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NCE-1 Intelligence & Market Opportunity

Bylvay

Odevixibat
Hepatoprotective agents
Oral Capsule

Progressive familial intrahepatic cholestasis produces relentless itching from accumulated bile acids, and surgical biliary diversion was long one of the few options. Bylvay (odevixibat) provided a pharmacological alternative.

Odevixibat blocks bile acid reabsorption in the distal intestine, lowering the serum levels that drive severe itch. The once-daily capsule, with a pellet formulation for young children, is approved to treat pruritus in patients with progressive familial intrahepatic cholestasis.

Bylvay has since expanded into Alagille syndrome and holds orphan designation with no generic competition. It competes directly with maralixibat across overlapping cholestatic indications, making label breadth and pediatric formulation the decisive commercial factors.

Approval Date
20-Jul-21
NCE-1 Date
20-Jul-25
NCE Date
20-Jul-26
Commercial snapshot

Market performance & projections

Revenue ($M)
203
CAGR (%)
23.48%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
275
2027
342
2028
408
2029
472
2030
531
2031
565
2032
572
Molecule profile

Details & specifications

Molecule
Odevixibat
Innovator
IPSEN BIOPHARMACEUTICALS, INC.
Dosage Form
Oral Capsule
Strength
1.2 mg, 0.4 mg, 0.6 mg, 0.2 mg
Therapeutic Category
Hepatoprotective agents
Usage
To treat pruritus
Good to know

Frequently asked questions

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