Bepirovirsen
drug drugOn this page
Also known as GSK-3228836GSK-3228836BGsk3228836GSK3228836BIONIS HBVRXISIS 505358ISIS-505358ISIS-GSK3RX
Summary
Bepirovirsen (CHEMBL4650468) is a phase-3 clinical-stage oligonucleotide; indicated across 2 conditions including hepatitis b virus infection and chronic hepatitis b virus infection.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Oligonucleotide
- Indications: 2 conditions
- Clinical trials: 14
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4650468 |
| Name | Bepirovirsen |
| Type | Oligonucleotide |
| Max phase | 3 |
Also known as: Bepirovirsen, GSK-3228836, GSK-3228836B, Gsk3228836, GSK3228836, GSK3228836B, IONIS HBVRX, ISIS 505358, ISIS-505358, ISIS-GSK3RX, BEPIROVIRSEN
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
2 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| hepatitis B virus infection | 3 | MONDO:0005344 | EFO:0004197 |
| chronic hepatitis B virus infection | 3 | MONDO:0005366 | EFO:0004239 |
Clinical trials
Total trials: 14.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 7 |
| PHASE1 | 4 |
| PHASE3 | 2 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05630807 | PHASE3 | COMPLETED | Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) |
| NCT05630820 | PHASE3 | COMPLETED | Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) |
| NCT04954859 | PHASE2 | RECRUITING | Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure) |
| NCT06497504 | PHASE2 | ACTIVE_NOT_RECRUITING | Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) |
| NCT06537414 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) |
| NCT04449029 | PHASE2 | COMPLETED | A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB) |
| NCT04544956 | PHASE2 | COMPLETED | A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B |
| NCT04676724 | PHASE2 | COMPLETED | Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB) |
| NCT05276297 | PHASE2 | COMPLETED | A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy |
| NCT05330455 | PHASE1/PHASE2 | TERMINATED | Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection |
| NCT07168356 | PHASE1 | ACTIVE_NOT_RECRUITING | A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease |
| NCT04971928 | PHASE1 | COMPLETED | Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment |
| NCT06058390 | PHASE1 | 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 | PHASE1 | COMPLETED | Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- In clinical trials for: hepatitis B virus infection, chronic hepatitis B virus infection