubart Prefilled Pen (PFP) or Riliprubart Prefilled Pen. These names refer to the same drug product, which is being developed by Sanofi for chronic inflammatory demyelinating polyneuropathy (CIDP).

What is the enrollment and design of Riliprubart trials?

The Riliprubart Phase 3 program includes trials with enrollment of 109, 160, and 300 participants across multiple countries including the United States, Canada, Japan, and European nations. The trials are randomized, double-blind, and placebo-controlled, with a minimum participant age of 18 years.