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ALN-HBV-02

Generic Name
ALN-HBV-02

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: May 19, 2025

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.

Continue reading the full research report

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

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No FDA approvals found for this drug.

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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TGA Drug Approvals

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No TGA approvals found for this drug.

Health Canada Drug Approvals

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No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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No UK EMC drug information found for this drug.

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