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agalsidase alfa

Phase 3Protein / enzyme

agalsidase alfa is one of 21 biologic programs targeting Fabry Disease. It is currently in Phase 3.

1

Indications

7

Total Trials

1

Active Trials

20

Competitors

Pipeline

Status by Indication[3][1]

Indication

Fabry DiseaseActive, not recruiting

Fabry DiseasePhase 3

Active, not recruiting

Competition

Competitive Landscape

36 competitors in Fabry Disease

#DrugCompanyPhaseTrials

Fabrazyme (agalsidase Beta)

Venglustat

Active Comparator

Agalsidase

Farxiga

Recombinant Alpha-Galactosidase a

AAssistance Publique - Hôpitaux de Paris

Replagal

Galafold

AAmicus Therapeutics

Migalastat Hcl

AAmicus Therapeutics

agalsidase alfa

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Active, not recruiting

Fabry Disease

NCT05280548

Clinical

Trials by Indication[1]

Fabry Disease6 trials

A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease

Completed· Takeda logo

Takeda·Phase 3·NCT01298141·171 enrolled

Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease

Completed·AAmicus Therapeutics·Phase 2·NCT01196871·20 enrolled

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

Withdrawn· Sanofi logo

Sanofi·Phase 4·NCT04143958

Show 3 more trials

Replagal Enzyme Replacement Therapy for Children With Fabry Disease

Completed· Takeda logo

Takeda·Phase 2·NCT00084084·17 enrolled

Treatment Protocol of Replagal for Patients With Fabry Disease

No longer available· Takeda logo

Takeda··NCT01031173

A Randomized, Open-label, Parallel-group, 18-month Phase 3 Study to Evaluate the Effect of Venglustat Compared With Usual Standard of Care on Left Ventricular Mass Index in Participants With Fabry Disease and Left Ventricular Hypertrophy

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT05280548·104 enrolled

ESS1 trial

This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.

Completed· Takeda logo

Takeda·Phase 2·NCT01304277·17 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for agalsidase alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — agalsidase alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for agalsidase alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: Takeda

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