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Tanruprubart

Phase 3

Guillain-Barre Syndrome | Small molecule | Neurology |Annexon, Inc.|Last Updated: May 28, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

FAST_TRACKORPHAN_DRUG

Clinical trial landscape

Tanruprubart · 1 trial · 1 indication

Phase 3 1
NCT07020819An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)Guillain-Barre Syndrome
RECRUITING30 Analytics
PHASE3RECRUITING
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre SyndromeUnlock trial analytics

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 to 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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Frequently asked questions about Tanruprubart

What is Tanruprubart used for?

Tanruprubart is an investigational small molecule being developed for the treatment of Guillain-Barre Syndrome, a rare neurological disorder. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug has received Fast Track and Orphan Drug designations from the FDA.

Who makes Tanruprubart?

Tanruprubart is being developed by Annexon, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ANNX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Guillain-Barre Syndrome.

What phase is Tanruprubart in?

Tanruprubart is currently in Phase 3 clinical development. It is being studied in an open-label, uncontrolled clinical trial for Guillain-Barre Syndrome. The drug has not yet been approved by the FDA and remains investigational. It has received Fast Track and Orphan Drug designations.

What clinical trials is Tanruprubart in?

Tanruprubart is being evaluated in a Phase 3 clinical trial with the identifier NCT07020819, known as the FORWARD Study. This open-label, uncontrolled trial is recruiting 30 participants with Guillain-Barre Syndrome at sites in the United States and Denmark. The trial is currently recruiting participants aged 12 years and older.

Is Tanruprubart the same as ANX005?

Yes, Tanruprubart is also commonly known as ANX005. The clinical trial NCT07020819 explicitly refers to the drug as Tanruprubart (Also Commonly Known as ANX005). This alternative name is used in the FORWARD Study for participants with Guillain-Barre Syndrome.

What is the FORWARD study for Tanruprubart?

The FORWARD Study is a Phase 3, open-label, uncontrolled clinical trial evaluating Tanruprubart in participants with Guillain-Barre Syndrome. The trial, identified as NCT07020819, is recruiting 30 participants across the United States and Denmark. It is not randomized or double-blinded and does not use a control group.