EXTRANEAL
LOE Approachingicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
NDAINTRAPERITONEALSOLUTION
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
5/8 — Partial
EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) by Vantive is (icodextrin) as the primary osmotic agent. Approved for (compared to 4. First approved in 2002.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXTRANEAL is an intraperitoneal dialysis solution containing icodextrin as the primary osmotic agent, designed for patients requiring peritoneal dialysis. Icodextrin functions as a colloid osmotic agent to achieve ultrafiltration during long peritoneal dialysis dwells by exerting osmotic pressure across small intercellular pores. The solution also contains electrolytes and lactate to normalize electrolyte balance and acid-base status.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team contraction or transition planning in coming years.
Mechanism of Action
(icodextrin) as the primary osmotic agent. Icodextrin functions as a colloid osmotic agent to achieve ultrafiltration during long peritoneal dialysis dwells. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary…
Indications (1)
Clinical Trials (4)
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
Started Jun 2024
439 enrolled
Chronic Renal Failure
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
Started Jun 2014
22 enrolled
End Stage Renal Disease
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Started Oct 2010
71 enrolled
End Stage Renal Disease (ESRD)DiabetesCAPD
Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients
Started Nov 2006
0Peritoneal DialysisHypertriglyceridemia
Worked on EXTRANEAL at Vantive? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.