Agalsidase Beta

Summary

Agalsidase Beta (CHEMBL2108888) is an approved enzyme (ATC A16AB04); indicated across 1 condition including fabry disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Enzyme
• ATC class: A16AB04
• Indications: 1 condition
• Clinical trials: 12

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108888
Name	Agalsidase Beta
Type	Enzyme
Max phase	4
ATC	A16AB04

Also known as: .alpha.–galactosidase, Agalsidasa beta, Agalsidase beta, Fabrazyme, AGALSIDASE BETA

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 indication (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
Fabry disease	4	MONDO:0010526	MONDO:0010526

Clinical trials

Total trials: 12.

Phase distribution

Phase	Trials
PHASE4	7
PHASE3	3
PHASE2	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00081497	PHASE4	COMPLETED	A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
NCT00140621	PHASE4	COMPLETED	A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
NCT00230607	PHASE4	TERMINATED	Study of the Effects of Fabrazyme Treatment on Lactation and Infants
NCT01650779	PHASE4	COMPLETED	A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta
NCT04143958	PHASE4	WITHDRAWN	To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease
NCT05054387	PHASE4	COMPLETED	China Post-marketing Surveillance (PMS) Study of Fabrazyme®
NCT06019728	PHASE4	COMPLETED	A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
NCT05280548	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease
NCT00701415	PHASE3	COMPLETED	A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms
NCT02795676	PHASE3	COMPLETED	Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
NCT01196871	PHASE2	COMPLETED	Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease
NCT05698901	Not specified	RECRUITING	Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry Disease

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).