Akebia Therapeutics announced that the first participants have been dosed in a Phase 1 clinical trial of its internally developed hypoxia‑inducible factor‑prolyl hydroxylase inhibitor, AKB‑9090. The randomized, double‑blind, placebo‑controlled study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adults.
The trial will enroll up to 70 participants across single‑ and multiple‑dose cohorts and will assess treatment‑emergent adverse events, laboratory parameters, vital signs and electrocardiograms. AKB‑9090 is being developed to prevent acute kidney injury that can occur after cardiac surgery, a condition that currently has no approved therapies and represents a significant unmet medical need.
This first‑in‑human exposure marks a key step toward regulatory approval. Akebia plans to report top‑line data in early 2027, and the program will advance alongside other pipeline assets such as the sGC stimulator praliciguat and the complement inhibitor AKB‑097.
Akebia’s commercial portfolio includes the HIF‑PH inhibitor Vafseo for anemia in dialysis patients and the iron‑citrate Auryxia for phosphorus control in chronic kidney disease. In 2025, Vafseo generated $12.0 million in net product revenues, while Auryxia sales are expected to decline in 2026 due to generic competition. The company’s cash position of $113.4 million as of March 31 2025 is expected to fund operations for at least two years.
Management emphasized the strategic importance of AKB‑9090. CEO John P. Butler said, "AKB‑9090 has been internally developed leveraging our team's extensive expertise in HIF‑PH biology, and we believe is a promising product candidate with the potential to treat acute care conditions with significant unmet need such as AKI." He added, "We are pleased to have dosed our first study participants in the Phase 1 clinical trial and plan to report top‑line data in early 2027."
AKB‑9090 represents a diversification of Akebia’s pipeline beyond HIF‑PH inhibitors, providing a potential revenue source as Vafseo’s patent protection wanes and Auryxia faces generic competition. The successful initiation of the trial therefore strengthens Akebia’s long‑term growth prospects and positions the company to address a high‑impact, high‑cost medical condition that lacks effective treatments.
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