Drug Type Small molecule drug |
Synonyms Phosphate binder, Seboren, SBR 759 + [1] |
Target |
Action modulators |
Mechanism Phosphates modulators(Phosphates modulators) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
License Organization- |
Drug Highest PhaseDiscontinuedPhase 3 |
First Approval Date- |
Regulation- |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic Kidney Diseases | Phase 3 | Belgium | 01 Feb 2010 | |
Chronic Kidney Diseases | Phase 3 | Italy | 01 Feb 2010 | |
Hyperphosphatemia | Phase 3 | Belgium | 01 Feb 2010 | |
Hyperphosphatemia | Phase 3 | Italy | 01 Feb 2010 |
Phase 3 | 203 | lhvalmdcyt(iunyutwzrp) = more frequent with SBR759 cmikwkyadn (mzfuqhnato ) View more | Positive | 16 Nov 2010 | |||
Sevelamer-HCl | |||||||
Phase 2 | 203 | tnyxobnaor(jhltnqigmg) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) iiajoumode (axmcdxizmr ) | Positive | 16 Nov 2010 | |||