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MCI-196
MCI-196 is a phosphate binder that reduces serum phosphate levels by binding phosphate in the gastrointestinal tract.
MCI-196 is a phosphate binder that reduces serum phosphate levels by binding phosphate in the gastrointestinal tract. Used for Hyperphosphatemia in patients with chronic kidney disease on dialysis, Hyperphosphatemia in patients with chronic kidney disease not on dialysis.
At a glance
| Generic name | MCI-196 |
|---|---|
| Also known as | Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®, Colestilan(INN), |
| Sponsor | Tanabe Pharma Corporation |
| Drug class | Phosphate binder |
| Target | Dietary and secreted phosphate (non-selective binding) |
| Modality | Small molecule |
| Therapeutic area | Nephrology / Chronic Kidney Disease |
| Phase | Phase 3 |
Mechanism of action
MCI-196 (sucroferric oxyhydroxide) is an iron-based phosphate binder that works in the gastrointestinal lumen to bind dietary and secreted phosphate, preventing its absorption and reducing serum phosphate concentrations. This mechanism is particularly useful in patients with chronic kidney disease who have hyperphosphatemia, as elevated phosphate levels are associated with cardiovascular complications and mineral bone disease.
Approved indications
- Hyperphosphatemia in patients with chronic kidney disease on dialysis
- Hyperphosphatemia in patients with chronic kidney disease not on dialysis
Common side effects
- Discolored (dark) stool
- Gastrointestinal disorders
- Nausea
- Constipation
Key clinical trials
- A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (PHASE3)
- Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia (PHASE3)
- A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia (PHASE3)
- A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia (PHASE3)
- Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects (PHASE1)
- Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis (PHASE3)
- A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia (PHASE3)
- Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes (PHASE2)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MCI-196 CI brief — competitive landscape report
- MCI-196 updates RSS · CI watch RSS
- Tanabe Pharma Corporation portfolio CI