Wednesday, July 8, 2026

Drug profile · INN

agalsidase beta

agalsidase beta (FABRAZYME) is a globotriosylceramide hydrolytic enzyme. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A16) A16AB04
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — agalsidase beta
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
INTRAVENOUS
Patents
0
Programs
2
Data quality
0.84

Quick answer

agalsidase beta (FABRAZYME) is a globotriosylceramide hydrolytic enzyme. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN agalsidase beta
Brand FABRAZYME
Mechanism Globotriosylceramide hydrolytic enzyme
Target Globotriosylceramide
Therapeutic class Alimentary tract and metabolism (A16)
Route INTRAVENOUS
Formulation VIAL
ATC code A16AB04

Mechanism of action

Globotriosylceramide hydrolytic enzyme

Primary target: Globotriosylceramide

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. EFC16158 - CARAT Phase 3 · Sanofi-Aventis U.S · Fabry’s disease
  2. agalsidase alfa Phase 3 · Takeda · Fabry Disease

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is agalsidase beta?

agalsidase beta (FABRAZYME) is a globotriosylceramide hydrolytic enzyme. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for agalsidase beta?

FABRAZYME is a marketed brand name for agalsidase beta. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of agalsidase beta?

agalsidase beta has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.