Wednesday, July 8, 2026

Drug profile · INN

pegunigalsidase alfa-iwxj

pegunigalsidase alfa-iwxj (ELFABRIO) is a globotriosylceramide hydrolytic enzyme. Route of administration: single-use. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — pegunigalsidase alfa-iwxj
US status
approved
Class
Route
SINGLE-USE
Patents
0
Programs
1
Data quality
0.84

Quick answer

pegunigalsidase alfa-iwxj (ELFABRIO) is a globotriosylceramide hydrolytic enzyme. Route of administration: single-use. Current US regulatory status: approved.

Key facts

INN pegunigalsidase alfa-iwxj
Brand ELFABRIO
Mechanism Globotriosylceramide hydrolytic enzyme
Target Globotriosylceramide
Route SINGLE-USE
Formulation VIAL

Mechanism of action

Globotriosylceramide hydrolytic enzyme

Primary target: Globotriosylceramide

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Pegunigalsidase alfa Phase 3 · Protalix Biotherapeutics · Fabry Disease

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. agalsidase beta Alimentary tract and metabolism (A16)
  3. pegunigalsidase alfa Alimentary tract and metabolism (A16)

Frequently asked questions

What is pegunigalsidase alfa-iwxj?

pegunigalsidase alfa-iwxj (ELFABRIO) is a globotriosylceramide hydrolytic enzyme. Route of administration: single-use. Current US regulatory status: approved.

What is the brand name for pegunigalsidase alfa-iwxj?

ELFABRIO is a marketed brand name for pegunigalsidase alfa-iwxj. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pegunigalsidase alfa-iwxj?

pegunigalsidase alfa-iwxj 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.