AURYXIA (ferric citrate)
Auryxia is a medication used to manage specific complications in adults with chronic kidney disease. For patients undergoing dialysis, it helps control high phosphorus levels in the blood. In patients who are not on dialysis, it treats iron deficiency anemia by serving as an iron replacement. This medication addresses different needs depending on the stage of a patient's kidney disease and their specific blood chemistry requirements.
How AURYXIA Works
This drug works by binding to dietary phosphate within the gastrointestinal tract, forming an insoluble compound that is excreted in the stool to lower blood phosphorus levels. To address anemia, the ferric iron is reduced and transported into the bloodstream, where it binds to the protein transferrin. Once in circulation, the iron can be incorporated into hemoglobin to help resolve iron deficiency.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-09-05
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET
AURYXIA Approval History
What AURYXIA Treats
3 indicationsAURYXIA is approved for 3 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperphosphatemia
- Chronic Kidney Disease
- Iron Deficiency Anemia
AURYXIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AURYXIA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04741646 FIT4KID | U01DK122013 1U01DK122013, 22-001133 | Ph 2 | recruiting | Ferric Citrate and Chronic Kidney Disease in Children |
| NCT04523727 | KRX-0502-308 | Ph 3 | suspended | Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease |
| NCT04649411 | KRX-0502-309 | Ph 3 | withdrawn | Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease |
| NCT04543812 | PBB00601 | Ph 3 | completed | PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD |
| NCT02661295 results posted | WUH 756275-1 | Ph 4 | terminated | A Study of Ferric Citrate to Improve Inflammation and Lipid Levels |
| NCT03079869 results posted | FeCitrate 11035 | Ph 4 | completed | Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients |
| NCT03984760 | WG-PBB00302 | Ph 3 | completed | Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis |
| NCT01503736 | PNC00301 | Ph 3 | completed | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease |
| NCT03256838 | PBB00501 | Ph 4 | completed | Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis |
| NCT03055598 | H-39364 Ferric Citrate in ESRD | Ph 4 | active not recruiting | Ferric Citrate in ESRD Pilot Project |
| NCT02492620 05D | 05D | Ph 3 | completed | Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D |
| NCT02268994 results posted | KRX-0502-306 | Ph 3 | completed | KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD |
| NCT01736397 results posted | KRX-0502-204 | Ph 2 | completed | Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis |
| NCT00648167 results posted | KRX-0502-201 | Ph 2 | completed | A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) |
| NCT01554982 results posted | KRX-0502-307 | Ph 3 | completed | A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis |
| NCT01074125 results posted | KRX-0502-305 | Ph 3 | completed | A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AURYXIA FDA Label Details
Indications & Usage
FDA Label (PDF)AURYXIA is indicated for the treatment of Hyperphosphatemia; Chronic Kidney Disease; Iron Deficiency Anemia.
Pro Intelligence Preview
Deep insights for AURYXIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 3 active patents
Trial Analysis
- • 19 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment