GSK's Benlysta label updated by FDA; Phase 2a NASH trial posts results

The week of October 26, 2026 brought an FDA label update for GlaxoSmithKline's Benlysta along with a cluster of trial registry changes spanning GSK-sponsored and collaborator studies.

• GSK's Benlysta (belimumab) received an FDA-approved labeling supplement across both of its biologics license applications, BLA761043 and BLA125370, with the submission status dated 2026-10-30 and marked as approved¹, covering the injectable 200MG/ML formulation and the 400MG and 120MG injectable strengths, respectively.
• A completed Phase 2a trial of GSK4532990 in participants with NASH or suspected NASH, called SKYLINE, posted results. The study, which enrolled 61 participants² and finished in September 2025, measured liver biopsy-derived HSD17B13 protein expression and reported percent changes from baseline ranging from -57.27 at the 25 mg dose to -88.79 at the 800 mg dose².
• A Phase 1b GSK trial called PEGASUS is recruiting participants with moderate to severe ulcerative colitis to test aletekitug (GSK1070806), an anti-IL-18 biologic, in a study enrolling an estimated 8 participants³.
• A Phase 1 GSK trial comparing vial versus autoinjector delivery of bepirovirsen in healthy adults is not yet recruiting, with an estimated enrollment of 98 participants⁴ and a planned start of November 3, 2026.
• GSK is a collaborator, with the Hellenic Cooperative Oncology Group as sponsor, on an observational study using whole-exome and RNA sequencing to find prognostic biomarkers in non-small cell lung cancer, recruiting an estimated 300 patients with histologically confirmed NSCLC⁵.
• GSK is also a collaborator, with the Austrian Breast & Colorectal Cancer Study Group as lead sponsor, on a recruiting observational rectal cancer registry in Austria expected to enroll about 600 participants, both retrospective and prospective, across approximately 6 study sites⁶.
• A Wake Forest University Health Sciences-sponsored Phase I/II trial combining carfilzomib, lenalidomide, dexamethasone and belantamab mafodotin in multiple myeloma, with GSK and Amgen as collaborators, remains recruiting with an estimated enrollment of 70 participants⁷.
• A University of North Carolina at Chapel Hill-sponsored Phase 4 pilot study of field-based long-acting cabotegravir/rilpivirine for people with HIV who are out of care, with ViiV Healthcare as a collaborator, is not yet recruiting and plans to enroll 40 adult men and women living with HIV⁸.