Cholestasis Treatments

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Brand Name

Bylvay

Generic Name
Odevixibat
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FDA approval date: July 20, 2021
Classification: Ileal Bile Acid Transporter Inhibitor
Form: Capsule

What is Bylvay (Odevixibat)?

BYLVAY is an ileal bile acid transporter inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis .

Approved To Treat

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Related Clinical Trials

Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay)
Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay)
Enrollment Status: Recruiting
Publish Date: April 01, 2026

Summary: This study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) as they use odevixibat in their daily lives. Odevixibat is a medicine that helps people with PFIC, a type of rare disease that makes their liver not work well and causes itching and yellow skin. Odevixibat was first allowed to be used for PFIC in babies older than 6 months by the European Medi...

Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and/or Lactation
Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and/or Lactation
Enrollment Status: Recruiting
Publish Date: April 01, 2026

Summary: The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participant...

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Related Latest Advances

Review Article: Ileal Bile Acid Transport (IBAT) Inhibitors as an Emerging Treatment for Cholestatic Liver Disease.
Review Article: Ileal Bile Acid Transport (IBAT) Inhibitors as an Emerging Treatment for Cholestatic Liver Disease.
Journal: Alimentary pharmacology & therapeutics
Published: December 02, 2025
Remarkable Response to Odevixibat in an Adult With Progressive Familial Intrahepatic Cholestasis Type 1 and Intractable Pruritus.
Remarkable Response to Odevixibat in an Adult With Progressive Familial Intrahepatic Cholestasis Type 1 and Intractable Pruritus.
Journal: ACG case reports journal
Published: November 20, 2025
Odevixibat ameliorates high-fat diet-induced MASLD in mice by targeting the gut microbiota-metabolite axis and enhancing gut-liver crosstalk.
Odevixibat ameliorates high-fat diet-induced MASLD in mice by targeting the gut microbiota-metabolite axis and enhancing gut-liver crosstalk.
Journal: Journal of physiology and biochemistry
Published: November 18, 2025
View All Latest Advances