Last update 07 Nov 2024

FBX-101

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAVrh10.hGALC, FBX 101, FBX101
Target
Mechanism
GALC modulators(Galactocerebrosidase modulators), Gene transference
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 1/2
First Approval Date-
RegulationOrphan Drug (US), Rare Pediatric Disease (US), PRIME (EU), Fast Track (US), Orphan Drug (EU)
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Leukodystrophy, Globoid CellPhase 2
US
05 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
-
hhbmthylob(xvalmfxmys) = FBX-101 significantly increased GALC enzyme activity in white blood cells, improved motor function, and normal brain development bqxeezwtbb (xkalbhccai )
Positive
30 Aug 2022
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Approval

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Regulation

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