Odevixibat
Other Drugs For Bile Therapy
Sold as Bylvay · Kayfanda
- Drug class
- Other Drugs For Bile Therapy
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 9
- FDA reports (12 mo)
- 115
Overview
Plain-language summary, compiled from the cited regulatory records
Odevixibat is a medication belonging to the drug class of other drugs for bile therapy [1]. It is approved for the treatment of pruritus, or itching, in patients aged 3 months and older who have progressive familial intrahepatic cholestasis (PFIC) [1].
Odevixibat is available under the brand name Bylvay [1]. It is important to note that this medication is not recommended for a specific subgroup of PFIC type 2 patients who have certain genetic variants that result in a non-functional or absent bile salt export pump protein [1].
In the past 12 months, there have been 115 adverse event reports associated with odevixibat [2]. The most frequently reported reactions include pruritus, off-label use, liver transplant, diarrhea, and increased bile acids [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 2 | December 31, 2025 |
| EU European Union | EMA | 2 | May 8, 2026 |
| CA Canada | Health Canada | 4 | November 17, 2025 |
| GB United Kingdom | MHRA | 1 | March 7, 2025 |
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis (PFIC) the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
1 ) Limitation of Use : BYLVAY is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein. 1 ) Alagille Syndrome (ALGS) the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS).
1 Progressive Familial Intrahepatic Cholestasis (PFIC) BYLVAY is indicated for the treatment of pruritus in patients 3 months of age and older with PFIC. 1) ]. 2 Alagille Syndrome (ALGS) BYLVAY is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with ALGS.
EUEuropean Union· EMA
2 products
Uses
1).
How to take
CACanada· Health Canada
4 products
4 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (1)
GBUnited Kingdom· MHRA
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
Sources & citations
- [1]FDA DailyMed · 0935cd31-3251-4a… · revised December 29, 2025 [PDF]
- [2]European Medicines Agency · EMEA/H/C/004691 · revised May 8, 2026
- [3]Health Canada (DPD) · 02542641 · revised November 17, 2025
- [4]MHRA (UK) · PLPI459850961 · revised March 7, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.