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Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape
Drug Information

Target Indication

Biliary Atresia

Clinical Trial

NCT04336722

Last updated: 1/2/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA9/19/2024

Kayfanda

Kayfanda is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older (see sections 4.4 and 5.1).

View on EMA
EMA7/16/2021

Bylvay

Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).

OrphanAcceleratedPRIME
View on EMA
Drug Science
Mechanism of action & safety profile
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