New fabry drug shows promise in small switch study

NCT ID NCT05843916

Completed Disease control Sponsor: Bio Sidus SA Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested a new version of the drug agalsidase beta (AGA BETA BS) in 20 people with Fabry disease who were already stable on the standard drug Fabrazyme. Participants switched to the new drug for 54 weeks to see if it worked just as well. The main goal was to keep a key disease marker (Lyso-Gb3) at the same level.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: agalsidase beta (AGA BETA BS)
What this could lead to: If successful, this could provide an alternative treatment option for Fabry disease patients currently on Fabrazyme.
What could go wrong: This is a small, early-stage trial with only 20 participants. It tests a biosimilar, not a new drug, so the benefits may be similar to existing treatment. Risks include infusion reactions or lack of long-term safety data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for FABRY DISEASE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Fabry disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FABRY DISEASE

Contacts and locations

Locations

Centro Médico Santa María de la Salud

San Isidro, Buenos Aires, 1642, Argentina
Centro Oncológico Riojano Integral

La Rioja, F5300, Argentina
Clínica Universitaria Reina Fabiola

Córdoba, X5004, Argentina
Instituto de Investigaciones Clínicas Quilmes

Buenos Aires, Argentina
Instituto de Nefrología Pergamino S.R.L

Pergamino, Buenos Aires, 2700, Argentina

More trials for these conditions

Other studies related to the condition(s) this trial covers.