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Empasiprubart

Phase 3

Multifocal Motor Neuropathy (MMN) | Monoclonal antibody | Neurology |argenx SE|Last Updated: May 28, 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-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment214
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06742190A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor NeuropathyPHASE3 ACTIVE NOT_RECRUITING 154Dec 18, 2024Dec 1, 2029May 20, 2026109 United States, Australia +24
NCT07610564A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor NeuropathyPHASE1 NOT YET_RECRUITING 60Jun 30, 2026Apr 1, 2030May 28, 2026 -
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Study Endpoints
Primary Endpoints
Change from baseline in grip strength (4-week average) in the most affected hand at week 24
Up to 24 weeks
Change from baseline in nerve CSA at week 24 as measured by ultrasound imaging of the median nerve and brachial plexus (individual nerves and average sum score)
Up to 48 weeks

CSA : cross-sectional area

Secondary Endpoints
Change from baseline in MMN-RODS centile score at week 24
Up to 24 weeks
Change from baseline in mMRC-14 sum score
Up to 24 weeks (Part A), Up to 120 weeks (Part B)
PGI-C actual value
Up to 24 weeks (Part A), Up to 120 weeks (Part B)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A - empasiprubart + IVIg-placeboEXPERIMENTALDuring the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm
Part A - IVIg + empasiprubart-placeboACTIVE_COMPARATORDuring the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm
Part B - empasiprubartEXPERIMENTALAfter completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg)
Empasiprubart IVEXPERIMENTALParticipants receive empasiprubart IV
Interventions
NameTypeDescription
EmpasiprubartBIOLOGICALIntravenous infusion of empasiprubart
IVIG (Intravenous Immunoglobulin)BIOLOGICALIntravenous infusion of IVIg
Empasiprubart-placeboOTHERA placebo resembling the empasiprubart treatment
IVIg-placeboOTHERA placebo resembling the IVIg treatment
Empasiprubart IVBIOLOGICALIntravenous infusions of empasiprubart
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites109

Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies * Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines * Has responded to IVIg in the past 5 years. * Is receiving IVIg at a treatment in...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaDenmarkFranceGermanyGreeceItalyJapanLatviaLithuaniaNetherlandsNorwayPolandPortugalSerbiaSlovakiaSloveniaSpainSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07610564NEW_TRIAL: changed
LOWMay 29, 2026NCT07610564NEW_TRIAL: changed
LOWMay 29, 2026NCT07610564NEW_TRIAL: changed
MEDIUMMay 26, 2026NCT06742190Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06742190studyFirstPostDate: changed