AKB-9090 is being studied as a potential acute-care therapy for patients at risk of kidney injury following cardiac procedures—a setting where AKI remains common and is associated with increased morbidity, mortality, and healthcare costs. While HIF-PH inhibitors are already used in chronic kidney disease, AKB-9090 is designed for short-term, inpatient use during acute renal stress, such as the perioperative period.

The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled study incorporating both single-ascending dose (SAD) and multiple-ascending dose (MAD) cohorts. Up to 70 healthy adult participants are expected to be enrolled. The primary objectives are to assess safety and tolerability, along with pharmacokinetics and pharmacodynamic responses following intravenous administration. Key measures include adverse event rates and changes in laboratory values, vital signs, and electrocardiographic findings.

Akebia executives highlighted that the program builds on the company’s long-standing expertise in HIF-PH biology and reflects a broader strategy to expand into acute kidney injury, an area with limited therapeutic options. Top-line results from the Phase 1 study are expected in early 2027.

The AKB-9090 trial is part of Akebia’s expanding renal-focused pipeline, which was formally outlined in late 2025. Other assets in development include praliciguat, a soluble guanylate cyclase stimulator undergoing Phase 2 evaluation for focal segmental glomerulosclerosis, and AKB-097, a next-generation complement inhibitor planned to enter a Phase 2 basket trial in rare kidney diseases, such as IgA nephropathy, lupus nephritis, and C3 glomerulopathy, in the second half of 2026.

Together, these programs underscore Akebia’s continued emphasis on both chronic and acute kidney disorders with high unmet medical need.