Hibsago

Treats chronic hepatitis B virus (HBV) infection. NDA 221276, held by Glaxosmithkline LLC. Bepirovirsen.

As of Nov 14, 2026, NDA 221276 (Hibsago), held by Glaxosmithkline LLC, was first approved by FDA on Oct 20, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2026
Review: Priority
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

HIBSAGO is indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis:

who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA)
who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Oct 20, 2026	Original applicationNew molecular entity · Priority review	Approved	Label Medication Guide Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hibsagoinjection;solution	Bepirovirsen	Rx

Identifiers

Application: NDA 221276
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters