Akebia Therapeutics
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2007-01-01
- Employees
- 167
- Market Cap
- $319.6M
- Website
- http://www.akebia.com
- Introduction
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
62
Trial Phases
3 Phases
Drug Approvals
1
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (62 trials with phase data)• Click on a phase to view related trials
To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
- Conditions
- Anemia of Chronic Kidney Disease
- Interventions
- Drug: Erythropoiesis-Stimulating Agent (ESA)
- First Posted Date
- 2025-03-30
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- Akebia Therapeutics
- Target Recruit Count
- 500
- Registration Number
- NCT06901505
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
- First Posted Date
- 2021-10-19
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- Akebia Therapeutics
- Target Recruit Count
- 71
- Registration Number
- NCT05082584
- Locations
- 🇺🇸
Research Site, Hackensack, New Jersey, United States
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
- First Posted Date
- 2021-10-19
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- Akebia Therapeutics
- Target Recruit Count
- 71
- Registration Number
- NCT05082571
- Locations
- 🇺🇸
Research Site, Hackensack, New Jersey, United States
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
- Conditions
- Anemia Associated With Chronic Kidney Disease (CKD)
- Interventions
- First Posted Date
- 2021-01-13
- Last Posted Date
- 2025-01-15
- Lead Sponsor
- Akebia Therapeutics
- Target Recruit Count
- 456
- Registration Number
- NCT04707768
- Locations
- 🇺🇸
Research Site, Woodbridge, Virginia, United States
🇺🇸Research Site#1, Coral Springs, Florida, United States
🇺🇸Research Site#2, Coral Springs, Florida, United States
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
- First Posted Date
- 2021-01-13
- Last Posted Date
- 2022-06-28
- Lead Sponsor
- Akebia Therapeutics
- Target Recruit Count
- 22
- Registration Number
- NCT04707573
- Locations
- 🇺🇸
Research Site, Knoxville, Tennessee, United States
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News
Avalo Therapeutics Appoints Rita Jain to Board as AVTX-009 Phase 2 Trial for Hidradenitis Suppurativa Progresses
Avalo Therapeutics has appointed Rita Jain, M.D., a rheumatologist with over two decades of biopharmaceutical leadership experience, to its Board of Directors.
Vadadustat Phase 3 Data Reveals Geographic Differences in CKD Anemia Treatment Outcomes
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.
PeptiSystems and Asahi Kasei Bioprocess America Form Strategic Partnership to Revolutionize Peptide Manufacturing
PeptiSystems and Asahi Kasei Bioprocess America have established an exclusive global partnership combining PeptiSystems' flow-through platform with AKBA's THESYS® ACS Ergo synthesis column technology.
EMA Recommends Approval of Averoa's XOANACYL for Chronic Kidney Disease Treatment
The European Medicines Agency's CHMP has issued a positive opinion for XOANACYL, an oral therapy for chronic kidney disease, with final European Commission approval expected by June 2025.
Akebia Therapeutics Secures $50 Million Through Public Offering to Advance Kidney Disease Treatments
Akebia Therapeutics has priced its public offering of 25 million shares at $2.00 per share, expecting to raise $50 million in gross proceeds to support its kidney disease-focused pipeline.
Akebia Therapeutics Expands Vafseo Access and Plans Phase 3 Trial for Non-Dialysis CKD Patients
Akebia Therapeutics has secured commercial supply contracts for Vafseo, covering nearly 100% of U.S. dialysis patients, with shipments commencing in January 2025.
GLP-1 Receptor Agonists and SGLT2 Inhibitors Show Promise in Cardio-Renal Protection
Vadadustat (Vafseo) was approved by the FDA for treating anemia caused by chronic kidney disease (CKD) in adults on dialysis for at least 3 months.
U.S. Renal Care Enrolls First Patients in VOICE Trial Evaluating Vafseo for CKD-Related Anemia
U.S. Renal Care has enrolled the first patients in the VOICE trial, assessing Vafseo (vadadustat) for anemia in chronic kidney disease (CKD) patients on dialysis.
Akebia Prepares Vafseo Launch for Dialysis Patients, Seeks Expansion to Pre-Dialysis Market
Akebia Therapeutics is set to launch Vafseo (vadadustat) in January 2025 for anemia treatment in dialysis patients, following its FDA approval in March.
Akebia Resubmits FDA Application for Vadadustat in Dialysis-Dependent CKD Anemia
Akebia Therapeutics has resubmitted its New Drug Application (NDA) to the FDA for vadadustat for anemia due to chronic kidney disease in adults on dialysis.