Akebia Therapeutics Doses First Patients in 70-Participant Phase I AKB-9090 Trial
Akebia Therapeutics has dosed first participants in a Phase 1 randomized, double-blind, placebo-controlled trial of AKB-9090, its internally developed HIF-PH inhibitor for cardiac surgery–associated acute kidney injury, enrolling up to 70 adults. The SAD/MAD study aims to assess safety, tolerability, PK/PD and deliver top-line data in early 2027.
1. Phase 1 Trial Launch
On April 13, Akebia Therapeutics initiated dosing of the first healthy adult participants in its Phase 1 study of AKB-9090, targeting cardiac surgery-associated acute kidney injury. This milestone advances the company’s internally developed HIF-PH inhibitor into clinical evaluation.
2. Study Design and Endpoints
The randomized, double-blind, placebo-controlled single and multiple ascending dose (SAD/MAD) trial will enroll up to 70 participants across sequential cohorts. Primary endpoints include incidence of treatment-emergent adverse events, changes in laboratory parameters, vital signs and electrocardiograms, as well as pharmacokinetic and pharmacodynamic profiling.
3. Broader Pipeline Context
In late 2025 Akebia unveiled its clinical-stage kidney disease portfolio, including praliciguat in a Phase 2 focal segmental glomerulosclerosis trial and AKB-097, a tissue-targeted complement inhibitor expected to enter a Phase 2 basket study in IgA nephropathy, lupus nephritis and C3 glomerulopathy in the second half of 2026.