Drugs / Bepirovirsen
Bepirovirsen
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic hepatitis B virus infection | 2026-04-28 | “the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for bepirovirsen” ionis.com ↗ “the US Food and Drug Administration (FDA) has accepted for priority review a New Drug Application (NDA) for bepirovirsen” gsk.com ↗ “Bepirovirsen, potential functional cure for chronic hepatitis B, regulatory filings accepted in US, EU, China and Japan.” gsk.com ↗ |
| Filed | China (NMPA) | — | chronic hepatitis B virus infection | 2026-03-30 | “the China National Medical Products Administration (NMPA) has accepted for review a new drug application (NDA) for bepirovirsen” gsk.com ↗ “Bepirovirsen, potential functional cure for chronic hepatitis B, regulatory filings accepted in US, EU, China and Japan.” gsk.com ↗ |
| Filed | EU (EMA) | — | chronic hepatitis B virus infection | 2026-03-27 | “the European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) for the use of bepirovirsen” gsk.com ↗ “Bepirovirsen, potential functional cure for chronic hepatitis B, regulatory filings accepted in US, EU, China and Japan.” gsk.com ↗ |
| Filed | Japan (PMDA) | — | chronic hepatitis B virus infection | 2026-02-26 | “Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a new drug application (NDA) for bepirovirsen” gsk.com ↗ “Bepirovirsen, potential functional cure for chronic hepatitis B, regulatory filings accepted in US, EU, China and Japan.” gsk.com ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 1 met primary | ||||||
| Phase 1 | NCT07168356 | Sep 2025 → Mar 2026 overdue | hepatitis B virus infection | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06058390 | Oct 2023 → May 2024 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 1 | NCT04971928 | Sep 2021 → May 2022 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05330455 | Apr 2022 → May 2025 | chronic hepatitis B virus infection | GlaxoSmithKline | Terminated | No outcome recorded Stop: Business |
| Phase 28 trials | ||||||
| Phase 2 | NCT07696520 | Jul 2026 → Dec 2027 expected | chronic hepatitis B virus infection | National University Health System, Singapore | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06537414 | Nov 2024 → May 2027 expected | chronic hepatitis B virus infection | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06497504 | Sep 2024 → Apr 2027 expected | hepatitis B virus infection | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05276297 | Mar 2022 → Aug 2025 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04676724 | Jan 2021 → Feb 2023 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04544956 | Oct 2020 → Nov 2023 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04449029 | Jul 2020 → Mar 2022 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02981602 | Feb 2017 → Dec 2019 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT05630807 | Dec 2022 → Nov 2025 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT05630820 | Dec 2022 → Nov 2025 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT06422767 Comparator | Jul 2024 → Apr 2025 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04954859 Background | Dec 2021 → Jan 2029 expected | hepatitis B virus infection | GlaxoSmithKline | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | GlaxoSmithKline | Regulatory Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B gsk.com ↗
This is the first global approval for bepirovirsen, and the first and only functional cure treatment for CHB approved in Japan. |
| 2026-05-28 | GlaxoSmithKline | Results Bepirovirsen achieves unprecedented functional cure rates with potential to redefine treatment for chronic hepatitis B gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive pivotal data for bepirovirsen, its investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). |
| 2026-05-28 | Ionis Pharmaceuticals | Results Ionis partner GSK announces bepirovirsen achieves unprecedented functional cure rates with potential to redefine treatment for chronic hepatitis B ionis.com ↗
Pivotal B-Well data show significant 19% functional cure rate in the overall study population and 26% in patients with lower viral activity, compared to 0% with standard of care |
| 2026-04-28 | GlaxoSmithKline | Regulatory Bepirovirsen accepted for priority review and granted Breakthrough Therapy Designation by the US FDA gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted for priority review a New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO), for the treatment of adults with chronic hepatitis B (CHB). |
| 2026-04-28 | Ionis Pharmaceuticals | Regulatory Ionis partner GSK announces bepirovirsen accepted for Priority Review and granted Breakthrough Therapy Designation by U.S. FDA as a potential first-in-class medicine for chronic hepatitis B ionis.com ↗
The FDA has granted bepirovirsen Breakthrough Therapy designation and set a Prescription Drug User Fee Act (PDUFA) target action date of October 26, 2026. |
| 2026-03-30 | GlaxoSmithKline | Regulatory Bepirovirsen accepted for regulatory review in China as a potential first-in-class functional cure for chronic hepatitis B gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration (NMPA) has accepted for review a new drug application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO), for the treatment of adults with chronic hepatitis B (CHB). |
| 2026-03-27 | GlaxoSmithKline | Regulatory Bepirovirsen accepted for review by the European Medicines Agency as a potential first-in-class treatment for chronic hepatitis B gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) for the use of bepirovirsen, an investigational antisense oligonucleotide (ASO), in the treatment of adults with chronic hepatitis B (CHB). |
