--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Phase of product development" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Phase of product development. Topics: Regulatory status: Approved; NDA submitted in the first quarter of 2026 and approved October 2026, Launch: Anticipated before the end of 2026, FDA approval on 20 October 2026, Expedited programs named at approval, and 14 further topics. 18 evidence topics quoted from 20 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description/phase-of-product-development" 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: Phase of product development ## 2.1.1 Phase of Product Development ### Regulatory status: Approved; NDA submitted in the first quarter of 2026 and approved October 2026 > “In Q1, the US FDA accepted for priority review a New Drug Application (NDA) for bepirovirsen and set 26 October 2026 as the decision goal date.” > “lower spend on bepirovirsen which was filed in the quarter” Source: [GSK Q1 2026 results (2026)](https://www.gsk.com/media/hpgfxwxv/q1-2026-results-announcement.pdf) > “Growth was partly offset by lower spend on bepirovirsen which was filed in Q1 2026.” Source: [GSK Q2 2026 results (2026)](https://www.gsk.com/media/jayh41pz/q2-2026-results-announcement.pdf) | Field | Quoted record | | --- | --- | | Drug name | “Hibsago” | | Active ingredient | “bepirovirsen” | | Approval date | “10/20/2026” | Source: [FDA Novel Drug Approvals for 2026 (2026)](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026) ### Launch: Anticipated before the end of 2026 > “Hibsago should be made available to U.S. patients before the end of the year, a GSK spokesperson told Fierce” Source: [Fierce Pharma (2026)](https://www.fiercepharma.com/pharma/gsk-brings-promise-functional-cure-hepatitis-b-finish-line-fda-nod-hibsago) > “GSK anticipates the first regulatory decisions in Q3 2026 and launch preparations are underway.” Source: [GSK press release, B-Well results (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-achieves-unprecedented-functional-cure-rates-with-potential-to-redefine-treatment-for-chronic-hepatitis-b/) ### FDA approval on 20 October 2026 > “The U.S. Food and Drug Administration today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.” Source: [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment) > “Initial U.S. Approval: 2026” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Expedited programs named at approval > “The FDA granted Hibsago Fast Track and Breakthrough Therapy designations as well as Priority Review.” Source: [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment) > “The approval was granted under FDA priority review and Breakthrough Therapy Designation, recognising significant improvement of bepirovirsen and nucleos(t)ide analogue therapy over existing 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/) ### Evidence supporting approval > “Researchers studied Hibsago in two clinical trials that compared it with a placebo, an inactive treatment.” > “Across the two trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received placebo.” Source: [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment) > “The approval was supported by results from the B-WELL phase III trials showing functional cure rates of 19% in adults with ≤3000 IU/ml HBsAg, compared to current standard of care alone, which typically achieves less than 1% functional cure rate after one year of treatment.” 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/) ### Priority review and PDUFA goal date, April 2026 > “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).” > “The FDA has assigned 26 October 2026 as the Prescription Drug User Fee Act (PDUFA) goal date.” Source: [GSK press release, FDA priority review (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/) > “Regulatory review is ongoing in the US with a decision expected from the FDA by 26 October 2026.” Source: [GSK Q2 2026 results (2026)](https://www.gsk.com/media/jayh41pz/q2-2026-results-announcement.pdf) ### Breakthrough therapy designation, first quarter of 2026 > “Bepirovirsen has also received Breakthrough Therapy Designation (BTD), which is reserved for investigational medicines where preliminary clinical evidence indicates the potential for substantial improvement over available therapies.” > “The BTD for bepirovirsen builds on the Fast Track Designation also provided by the US FDA in February 2024.” Source: [GSK press release, FDA priority review (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/) > “In Q1, bepirovirsen also received FDA Breakthrough Therapy Designation which is reserved for investigational medicines where preliminary clinical evidence indicates the potential for substantial improvement over available therapies.” Source: [GSK Q1 2026 results (2026)](https://www.gsk.com/media/hpgfxwxv/q1-2026-results-announcement.pdf) ### Fast track designation, February 2024 > “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).” > “Data from the phase IIb trials B-Clear and B-Sure, which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB, were submitted in support of the application.” 