peginesatide

{{Short description|Pharmaceutical drug}}

{{Drugbox

| IUPAC_name = Poly(oxy-1,2-ethanediyl), α-hydro-ω-methoxy-, diester with 21N⁶,21'N⁶-{[(N²,N⁶-dicarboxy-L-lysyl-β-alanyl)imino]bis(1-oxo-2,1-ethanediyl)}bis[N-acetylglycylglycyl-L-leucyl-L-tyrosyl-L-alanyl-L-cysteinyl-L-histidyl-L-methionylglycyl-L-prolyl-L-isoleucyl-L-threonyl-3-(1-naphthalenyl)-L-alanyl-L-valyl-L-cysteinyl-L-glutaminyl-L-prolyl-L-leucyl-L-arginyl-N-methylglycyl-L-lysinamide] cyclic (6→15),(6'→15')-bis(disulfide)

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| tradename = Omontys

| Drugs.com = {{drugs.com|parent|Omontys}}

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| licence_EU =

| licence_US = OMONTYS

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| pregnancy_AU =

| pregnancy_US = C

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| legal_US = Rx-only

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| routes_of_administration = Subcutaneous, intravenous

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| CAS_number = 913976-27-9

| CAS_supplemental =
{{CAS|1185870-58-9}} (acetate)

| UNII_Ref = {{fdacite|correct|FDA}}

| UNII = JX56W9N61Q

| ATCvet =

| ATC_prefix = B03

| ATC_suffix = XA04

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| PubChemSubstance = 124490628

| IUPHAR_ligand = 7447

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| ChemSpiderID = none

| KEGG = D09946

| ChEBI_Ref = {{ebicite|correct|EBI}}

| ChEBI = 66889

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| chemical_formula = C₂₃₁H₃₅₀N₆₂O₅₈S₆[C₂H₄O]_n

| molecular_weight = 45

| molecular_weight_comment = kg/mol

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Peginesatide (INN/USAN, 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. On February 23, 2013, Affymax and Takeda issued a press release indicating that they were recalling all batches of peginesatide from the market.FDA alerts health care providers of recall of anemia drug Omontys. U.S. Food and Drug Administration

[https://web.archive.org/web/20130227025228/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340899.htm] On June 16, 2014, Affymax and Takeda issued a press release stating that Takeda will work with the FDA to withdraw the peginesatide New Drug Application.Affymax and Takeda Announce Termination of Omontys® (peginesatide)

Product Collaboration and License Agreement. Takeda will withdraw the Omontys U.S. New Drug Application (NDA)[https://www.takeda.com/news/2014/20140616_6605.html]

Two randomized controlled trials published in 2013 found that the effectiveness of peginesatide was not inferior to epoetin for patients receiving dialysis (the EMERALD study),{{cite journal |vauthors=Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A | title = Peginesatide in patients with anemia undergoing hemodialysis | journal = N. Engl. J. Med. | volume = 368 | issue = 4 | pages = 307–19 |date=January 2013 | pmid = 23343061 | doi = 10.1056/NEJMoa1203165 | hdl = 10486/664909 | hdl-access = free }} or to darbepoetin for patients with chronic kidney disease who were not receiving dialysis (the PEARL study).{{cite journal |vauthors=Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S | title = Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis | journal = N. Engl. J. Med. | volume = 368 | issue = 4 | pages = 320–32 |date=January 2013 | pmid = 23343062 | doi = 10.1056/NEJMoa1203166 | doi-access = free }} However, the safety endpoint of cardiovascular events and death was worse for peginesatide than for darbepoetin in the PEARL study.