U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Description
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.

CNS Activity

CNS Non-penetrant
1040
Curator's Comment: In rats there was no evidence that peginesatide distributes beyond the blood-brain barrier

Originator

Approval Year

2012
608
Targets

Targets

Primary TargetPharmacologyConditionPotency
Erythropoietin receptor
2
Target ID: P19235
Gene ID: 2057.0
Gene Symbol: EPOR
Target Organism: Homo sapiens (Human)
Activator
1447
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8583
OMONTYS

Approved Use

Indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Launch Date

2012
PubMed

PubMed

TitleDatePubMed
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
Peginesatide for anemia in chronic kidney disease.
2013-04-18
Peginesatide for anemia in chronic kidney disease.
2013-04-18
Lessons learned from peginesatide in the treatment of anemia associated with chronic kidney disease in patients on dialysis.
2013
Managing dialysis patients who develop anemia caused by chronic kidney disease: focus on peginesatide.
2013
Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis.
2012-09-04
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

Patents

US2014335186
2

Sample Use Guides

In Vivo Use Guide
Curator's Comment: intravenous or subcutaneous injection
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
In Vitro Use Guide
Unknown
Substance Class Protein
Created
by admin
on Tue Apr 01 20:41:06 GMT 2025
Edited
by admin
on Tue Apr 01 20:41:06 GMT 2025
Protein Sub Type
Sequence Type COMPLETE
Record UNII
JX56W9N61Q
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
PEGINESATIDE
DASH   INN   MART.   USAN   VANDF   WHO-DD  
USAN   INN  
Official Name English
peginesatide [INN]
Preferred Name English
PEGINESATIDE [MI]
Common Name English
PEGINESATIDE [USAN]
Common Name English
AF37702
Code English
AF-37702
Code English
Peginesatide [WHO-DD]
Common Name English
HEMATIDE
Brand Name English
PEGINESATIDE [VANDF]
Common Name English
PEGINESATIDE ACETATE [JAN]
Common Name English
PEGINESATIDE [MART.]
Common Name English
Classification Tree Code System Code
WHO-VATC QB03XA04
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
LIVERTOX 746
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
WHO-ATC B03XA04
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
NDF-RT N0000175665
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
NCI_THESAURUS C2139
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
Code System Code Type Description
EVMPD
SUB33424
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
CHEBI
66889
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
LACTMED
Peginesatide
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
INN
9304
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
RXCUI
1248798
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY RxNorm
EPA CompTox
DTXSID501027898
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
NCI_THESAURUS
C48422
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
DRUG CENTRAL
4234
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
FDA UNII
JX56W9N61Q
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
WIKIPEDIA
Peginesatide
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
ChEMBL
CHEMBL2107866
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
CAS
1350810-60-4
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
ALTERNATIVE
IUPHAR
7447
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
USAN
ZZ-98
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
CAS
913976-27-9
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
DRUG BANK
DB08894
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
SMS_ID
100000126105
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
MERCK INDEX
m11692
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
MESH
C556270
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
MESH
C514771
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
HSDB
8181
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
CHEBI
66895
Created by admin on Tue Apr 01 20:41:06 GMT 2025 , Edited by admin on Tue Apr 01 20:41:06 GMT 2025
PRIMARY
From To
1_6 1_15
2_6 2_15
Related Record Type Details
PEGINESATIDE ACETATE
INGREDIENT -> STARTING MATERIAL
PEGINESATIDE ACETATE
SALT/SOLVATE -> PARENT
Related Record Type Details
PEGINESATIDE
ACTIVE MOIETY

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
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_21] [2_21] PEGINESATIDE LINKER 6AL831EWE1
AMINO ACID SUBSTITUTION [1_20] [2_20] SARCOSINE Z711V88R5F
Name Property Type Amount Referenced Substance Defining Parameters References
MOL_WEIGHT:SEQUENCE(CALCULATED) CHEMICAL
Molecular Formula CHEMICAL
NIH
NCATS
PRIVACY NOTICE
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
For language access assistance, contact the NCATS Public Information Officer
National Center for Advancing Translational Sciences (NCATS),
6701 Democracy Boulevard, Bethesda MD 20892-4874 • 301-594-8966