DescriptionCurator's Comment: description was created based on several sources, including
http://www.ncbi.nlm.nih.gov/pubmed/22971699; http://www.ncbi.nlm.nih.gov/pubmed/23318685
Curator's Comment: description was created based on several sources, including
http://www.ncbi.nlm.nih.gov/pubmed/22971699; http://www.ncbi.nlm.nih.gov/pubmed/23318685
Peginesatide (trade name Omontys, formerly Hematide), developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin. It was approved by the U.S. Food and Drug Administration for treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Peginesatide is a synthetic peptide, attached to polyethylene glycol ("PEGylated"). It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro.
Originator
Sources: https://www.sec.gov/Archives/edgar/data/1158223/000110465911068407/a11-31307_1ex99d1.htm
Curator's Comment: # Affymax and Takeda Pharmaceutical Company
Approval Year
Targets
| Primary Target | Pharmacology | Condition | Potency |
|---|---|---|---|
Target ID: P19235 Gene ID: 2057.0 Gene Symbol: EPOR Target Organism: Homo sapiens (Human) |
Conditions
| Condition | Modality | Targets | Highest Phase | Product |
|---|---|---|---|---|
| Primary | OMONTYS Approved UseIndicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Launch Date2012 |
PubMed
| Title | Date | PubMed |
|---|---|---|
| Relative safety of peginesatide and epoetin alfa. | 2014-10 |
|
| [New treatments of anemia in chronic renal failure]. | 2014-07-07 |
|
| Peginesatide as a new approach for treating anemia of CKD patient: is it like a falling star? | 2013-07 |
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| Peginesatide for anemia in chronic kidney disease. | 2013-04-18 |
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| Peginesatide for anemia in chronic kidney disease. | 2013-04-18 |
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| Lessons learned from peginesatide in the treatment of anemia associated with chronic kidney disease in patients on dialysis. | 2013 |
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| Managing dialysis patients who develop anemia caused by chronic kidney disease: focus on peginesatide. | 2013 |
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| Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis. | 2012-09-04 |
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| Detection of peginesatide in equine serum using liquid chromatography-tandem mass spectrometry for doping control purposes. | 2012 |
|
| Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profile. | 2009-11 |
Patents
Sample Use Guides
Initiate OMONTYS treatment when the hemoglobin level is less than 10 g/dL. The recommended starting dose for the treatment of anemia in patients who are not currently
treated with an ESA is 0.04 mg/kg body weight administered as a single intravenous or subcutaneous injection once monthly.
Route of Administration:
Intravenous
| Substance Class |
Protein
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| Sequence Type | COMPLETE |
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| From | To |
|---|---|
| 1_6 | 1_15 |
| 2_6 | 2_15 |
| Linkage Type | Residue Index | |
|---|---|---|
| AMIDE BOND | 1_21 | 2_21 |
| Related Record | Type | Details | ||
|---|---|---|---|---|
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STARTING MATERIAL -> INGREDIENT | |||
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PARENT -> SALT/SOLVATE |
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ACTIVE MOIETY |
Agent Modifications
| Modification Process | Modification Role | Modification Type | Amount | Fragment Name | Fragment ID |
|---|---|---|---|---|---|
| ACETYLATION | ACETYLATION | CHEMICAL |
|
Acetic acid | Q40Q9N063P |
Structural Modifications
| Modification Type | Location Site | Location Type | Residue Modified | Extent | Fragment Name | Fragment Approval |
|---|---|---|---|---|---|---|
| AMINO ACID SUBSTITUTION | [1_21] [2_21] | PEGINESATIDE LINKER | 6AL831EWE1 | |||
| AMINO ACID SUBSTITUTION | [1_1] [2_1] | ACETURIC ACID | U2UT4677KR | |||
| AMINO ACID SUBSTITUTION | [1_13] [2_13] | 1-NAPHTHYL-L-ALANINE | 9G930UL92R | |||
| AMINO ACID SUBSTITUTION | [1_20] [2_20] | SARCOSINE | Z711V88R5F |
| Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
|---|---|---|---|---|---|---|
| MOL_WEIGHT:SEQUENCE(CALCULATED) | CHEMICAL |
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| Molecular Formula | CHEMICAL |
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