AstraZeneca: Baxdrostat Phase 3 results posted, Saphnelo label updated, new China lupus trial

AstraZeneca had a busy week spanning posted trial results, a label update, and new study registrations.

• Results were posted for the Phase 3 "Bax24" trial (NCT06168409) testing baxdrostat, also known as CIN-107, against placebo in participants with resistant hypertension. The study had an enrollment of 218 participants (actual).¹ The trial's primary completion date was 2025-08-17¹ and results were first posted 2026-08-06.
• The FDA approved a labeling supplement (SUPPL 12) for Saphnelo, an injectable formulation of anifrolumab-fnia, sponsored by AstraZeneca AB², with the new label dated 2026-08-11.
• A new Phase 3b trial, "LOTUS" (NCT07751848), is recruiting to evaluate anifrolumab in Chinese patients with active moderate to severe systemic lupus erythematosus. The study is enrolling 417 participants (estimated)³ and its primary outcome is the proportion of patients who achieve DORIS remission at week 52.³
• A new observational registry, VERITAS (NCT07743944), aims to track treatment patterns and outcomes for HR+/HER2-negative metastatic breast cancer patients in China, including HER2-low, HER2-ultralow, and HER2-null⁴ subtypes. The study has an estimated enrollment of 2000 participants⁴ and is set to begin 2026-08-05.
• AstraZeneca is a collaborator, not lead sponsor, on the EMERALD observational study (NCT07745933), led by FADOI (Italian Society of Hospital Internal Medicine) in collaboration with AIGO, AII-ISA, and SIMEU⁵. The study, which is collecting data on patients experiencing major bleeding while on oral factor Xa inhibitors, is listed as active, not recruiting, with an enrollment of 503 participants (actual).⁵