Trial Profile

Phase III, Open-label, Switch Over Trial of the Efficacy and Safety of Agalsidase Beta Biosidus (AGA BETA BS) in Fabry Disease Patients Previously Stabilized With Fabrazyme

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 24 Feb 2026

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At a glance

Drugs Agalsidase beta (Primary)
Indications Fabry's disease
Focus Registrational; Therapeutic Use
Acronyms SMILE
Sponsors Biosidus S.A.

Most Recent Events

18 Feb 2026 Status changed from recruiting to completed.
16 Apr 2025 According toBiosidus Media Release,The complete dataset, including final secondary objectives, is expected to be published by the first half of 2025
16 Apr 2025 Interim Results published in the Biosidus Media Release.

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