Overview
Primary biliary cirrhosis, or PBC, is a progressive and chronic condition that leads to hepatic injury often resulting in end-stage liver failure that requires liver transplantation. Obeticholic acid is a farnesoid-X receptor (FXR) agonist used to treat this condition, possibly allowing for increased survival. In 2016, it was granted approval to treat primary biliary cholangitis in combination with ursodeoxycholic acid, which was previously the mainstay treatment for this condition. In May 2021, the FDA updated its prescribing information to contraindicate the use of obeticholic acid in patients with PBC and advanced cirrhosis (e.g. those with portal hypertension or hepatic decompensation) due to a risk of liver failure, in some cases requiring liver transplantation. Obeticholic acid is currently being considered for FDA approval to treat fibrosis caused by non-alcoholic liver steatohepatitis (NASH). The NDA from Intercept Pharmaceuticals was approved in November 2019 and obeticholic acid is expected to be granted full approval for this indication in 2020.
Indication
用于治疗原发性胆汁性胆管炎(PBC)或用于治疗原发性胆汁性肝硬化（PBC）。
Associated Conditions
- Primary Biliary Cholangitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/04 | Phase 3 | Completed | |||
2023/11/07 | Phase 2 | Recruiting | Intercept Pharmaceuticals | ||
2023/02/23 | Not Applicable | Recruiting | |||
2022/10/10 | Phase 2 | Active, not recruiting | |||
2022/02/03 | Phase 2 | Recruiting | |||
2021/11/24 | Phase 1 | Completed | |||
2021/07/09 | Phase 3 | UNKNOWN | |||
2021/06/25 | Phase 2 | Recruiting | |||
2020/10/20 | Phase 2 | Active, not recruiting | Intercept Pharmaceuticals | ||
2019/09/03 | N/A | Recruiting | University of Leipzig |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Intercept Pharmaceuticals Inc | 69516-010 | ORAL | 10 mg in 1 1 | 10/18/2022 | |
| Intercept Pharmaceuticals Inc | 69516-005 | ORAL | 5 mg in 1 1 | 10/18/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Revoked | 12/12/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OCALIVA obeticholic acid 5 mg tablet bottle | 293379 | Medicine | A | 9/21/2018 | |
| OCALIVA obeticholic acid 10 mg tablet bottle | 293378 | Medicine | A | 9/21/2018 |
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