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A3309
A3309 is a bile acid sequestrant that binds bile acids in the intestine to increase their fecal excretion and modulate metabolic pathways.
A3309 is a bile acid sequestrant that binds bile acids in the intestine to increase their fecal excretion and modulate metabolic pathways. Used for Cholestasis-related pruritus in progressive familial intrahepatic cholestasis (PFIC), Bile acid diarrhea.
At a glance
| Generic name | A3309 |
|---|---|
| Also known as | Elobixibat |
| Sponsor | Albireo |
| Drug class | Bile acid sequestrant |
| Target | Bile acids / FXR / TGR5 |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Metabolic disease |
| Phase | Phase 2 |
Mechanism of action
By sequestering bile acids in the gut, A3309 prevents their reabsorption in the terminal ileum, leading to increased fecal bile acid loss. This triggers compensatory bile acid synthesis from cholesterol, which can lower cholesterol levels and modulate farnesoid X receptor (FXR) and G-protein coupled bile acid receptor 1 (TGR5) signaling pathways involved in metabolic regulation.
Approved indications
- Cholestasis-related pruritus in progressive familial intrahepatic cholestasis (PFIC)
- Bile acid diarrhea
Common side effects
- Constipation
- Abdominal discomfort
- Nausea
Key clinical trials
- A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH (PHASE2)
- Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen (NA)
- Study of A3309 in Patients With Dyslipidemia (PHASE2)
- Evaluate the Efficacy and Safety of Goofice® (Elobixibat) in Patients With Chronic Constipation (PHASE3)
- Elobixibat for Chronic Constipation Without Defecation Desire (PHASE4)
- Long-term Elobixibat for Chronic Constipation (PHASE4)
- Elobixibat for Chronic Constipation Without Defecation Desire (PHASE4)
- Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Nonalcoholic Fatty Liver Disease (PHASE2)
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:
- A3309 CI brief — competitive landscape report
- A3309 updates RSS · CI watch RSS
- Albireo portfolio CI