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Bylvay (ODEVIXIBAT)
Bylvay works by blocking the ileal sodium/bile acid cotransporter, a protein that helps reabsorb bile acids in the intestines.
At a glance
| Generic name | ODEVIXIBAT |
|---|---|
| Sponsor | Ipsen |
| Drug class | Ileal Bile Acid Transporter Inhibitor [EPC] |
| Target | Ileal sodium/bile acid cotransporter |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Odevixibat is reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is common symptom in patients with PFIC and the pathophysiology of pruritus in patients with PFIC is not completely understood. Although the complete mechanism by which odevixibat improves pruritus in PFIC patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by decrease in serum bile acids [see Clinical Pharmacology (12.2)].
Approved indications
- Pruritus in progressive familial intrahepatic cholestasis (PFIC)
Common side effects
- Diarrhea
- Liver test abnormalities
- Vomiting
- Abdominal pain
- Blood bilirubin increased
- Fat-soluble vitamin deficiency
- Splenomegaly
- Dehydration
- Fracture
- Cholelithiasis
- Pruritus
- Transaminases increased (ALT, AST)
Key clinical trials
- Retrospective Observational Study of Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
- Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD) (PHASE3)
- Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome (PHASE3)
- A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
- Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
- Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC (PHASE3)
- An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia (PHASE3)
- A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bylvay CI brief — competitive landscape report
- Bylvay updates RSS · CI watch RSS
- Ipsen portfolio CI