Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Comprehensive Report on ALN-HBV-02 (Elebsiran/VIR-2218/BRII-835): An Investigational RNAi Therapeutic for Chronic Hepatitis B and D
1. Executive Summary
ALN-HBV-02, also known by its developmental codenames VIR-2218 and BRII-835, and the proposed international non-proprietary name elebsiran, is an investigational small interfering RNA (siRNA) therapeutic. Originating from Alnylam Pharmaceuticals and co-developed with Vir Biotechnology and Brii Biosciences, ALN-HBV-02 targets hepatitis B virus (HBV) transcripts, primarily aiming to reduce hepatitis B surface antigen (HBsAg) levels. A key innovation is its Enhanced Stabilization Chemistry Plus (ESC+) technology, designed to improve hepatic safety and specificity compared to its precursor, ALN-HBV. Administered subcutaneously, ALN-HBV-02 has demonstrated potent HBsAg reduction in clinical trials for chronic hepatitis B (CHB). While monotherapy shows significant HBsAg knockdown, achieving functional cure (sustained HBsAg loss and anti-HBs seroconversion) typically requires combination with immunomodulators (e.g., pegylated interferon-alfa, therapeutic vaccines) or other antiviral agents (e.g., HBsAg-targeting monoclonal antibodies like tobevibart). The safety profile of ALN-HBV-02 monotherapy appears favorable; in combination regimens, adverse events are generally consistent with the known profiles of the partner drugs. Notably, the combination of elebsiran and tobevibart has shown substantial promise for chronic hepatitis D (CHD), leading to expedited regulatory pathways, including FDA Breakthrough Therapy and Fast Track designations, and EMA PRIME status, with global Phase 3 trials (ECLIPSE program) underway. Ongoing research continues to define optimal combination strategies and long-term outcomes, positioning ALN-HBV-02 as a potentially pivotal component in future curative regimens for CHB and a new therapeutic option for CHD.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/30 | Phase 3 | Recruiting | |||
2023/10/06 | Phase 1 | Active, not recruiting | Virion Therapeutics | ||
2023/08/01 | Phase 2 | Active, not recruiting | |||
2023/05/06 | Phase 1 | Completed | |||
2024/10/15 | Phase 2 | Active, not recruiting | |||
2022/08/02 | Phase 1 | Recruiting | |||
2022/07/18 | Phase 2 | Recruiting | |||
2021/05/18 | Phase 2 | Completed | |||
2021/04/22 | Phase 2 | Active, not recruiting | |||
2020/08/11 | Phase 2 | Completed |
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 |
---|---|---|---|
No EMA approvals found for this drug. |
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 |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.