--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Generic, brand name and therapeutic class of product" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Generic, brand name and therapeutic class of product. Topics: Generic and brand name, Manufacturer: GSK, Developer: Ionis Pharmaceuticals, Development codes and former names, and 4 further topics. 8 evidence topics quoted from 8 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description/generic-brand-name-and-therapeutic-class-of-product" published: "2026-10-21T22:39:04-04:00" modified: "2026-10-22T19:07:03-04:00" --- # Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Generic, brand name and therapeutic class of product ## 2.1.2.1 Generic, Brand Name and Therapeutic Class of Product ### Generic and brand name > “HIBSAGO (bepirovirsen) injection, for subcutaneous use” > “Active ingredient: bepirovirsen sodium” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) > “The drug will now carry the commercial moniker Hibsago” Source: [Fierce Pharma (2026)](https://www.fiercepharma.com/pharma/gsk-brings-promise-functional-cure-hepatitis-b-finish-line-fda-nod-hibsago) ### Manufacturer: GSK > “The approval was granted to GSK plc.” Source: [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment) > “GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection” Source: [GSK press release, Hibsago US approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/) > “Trademarks are owned by or licensed to the GSK group of companies.” > “Manufactured for” > “GlaxoSmithKline” > “Durham, NC 27701” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Developer: Ionis Pharmaceuticals > “Bepirovirsen (previously known as ‘ISIS 505358 or IONIS-HBVRX’) was discovered by and jointly developed with Ionis Pharmaceuticals.” > “Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019.” Source: [GSK press release, Fast Track designation (2024)](https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b/) > “GSK licensed bepirovirsen from Ionis and collaborated with them on its development.” Source: [Ionis press release, Hibsago US approval (2026)](https://ir.ionis.com/news-releases/news-release-details/ionis-partner-gsk-announces-hibsago-bepirovirsen-approved-us) ### Development codes and former names > “Bepirovirsen (formerly known as IONIS-HBVRx), also known as GSK3228836, is an investigational antisense medicine designed to reduce the production of viral proteins associated with hepatitis B virus (HBV) infection and replication” Source: [Ionis press release, phase 3 start (2023)](https://ir.ionis.com/node/29351) ### Therapeutic class: first antisense oligonucleotide approved for chronic hepatitis B > “Hibsago is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B.” > “Hibsago works by targeting the genetic instructions the virus uses to make copies of itself and viral proteins, helping reduce the amount of virus and hepatitis B surface antigen in the body.” Source: [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment) ### Therapeutic class: company descriptions at approval > “Bepirovirsen is a first in class antisense oligonucleotide (ASO) and offers unprecedented functional cure rates compared to current standard of care.” Source: [GSK press release, Hibsago US approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/) > “Bepirovirsen is a non-GalNAc-conjugated antisense oligonucleotide (ASO) designed to recognize and inhibit the production of the genetic components (i.e., RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control.” Source: [Ionis press release, Hibsago US approval (2026)](https://ir.ionis.com/news-releases/news-release-details/ionis-partner-gsk-announces-hibsago-bepirovirsen-approved-us) ### Chemical class: 2′-O-(2-methoxyethyl) gapmer antisense oligonucleotide > “Bepirovirsen is a synthetic, single-stranded, chimeric antisense oligonucleotide (ASO) with a gapmer architecture consisting of five 2′-O-(2-methoxyethyl) (2′-MOE)-modified ribonucleotide wings flanking a central 10-deoxynucleotide gap with phosphorothioate linkages throughout.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Chemical description: salt form, molecular formula, and molecular weight > “The molecular formula of bepirovirsen sodium is C230H290N88Na19O115P19S19 and its molecular weight is 7761.9.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) | Field | Quoted record | | --- | --- | | Name | “Bepirovirsen sodium (JAN/USAN)” | | Trade name | “Hibsago (TN)” | | CAS number | “2563929-84-8” | Source: [KEGG DRUG D12615](https://www.kegg.jp/entry/D12615) ## Related pages - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Terms and abbreviations](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations.md) - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Product information and disease description](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Clinical evidence](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: new drug review](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: cost-effectiveness analyses and utility weights](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses.md)