Akebia Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of therapeutics for patients with kidney diseases. The firm is also involved in the development and commercialization of drugs for the treatment of renal and metabolic disorders. Its products include Auryxia and Vadadustat. The company was founded by Joseph H. Gardner, John M. Rice, Michael E. Pape, Josh P. Fairbank, and Robert A. Shalwitz on February 27, 2007 and is headquartered in Cambridge, MA.
Clinical Trials
65
28 active
Approvals
3
Total approvals
Agencies
1
Regulatory bodies
Founded
2007
Active, not recruiting
28
43.1%
Completed
30
46.1%
Recruiting
3
4.6%
Terminated
1
1.5%
Withdrawn
3
4.6%
- Akebia Therapeutics has dosed the first patient in an open-label Phase 2 basket trial of ebribafusp in IgA nephropathy, lupus nephritis and C3 glomerulopathy. - The trial will enroll up to 30 patients who receive once-weekly subcutaneous ebribafusp for 26 weeks, followed by a long-term extension for responders. - The primary endpoint is adverse event incidence, with secondary endpoints including proteinuria by UPCR, kidney function by eGFR and pharmacokinetics. - Ebribafusp is an anti-C3d factor H fusion protein designed to inhibit complement activation in kidney tissue without suppressing complement in the blood, with initial data expected in 2027.
- Akebia Therapeutics has dosed the first patient in an open-label Phase 2 basket trial of ebribafusp in IgA nephropathy, lupus nephritis and C3 glomerulopathy. - Ebribafusp is an anti-C3d factor H fusion protein designed to inhibit complement activation in kidney tissue without suppressing the complement system in the blood. - The trial will enroll up to 30 patients receiving once-weekly subcutaneous dosing for 26 weeks, with initial data expected in 2027. - Akebia acquired global rights to ebribafusp from Q32 Bio in November 2025, following nonclinical studies and a completed Phase 1 trial in healthy volunteers.
- Akebia Therapeutics has dosed the first participants in a Phase 1 clinical trial of AKB-9090, a hypoxia-inducible factor-prolyl hydroxylase inhibitor for treating cardiac surgery-associated acute kidney injury. - The randomized, double-blind, placebo-controlled study will enroll up to 70 healthy participants to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous AKB-9090. - The company plans to report top-line data from the Phase 1 trial in early 2027, marking progress in addressing acute care conditions with significant unmet medical need. - AKB-9090 represents one of three clinical-stage kidney disease programs in Akebia's pipeline, alongside praliciguat and AKB-097 targeting various nephrology conditions.
- Q32 Bio completed enrollment of 33 patients in Part B of the SIGNAL-AA Phase 2a trial evaluating bempikibart for severe alopecia areata, with 36-week topline data expected in mid-2026. - The company achieved steady-state drug concentrations nine weeks earlier than in Part A due to an optimized loading regimen, potentially enabling earlier clinical responsiveness. - Q32 Bio secured financial runway through Q4 2027 via a $10.5 million registered direct offering and the strategic sale of ADX-097 to Akebia Therapeutics for $12 million upfront. - The FDA granted Fast Track designation for bempikibart in alopecia areata to expedite development and regulatory review processes.
- Akebia Therapeutics has dosed the first patient in a Phase 2 clinical trial evaluating praliciguat, an oral soluble guanylate cyclase stimulator, for treating focal segmental glomerulosclerosis (FSGS). - The randomized, double-blind, placebo-controlled study will enroll approximately 60 patients with biopsy-confirmed FSGS to assess changes in urine protein-to-creatinine ratio over 24 weeks. - FSGS affects approximately 40,000 patients in the U.S. with no currently approved treatments, representing a significant unmet medical need. - Praliciguat has demonstrated no significant safety issues in previous Phase 1 studies in healthy volunteers and Phase 2 studies in heart failure and diabetic kidney disease.
- Akebia Therapeutics acquired AKB-097, a tissue-targeted complement inhibitor from Q32 Bio for $7 million upfront, designed to address multiple rare kidney diseases without systemic complement inhibition. - The company initiated a Phase 2 trial of praliciguat, an oral sGC stimulator, in focal segmental glomerulosclerosis (FSGS), targeting up to 60 patients with primary endpoint of proteinuria reduction. - Both therapeutic programs are planned to begin patient enrollment in 2026, with AKB-097 Phase 2 basket trial data expected in 2027. - FSGS affects approximately 40,000 people in the U.S. with no specific treatments currently available, representing a significant unmet medical need.
- Akebia Therapeutics has decided not to initiate the VALOR clinical trial for Vafseo in non-dialysis chronic kidney disease patients after failing to reach alignment with the FDA on study design. - The FDA indicated that regulatory approval would require a significantly larger patient population than Akebia proposed, leading to substantially increased time and costs for the trial. - The company will focus on making Vafseo the standard of care for dialysis patients while exploring potential trials in smaller CKD patient subgroups. - Vafseo is currently approved in the U.S. for treating anemia in adults with chronic kidney disease who have been on dialysis for at least three months.
- Vor Bio has appointed Dr. Qing Zuraw as Chief Development Officer, bringing over 25 years of experience in autoimmune disease clinical development. - Dr. Zuraw previously led telitacicept development at RemeGen across four indications, achieving regulatory approvals in China for SLE, generalized myasthenia gravis, and rheumatoid arthritis. - The appointment positions Vor Bio to advance telitacicept through Phase 3 clinical development and global commercialization for autoantibody-driven conditions. - Dr. Zuraw secured multiple FDA designations for telitacicept including Fast Track, Breakthrough Therapy, and Orphan Drug status across various indications.
- Avalo Therapeutics has appointed Rita Jain, M.D., a rheumatologist with over two decades of biopharmaceutical leadership experience, to its Board of Directors. - The appointment comes as the company advances AVTX-009, a high-affinity anti-IL-1β monoclonal antibody, through a Phase 2 LOTUS trial for hidradenitis suppurativa. - Dr. Jain previously served as Chief Medical Officer at ChemoCentryx, where she advanced Tavneos (avacopan), a first-in-class treatment for ANCA-associated vasculitis. - The Phase 2 LOTUS trial results for hidradenitis suppurativa are expected to read out in the middle of next year.
- The Journal of the American Society of Nephrology published pre-specified analyses from vadadustat's global phase 3 program, comparing U.S. and non-U.S. patient outcomes in chronic kidney disease-related anemia treatment. - Among dialysis-dependent CKD patients, vadadustat showed similar safety and efficacy to darbepoetin alfa both within and outside the United States. - For non-dialysis-dependent CKD patients in the U.S. subgroup, vadadustat demonstrated higher cardiovascular risk compared to darbepoetin alfa when used outside the United States. - The analyses highlight how regional differences in patient characteristics, hemoglobin targets, and healthcare practices can influence treatment outcomes in global clinical trials.
