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Renvela (SEVELAMER CARBONATE)
Renvela works by binding to dietary phosphate in the gut, preventing its absorption into the bloodstream.
Renvela (Sevelamer Carbonate) is a phosphate binder, a small molecule drug developed by Genzyme, currently owned by the same company. It is used to treat renal osteodystrophy with hyperphosphatemia and patients undergoing renal dialysis. Renvela works by binding to dietary phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream. The drug is commercially available as a generic product, with over 20 manufacturers offering their versions. Key safety considerations include gastrointestinal side effects and potential interactions with other medications.
At a glance
| Generic name | SEVELAMER CARBONATE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Phosphate Binder |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2007 |
Mechanism of action
Sevelamer carbonate tablets contains sevelamer carbonate, non-absorbed phosphate-binding cross-linked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).
Approved indications
- Renal Osteodystrophy with Hyperphosphatemia
- Renal dialysis
Common side effects
- Vomiting
- Nausea
- Diarrhea
- Dyspepsia
- Abdominal pain
- Flatulence
- Constipation
- Peritonitis
- Fecal impaction
- Hypersensitivity
- Pruritus
- Rash
Key clinical trials
- AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia (PHASE3)
- FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease (PHASE3)
- Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
- Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia (PHASE2)
- Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders (PHASE4)
- Calcium-Phosphorus Regulation Therapy on Heart Valve Disease (PHASE4)
- Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis (PHASE3)
- A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Renvela CI brief — competitive landscape report
- Renvela updates RSS · CI watch RSS
- Sanofi portfolio CI