| 2026-02-26 | GlaxoSmithKline | Regulatory Bepirovirsen accepted for regulatory review in Japan as a potential first-in-class treatment for chronic hepatitis B gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a new drug application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO), for the treatment of adults with chronic hepatitis B (CHB). |
| 2026-01-07 | GlaxoSmithKline | Results GSK announces positive results from B-Well 1 and B-Well 2 phase III trials for bepirovirsen, a potential first-in-class treatment for chronic hepatitis B gsk.com ↗
The B-Well trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. |
| 2026-01-07 | Ionis Pharmaceuticals | Results Ionis partner GSK announces positive topline results from B-Well 1 and B-Well 2 Phase 3 studies for bepirovirsen, a potential first-in-class medicine for chronic hepatitis B ionis.com ↗
The B-Well studies met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. |
| 2025-11-07 | GlaxoSmithKline | Results GSK presents data from its advancing liver pipeline at AASLD 2025 gsk.com ↗
Phase II B-Sure study sub-analysis shows durability of functional cure in chronic hepatitis B (CHB) patients treated with bepirovirsen and pegylated interferon (Peg-IFN) |
| 2024-11-13 | GlaxoSmithKline | Results GSK highlights key data from hepatology portfolio at the AASLD’s The Liver Meeting® 2024, emphasising patient impact in areas of high unmet need gsk.com ↗
Simulation results show that added benefit of sequential daplusiran/tomligisiran followed by bepirovirsen versus bepirovirsen alone plus nucleos(t)ide analogs (NAs), could further increase functional cure rates in CHB. |
| 2024-08-28 | GlaxoSmithKline | Regulatory Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SENKU (formerly known as SAKIGAKE) designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). |
| 2024-02-12 | GlaxoSmithKline | Regulatory GSK receives US FDA Fast Track designation for bepirovirsen in chronic hepatitis B gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). |
| 2023-10-11 | GlaxoSmithKline | Results GSK presents scientific advances to improve patient outcomes at the American Association for the Study of Liver Diseases’ The Liver Meeting® 2023 gsk.com ↗
New data from the B-Together phase IIb trial assessing the potential of a sequential treatment regimen of bepirovirsen followed by pegylated interferon alpha reflect contribution to the development of a functional cure for people living with chronic hepatitis B (CHB) |
| 2022-11-08 | GlaxoSmithKline | Results Positive data for bepirovirsen from B-Clear phase IIb trial presented at American Association for the Study of Liver Diseases’ Meeting with simultaneous publication in the New England Journal of Medicine gsk.com ↗
The results showed that treatment with bepirovirsen, an investigational antisense oligonucleotide treatment, resulted in sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA both in patients on concurrent nucleoside/nucleotide analogues (NA) and patients not-on-NA therapy. |
| 2022-11-08 | Ionis Pharmaceuticals | Results Ionis announces positive data from GSK's Phase 2b clinical study of bepirovirsen ionis.com ↗
The results showed that treatment with bepirovirsen resulted in sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA for 24 weeks after end of bepirovirsen treatment in people with CHB. |
| 2022-06-25 | GlaxoSmithKline | Results GSK presents promising new data for bepirovirsen, an investigational treatment for chronic hepatitis B gsk.com ↗
Interim analysis from the B-Clear phase IIb trial shows bepirovirsen’s potential to suppress both the surface antigen and the virus of hepatitis B, leading to the possibility of functional cure |
| 2022-06-25 | Ionis Pharmaceuticals | Results Ionis announces presentation of positive Phase 2b data for chronic hepatitis B treatment at the EASL International Liver Congress™ ionis.com ↗
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), today announced that GSK presented positive results from an interim analysis of the Phase 2b B-Clear clinical study of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B virus (CHB). |
| 2020-08-28 | GlaxoSmithKline | Results GSK presents promising phase 2a data for chronic hepatitis B treatment gsk.com ↗
We have observed promising early-stage results showing antiviral activity with our anti-sense oligonucleotide, a key investigational medicine in our growing infectious diseases portfolio. |
All press releases naming this drug 24 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bepirovirsen | “Bepirovirsen (GSK3228836) is an antisense oligonucleotide that induced rapid and prolonged hepatitis B surface antigen (HBsAg) reduction with a favorable safety profile...” PMID 37393402 ↗ Jul 202311“Bepirovirsen is an antisense oligonucleotide currently in Phase 3 development to treat chronic hepatitis B virus (HBV) infection.” PMID 39950613 ↗ Feb 2025 |
| Known as | GSK-3228836B | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650468 ↗ |
| Known as | GSK3228836 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04676724 ↗ |
| Known as | IONIS HBVRX | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650468 ↗ |
| Known as | ISIS 505358 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650468 ↗ |
| Known as | ISIS-GSK3RX | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650468 ↗ |
| Action | Inhibit | “bepirovirsen leads to reductions in HBV-derived RNAs” PMID 34642494 ↗ Oct 2021 |
| Modality | Antisense oligonucleotide | “Bepirovirsen is an antisense oligonucleotide” PMID 39950613 ↗ Feb 2025 |
| Route | Subcutaneous | “administered subcutaneously” NCT02981602 ↗ |