CAMBRIDGE, Mass., April 13, 2026
Akebia Therapeutics, Inc., a biopharmaceutical company focused on kidney disease, has announced that the first participants have been successfully dosed in a Phase 1 clinical trial of AKB-9090, marking a critical milestone in the development of a potential treatment for cardiac surgery-associated acute kidney injury (AKI). This advancement reflects the company’s continued commitment to addressing high unmet medical needs in acute and chronic kidney disorders, while expanding its pipeline of innovative therapeutic candidates.
Phase 1 Trial Targets Acute Kidney Injury Innovation
The Phase 1 clinical trial of AKB-9090 is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational drug. The study will enroll up to 70 healthy adult participants, who will receive either AKB-9090 or placebo across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
AKB-9090 is an internally developed hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, a class of compounds that modulate cellular responses to low oxygen conditions. This mechanism has shown promise in addressing tissue damage and inflammation associated with acute kidney injury, particularly in patients undergoing complex cardiac surgeries.
The initiation of dosing represents a key step in validating the safety profile of AKB-9090 and advancing its clinical development pathway, with topline data expected in early 2027. Acute kidney injury remains a significant complication in cardiac surgery, often leading to prolonged hospital stays and increased mortality, underscoring the importance of innovative therapeutic approaches.
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Expanding Pipeline Strengthens Kidney Disease Focus
The development of AKB-9090 is part of Akebia’s broader strategy to build a diversified pipeline targeting multiple kidney disease indications. In addition to this program, the company is advancing praliciguat, currently in a Phase 2 clinical trial for focal segmental glomerulosclerosis (FSGS), and AKB-097, a next-generation tissue-targeted complement inhibitor expected to enter Phase 2 studies in rare kidney diseases such as IgA nephropathy and lupus nephritis.
This multi-asset approach highlights Akebia’s focus on both acute care and chronic kidney conditions, positioning the company to address a wide spectrum of patient needs. By leveraging deep expertise in renal biology and hypoxia signaling pathways, Akebia aims to deliver differentiated therapies that improve clinical outcomes and reduce disease burden.
The company’s pipeline expansion also reflects a broader industry trend toward precision medicine and targeted therapies, where treatments are designed to address specific biological mechanisms underlying disease progression.
Addressing Unmet Needs in Acute Care and Beyond
Acute kidney injury, particularly in the context of cardiac surgery, represents a critical unmet medical need with limited effective treatment options. Current management strategies are largely supportive, emphasizing the urgent need for disease-modifying therapies that can prevent or mitigate kidney damage.
AKB-9090’s mechanism of action offers the potential to enhance oxygen delivery pathways and protect renal tissue during periods of physiological stress, which could translate into improved patient outcomes. If successful, the therapy could redefine the standard of care for AKI and significantly reduce complications associated with major surgical procedures.
Company leadership emphasized that the initiation of the Phase 1 trial reflects confidence in the scientific foundation of AKB-9090 and its potential to address acute care conditions. The program builds on Akebia’s established expertise in HIF biology, which has already been successfully applied in other therapeutic areas.
With the first patients now dosed and a clear clinical roadmap ahead, Akebia Therapeutics is advancing a promising candidate that could transform the treatment landscape for acute kidney injury. As the study progresses, the results will be closely watched by clinicians, researchers, and stakeholders seeking innovative solutions for one of the most challenging complications in modern healthcare.
Source: Akebia Therapeutics press release
