Last reviewed · How we verify
Livmarli
At a glance
| Generic name | Livmarli |
|---|---|
| Also known as | Maralixibat |
| Sponsor | Mirum Pharmaceuticals, Inc. |
| Target | Ileal sodium/bile acid cotransporter |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Cholestatic pruritus in patients with Alagille syndrome (ALGS)
Common side effects
- Diarrhea
- Abdominal pain
- Vomiting
- Fat-Soluble Vitamin deficiency
- Transaminases increased (ALT, AST)
- Bone Fractures
- Nausea
Serious adverse events
- ALT increase (>3x baseline)
- AST increase (>3x baseline)
- ALT increase (>5x baseline)
- Bilirubin increase above baseline
- ALT increase requiring discontinuation
Key clinical trials
- A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
- Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome in the European Union (LEAP-EU) (PHASE4)
- Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
- Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study (PHASE2, PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Livmarli CI brief — competitive landscape report
- Livmarli updates RSS · CI watch RSS
- Mirum Pharmaceuticals, Inc. portfolio CI