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Akebia Therapeutics (AKBA) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
PraliciguatFocal Segmental GlomerulosclerosisPhase IIRecruitingA Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)Nov 26, 2025―
Vadadustat, Erythropoiesis-Stimulating AgentAnemia Of Chronic Kidney DiseasePhase IIIRecruitingTo Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center HemodialysisMar 27, 2025
VadadustatAnemia Of Chronic Kidney DiseasePhase IIIWithdrawnStudy to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney DiseaseSep 28, 2021
VadadustatAnemia Of Chronic Kidney DiseasePhase IIIWithdrawnStudy to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating AgentsSep 28, 2021
Vadadustat, MirceraAnemia Associated With Chronic Kidney Disease (Ckd)Phase IIICompletedStudy 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 SubjectsJan 12, 2021―
VadadustatChronic Kidney DiseasePhase IICompletedStudy to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4Nov 02, 2020―
Vadadustat, Darbepoetin AlfaAnemiaPhase IIICompletedTrial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)Mar 16, 2020―
Vadadustat, Sevelamer Carbonate, Calcium Acetate, AuryxiaHealthy VolunteersPhase ICompletedStudy in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of VadadustatMar 05, 2020―
Epoetin Alfa, Vadadustat, Darbepoetin AlfaAnemia Associated With Chronic Kidney DiseasePhase ICompletedStudy to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney DiseaseJun 18, 2019―
Rosuvastatin, Atorvastatin, Simvastatin, Sulfasalazine, Pravastatin, VadadustatDrug Interaction PotentiationPhase ICompletedDrug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and SimvastatinDec 27, 2018―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Akebia Therapeutics (AKBA) have in its pipeline
Akebia Therapeutics AKBA is currently developing the following drugs: Praliciguat, Vadadustat, Erythropoiesis-Stimulating Agent, Vadadustat, Vadadustat, Mircera, Vadadustat, Darbepoetin Alfa, Vadadustat, Sevelamer Carbonate, Calcium Acetate, Auryxia, Epoetin Alfa, Vadadustat, Darbepoetin Alfa, Rosuvastatin, Atorvastatin, Simvastatin, Sulfasalazine, Pravastatin, Vadadustat, Digoxin, Vadadustat, Furosemide, Adefovir, Vadadustat, Rabeprazole, Rifampin, Probenecid, Vadadustat, Cyclosporins, Epoetin Alfa, Vadadustat, Vadadustat Tiw, Vadadustat Reference Tablets, Vadadustat Test Tablets, Iw-1973, Epoetin Alfa, Vadadustat, Celecoxib, Akb-6548, Akb-6548 Tablet, Reference Formulation Given In The Fasted State, Akb-6548 Tablet, Test Formulation Given In The Fasted State., Akb-6548 Tablet, Test Formulation Given In The Fed State, Akb-6548, Ferrous Sulfate, Akb-6548, Moxifloxacin, Akb-6548. These drug candidates are in various stages of clinical development as the company works toward FDA approval.