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/) ### Phase 3 B-Well trials: initiation in February 2023 > “Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase 3 studies evaluating the safety and efficacy of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection (CHB).” > “Ionis earned a $15 million milestone payment from GSK associated with the progression of bepirovirsen into the Phase 3 clinical studies.” Source: [Ionis press release, phase 3 start (2023)](https://ir.ionis.com/node/29351) ### Phase 3 B-Well trials: topline results in January 2026 > “Primary endpoint met in both trials” > “Global regulatory filings planned from Q1 2026” Source: [GSK press release, B-Well topline (2026)](https://www.gsk.com/en-gb/media/press-releases/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/) ### Japan: application accepted in February 2026 > “First regulatory filing globally, with SENKU designation enabling expedited review” > “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).” Source: [GSK press release, Japan acceptance (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-regulatory-review-in-japan/) ### Japan: SENKU designation, August 2024 > “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).” > “The goal of SENKU designation is to increase early patient access to innovative medicines through an expedited review process to treat serious conditions and fill an unmet medical need.” Source: [GSK press release, SENKU designation (2024)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-granted-senku-designation-in-japan-for-chronic-hepatitis-b/) ### Japan: approval on 24 August 2026 > “First global approval for Hibsago” > “This is the first global approval for bepirovirsen, and the first and only functional cure treatment for CHB approved in Japan.” > “This approval was accelerated by SENKU designation, granted to innovative medicines with potential to address high unmet medical need.” Source: [GSK press release, Hibsago Japan approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-japan-as-first-and-only-functional-cure-for-chronic-hepatitis-b/) ### European Union: marketing authorisation application accepted in March 2026 > “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).” Source: [GSK press release, EMA acceptance (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-review-by-the-european-medicines-agency-as-a-potential-first-in-class-treatment-for-chronic-hepatitis-b/) ### China: application accepted in March 2026 > “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).” Source: [GSK press release, China acceptance (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-regulatory-review-in-china-as-a-potential-first-in-class-functional-cure-for-chronic-hepatitis-b/) ### China: breakthrough therapy designation in August 2021 and priority review in April 2026 > “Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021 and accepted for Priority Review in April 2026.” Source: [GSK press release, SBP Group collaboration (2026)](https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-collaboration-with-sbp-group-a-market-leader-in-hepatology-in-china-to-accelerate-bepirovirsen-at-launch/) ### Anticipated regulatory decisions outside the United States > “Reviews are also underway in Japan, China and the EU with further submissions to take place throughout 2026.” Source: [GSK Q2 2026 results (2026)](https://www.gsk.com/media/jayh41pz/q2-2026-results-announcement.pdf) | Anticipated pipeline milestone | Event | Timing | | --- | --- | --- | | United States and Japan | “Regulatory decision (US, JP)” | “H2 2026” | | European Union and China | “Regulatory decision (EU, CN)” | “H1 2027” | Source: [GSK Q2 2026 results (2026)](https://www.gsk.com/media/jayh41pz/q2-2026-results-announcement.pdf) > “GSK continues to advance regulatory submissions for bepirovirsen across multiple geographies with key regulatory decisions anticipated in the coming months.” > “Bepirovirsen is approved in Japan and the US.” 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/) ### Licensing from Ionis Pharmaceuticals, August 2019 > “Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in RNA-targeted therapeutics, announced today that GSK exercised its option to license Ionis' antisense medicines for people with chronic hepatitis B virus (CHB) infection following positive Phase 2 results.” > “As a part of the licensing agreement, Ionis is eligible to receive license fees and milestone payments up to $262 million, including a $25 million license fee.” > “GSK is now responsible for all development, regulatory and commercialization activities and costs.” Source: [Ionis press release, GSK license (2019)](https://ir.ionis.com/node/25196) > “GSK licensed bepirovirsen from Ionis in 2019 under a collaborative development and licensing agreement.” 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) ## 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)