Agalsidase Alfa

Summary

Agalsidase Alfa (CHEMBL2108214) is an approved enzyme (ATC A16AB03); indicated across 1 condition including fabry disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Enzyme
• ATC class: A16AB03
• Indications: 1 condition
• Clinical trials: 19

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108214
Name	Agalsidase Alfa
Type	Enzyme
Max phase	4
ATC	A16AB03

Also known as: .alpha.-d-galactopyranosidase, .alpha.-d-galactosidase, Agalsidasa alfa, Agalsidase alfa, Alpha-d-galactosidase, Alpha-galactisidase, DRX-005B, DRX005B, EC 3.2.1.22, Melibiase, Recombinant alpha-galactosidase a, Replagal

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 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
Fabry disease	4	MONDO:0010526	MONDO:0010526

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
PHASE2	7
PHASE3	6
PHASE4	4
PHASE1	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05067868	PHASE4	RECRUITING	A Study of Replagal in Children and Adults With Fabry Disease in India
NCT00097890	PHASE4	COMPLETED	Replagal Enzyme Replacement Therapy for Adults With Fabry Disease
NCT00487630	PHASE4	UNKNOWN	Evaluation of Efficacy and Safety of Agalsidase Beta in Heterozygous Females for Fabry Disease
NCT04143958	PHASE4	WITHDRAWN	To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in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
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
NCT00864851	PHASE3	COMPLETED	Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease
NCT01124643	PHASE3	COMPLETED	Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease
NCT01298141	PHASE3	COMPLETED	A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease
NCT04840667	PHASE3	TERMINATED	A Study of Replagal in Treatment-naïve Adults With Fabry Disease
NCT04974749	PHASE3	COMPLETED	A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease
NCT00048906	PHASE2	COMPLETED	Alpha-Galactosidase A Replacement Therapy for Fabry Disease
NCT00068107	PHASE2	COMPLETED	Dosing Study of Replagal in Patients With Fabry Disease
NCT00071877	PHASE2	COMPLETED	An Open-Label Clinical Trial of Replagal Enzyme Therapy in Children Ages 7-17 Years With Fabry Disease
NCT00075244	PHASE2	COMPLETED	Alternative Dosing and Regimen of Replagal to Treat Fabry Disease
NCT00084084	PHASE2	COMPLETED	Replagal Enzyme Replacement Therapy for Children With Fabry Disease
NCT01196871	PHASE2	COMPLETED	Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease
NCT01304277	PHASE2	COMPLETED	This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.
NCT00357786	PHASE1	COMPLETED	An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal in Patients With Fabry Disease
NCT01031173	Not specified	NO_LONGER_AVAILABLE	Treatment Protocol of Replagal for 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).