TheraRadar
Data updated: Nov 8, 2026

HIBSAGO (bepirovirsen) · GSK

Approved 2026-10-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2026-10-20
Routes
SOLUTION
Dosage Forms
INJECTION

Companies

GSK
Active Ingredient: BEPIROVIRSEN

HIBSAGO Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Oct 2026 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What HIBSAGO Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT05330455 results posted 214760 2021-005117-13, 2023-509684-24 Ph 1, Ph 2 terminated Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
NCT06497504 B-Focus 219231 2023-509588-25, 2023-509588-25-00 Ph 2 active not recruiting Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
NCT05630807 202009 2021-005139-22 Ph 3 completed Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
NCT05630820 219288 2022-002268-53 Ph 3 completed Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
NCT07168356 B-Kind 205872 Ph 1 active not recruiting A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
NCT06537414 B-UNITED 218309 2024-514507-33-00, 2024-514507-33-00 Ph 2 active not recruiting A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
NCT06058390 results posted 219239 Ph 1 completed A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
NCT06422767 results posted 205873 Ph 1 completed Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers
NCT04954859 B-Sure 206882 2023-506867-33, 2021-000554-26 Ph 2 active not recruiting Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
NCT07696520 GSK Biopsy 2025-1414 Ph 2 not yet recruiting Bepirovirsen Liver Biopsy Study
NCT07905157 306775 Ph 1 not yet recruiting A Study to Compare Blood Levels of Bepirovirsen and Safety Using Different Methods of Injecting in Healthy Adult Participants
NCT07908459 B-Ensure 317556 2026-528519-28 Ph 4 not yet recruiting B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

HIBSAGO FDA Label Details

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Data Sources

FDA Approval: NDA221276 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.