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Akebia Therapeutics (AKBA)
NASDAQ:AKBA
Vadadustat
Anemia Of Chronic Kidney Disease
Phase III
Suspended
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
Sep 28, 2021
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Vadadustat
Anemia Of Chronic Kidney Disease
Phase III
Suspended
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
Sep 28, 2021
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Vadadustat, Mircera®
Anemia Associated With Chronic Kidney Disease (Ckd)
Phase III
Completed
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
Jan 12, 2021
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Vadadustat
Chronic Kidney Disease
Phase II
Completed
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
Nov 02, 2020
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Vadadustat, Darbepoetin Alfa
Anemia
Phase III
Completed
Trial 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
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Vadadustat, Sevelamer Carbonate, Calcium Acetate, Auryxia®
Healthy Volunteers
Phase I
Completed
Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
Mar 05, 2020
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Epoetin Alfa, Vadadustat, Darbepoetin Alfa
Anemia Associated With Chronic Kidney Disease
Phase I
Completed
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease
Jun 18, 2019
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Rosuvastatin, Atorvastatin, Simvastatin, Sulfasalazine, Pravastatin, Vadadustat
Drug Interaction Potentiation
Phase I
Completed
Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin
Dec 27, 2018
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Digoxin, Vadadustat, Furosemide, Adefovir
Drug Interaction Potentiation
Phase I
Completed
Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide
Dec 27, 2018
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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
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
AKBA is currently developing the following drugs: Vadadustat, Erythropoiesis-Stimulating Agent (Esa), Vadadustat, Vadadustat. These drug candidates are in various stages of clinical development as the company works toward FDA approval.