RENVELA (sevelamer carbonate)
Renvela (sevelamer carbonate) is a phosphate binder indicated for the control of serum phosphorus in adults and pediatric patients 6 years of age and older with chronic kidney disease (CKD) on dialysis.
How RENVELA Works
Renvela contains sevelamer carbonate, a non-absorbed, metal- and calcium-free, cross-linked polymer. It contains multiple amines that become protonated in the intestine, where they bind to dietary phosphate molecules through ionic and hydrogen bonding. By sequestering phosphate within the gastrointestinal tract and decreasing its absorption, sevelamer carbonate effectively lowers serum phosphorus concentrations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-10-19
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, TABLET
RENVELA Approval History
What RENVELA Treats
1 indicationsRENVELA is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Kidney Disease
RENVELA 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 RENVELA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01220843 FRENCH | PI10-PR-CHOUKROUN-1 2010-020872-49 | Ph 3 | completed | FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease |
| NCT06664125 | JMKX3002-H201 | Ph 2 | recruiting | Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia |
| NCT05764590 | AP306-HP-01 | Ph 2 | completed | A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients |
| NCT03427125 results posted | TEN-02-301 | Ph 3 | completed | A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis |
| NCT03988920 NORMALIZE results posted | TEN-02-401 | Ph 4 | completed | A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP |
| NCT04551300 | APCKD001 | Ph 2 | completed | A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients |
| NCT03644264 | PA-CL-CHINA-01 | Ph 3 | completed | PA21 Safety and Efficacy in Adult Chinese Subjects |
| NCT03984760 | WG-PBB00302 | Ph 3 | completed | Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis |
| NCT04299633 | AKB-6548-CI-0037 | Ph 1 | completed | Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat |
| NCT01543958 results posted | ACTG A5296 1U01AI068636 | Ph 2 | completed | Sevelamer for Reducing Endotoxemia and Immune Activation |
| NCT02965053 | EOS103US | Ph 1 | completed | A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis |
| NCT01191762 results posted | PhelpsK | Ph 3 | completed | Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease |
| NCT01574326 results posted | SVCARB07609 2011-002329-23, DRI12793 | Ph 2 | completed | An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease |
| NCT01427907 COS-002 results posted | COS-002 | Ph 4 | completed | Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients |
| NCT01277497 | 2902 | Ph 4 | terminated | Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4 |
| NCT00853242 LEAP results posted | APB00108 | Ph 2 | completed | Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis |
| NCT00833768 ASPIRE | SVCARB00606 Eudra CT: 2007-003885-16 | Ph 3 | terminated | A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis |
| NCT01736150 | SVCARB03808 | Ph 3 | completed | Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis |
| NCT02346890 | D5611C00006 | Ph 1 | completed | A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722 |
| NCT01324128 results posted | PA-CL-05A | Ph 3 | completed | A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients |
| NCT01493050 | GCO 11-0973 | Ph 2 | completed | The Effects of Sevelamer Carbonate on Diabetic Nephropathy |
| NCT01464190 results posted | PA-CL-05B | Ph 3 | completed | A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients |
| NCT01231438 | SUS2010GOLA01 2010-020415-36 | Ph 2 | completed | Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder. |
| NCT00806481 | RRK3563 SVCARB01508IST, 2008-003727-23 | Ph 2 | completed | Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease |
| NCT00967629 | GCO 08-0976 | Ph 1 | completed | Effect of Sevelamer Carbonate on Oxidative Stress in Patients With Diabetic Nephropathy |
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.
RENVELA FDA Label Details
Indications & Usage
FDA Label (PDF)RENVELA is indicated for the treatment of Chronic Kidney Disease.
RENVELA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for RENVELA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 4 active patents
Trial Analysis
- • 25 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