Overview
Hepatitis D is considered the most severe type of viral hepatitis and leads to the rapid development of cirrhosis, severe decompensation of liver function, and an increased risk of mortality. Until recently, there have been extremely limited treatments available for Hepatitis D infection. Bulevirtide, also known as Hepcludex, is a first-in-class entry inhibitor for the treatment of chronic Hepatitis D infection developed by MYR Pharmaceuticals, now part of Gilead. It was first approved for use in the EU on May 28, 2020; bulevirtide has been granted PRIME scheme eligibility and Orphan Drug Designation by the European Medicines Agency. In the USA, bulevirtide has been granted Orphan Drug Designation and Breakthrough Therapy Designation. Due to potentially beneficial synergistic effects in treating chronic Hepatitis D, bulevirtide is also under investigation in clinical trial NCT03852433 (Phase 2b Study of Bulevirtide With Peginterferon Alfa-2a) in Patients With CHD. Completion of this clinical trial is anticipated in early 2023.
Background
Hepatitis D is considered the most severe type of viral hepatitis and leads to the rapid development of cirrhosis, severe decompensation of liver function, and an increased risk of mortality. Until recently, there have been extremely limited treatments available for Hepatitis D infection. Bulevirtide, also known as Hepcludex, is a first-in-class entry inhibitor for the treatment of chronic Hepatitis D infection developed by MYR Pharmaceuticals, now part of Gilead. It was first approved for use in the EU on May 28, 2020; bulevirtide has been granted PRIME scheme eligibility and Orphan Drug Designation by the European Medicines Agency. In the USA, bulevirtide has been granted Orphan Drug Designation and Breakthrough Therapy Designation. Due to potentially beneficial synergistic effects in treating chronic Hepatitis D, bulevirtide is also under investigation in clinical trial NCT03852433 (Phase 2b Study of Bulevirtide With Peginterferon Alfa-2a) in Patients With CHD. Completion of this clinical trial is anticipated in early 2023.
Indication
Bulevirtide is indicated for the treatment of chronic Hepatitis D infection in HDV-RNA positive adult patients with compensated liver disease.
Associated Conditions
- Hepatitis D
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/17 | N/A | AVAILABLE | |||
2024/07/16 | N/A | Recruiting | |||
2024/05/03 | N/A | Recruiting | |||
2023/11/08 | N/A | Recruiting | |||
2023/09/22 | N/A | Recruiting | Karolinska University Hospital | ||
2023/07/27 | N/A | Completed | |||
2023/07/03 | N/A | Recruiting | University of Athens | ||
2023/03/13 | Phase 1 | Completed | |||
2023/03/08 | Phase 1 | Completed | |||
2023/02/08 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/31/2020 | ||
Authorised | 7/31/2020 |
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 |
|---|---|---|---|---|---|
| HEPCLUDEX bulevirtide (as acetate) 2 mg powder for injection vial | 407179 | Medicine | A | 7/30/2024 |