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Tanruprubart

Phase 3

Guillain-Barre Syndrome | Small molecule | Neurology |Annexon, Inc.|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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07020819An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)PHASE3 RECRUITING 30Sep 12, 2025Jun 30, 2028May 28, 202613 United States, Denmark
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Study Endpoints
Primary Endpoints
Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)
Up to Day 15
Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart
Up to Day 15
Secondary Endpoints
Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum
Baseline up to Day 15
Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1
Baseline, Week 1
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TanruprubartEXPERIMENTALParticipants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1.
Interventions
NameTypeDescription
TanruprubartDRUGSolution for IV infusion.
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Eligibility Criteria
Age Range12 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites13

Key Inclusion Criteria: * Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS. * Onset of GBS-related weakness ≤10 days before start of infusion on Day 1 * GBS-disability score (DS) score of 3, 4, or 5 at screening and before start o...

Countries:United StatesDenmark
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07020819lastUpdatePostDate: changed
LOWMay 29, 2026NCT07020819lastUpdatePostDate: changed
LOWMay 29, 2026NCT07020819lastUpdatePostDate: changed
LOWMay 26, 2026NCT07020819primaryCompletionDate: changed
LOWMay 24, 2026NCT07020819studyFirstPostDate: changed