factor VIII · Altuviiio, ADVATE

What is factor VIII?

ALTUVIIIO is a recombinant Factor VIII fusion protein containing the VWF D'D3 domain, Fc region, and XTEN polypeptides. It replaces missing coagulation Factor VIII and achieves 3- to 4-fold prolonged half-life by preventing endogenous VWF interaction and engaging FcRn-mediated recycling.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Altuviiio, ADVATE, BAY 14-2222, BAY 81-8973

Drug type

Fusion protein

Targets

neonatal Fc receptor (FCGRT) (binding partner it blocks)

Mechanism

Protein replacement: neonatal Fc receptor (FCGRT)

Pathways

coagulation cascade, FcRn-mediated recycling

Therapy area

Hematology

Developer

Bioverativ Therapeutics Inc.

In trials of

TAK

FDA status

Approved as Altuviiio (July 25, 2003), BLA125771 · FDA label

UNII

P89DR4NY54

✅ FDA-approved uses

• Hemophilia A

From the indications section of the FDA label (version of Feb 23, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Von Willebrand Disease (VWD)

Other drugs acting on FCGRT

Sources

• FDA Purple Book
• FDA label (DailyMed)
• FDA label Altuviiio (2026-02-23), indications
• ClinicalTrials.gov NCT05582993

Updated Oct 3, 2026.