Sucroferric oxyhydroxide
Established medicineAlso known as Velphoro, iron (as sucroferric oxyhydroxide).
Recent clinical, regulatory, research and industry developments relating to this drug.
Indication expansion: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Label change: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Indication expansion: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Label change: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Label change: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Label change: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Supplemental approval: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Label change: SUCROFERRIC OXYHYDROXIDE (NDA205109)
Marketing authorisation: Velphoro (EMA)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro is… Show full indicationShow less
Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on dialysis. Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Recent completions
Trials that read out recently, adding to the completed evidence base.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.