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Revision as of 09:11, 10 January 2011 edit85.24.240.67 (talk) removed vandalism← Previous edit Latest revision as of 19:46, 26 November 2022 edit undoCitation bot (talk | contribs)Bots5,429,026 edits Add: s2cid. | Use this bot. Report bugs. | Suggested by BorgQueen | Category:Chemicals that do not have a ChemSpider ID assigned | #UCB_Category 47/851 
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{{Short description|Chemical compound}}
{{Orphan|date=December 2009}}
{{Drugbox {{Drugbox
| Verifiedfields = changed
| IUPAC_name = 1. Anti-RhD recombinant human polyclonal antibody composed of 25 unique IgG1 antibodies<br>2. Recombinant human antigen-specific polyclonal antibody (pAb) against RhD antigen expressed in Chinese hamster ovary cells
| Watchedfields = changed
| image =
| verifiedrevid = 464384094
| CAS_number = 909402-77-3
| IUPAC_name =
| ATC_prefix = none
| ATC_suffix = | image =
<!-- Clinical data -->
| PubChem =
| DrugBank = | tradename =
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| chemical_formula =
| pregnancy_US = <!-- A / B / C / D / X -->
| molecular_weight = Antibodies in the 144.8 -148.8 kDa range
| pregnancy_category =
| bioavailability =
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| protein_bound =
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| metabolism =
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| elimination_half-life =
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| excretion =
| legal_status =
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| routes_of_administration =
| pregnancy_US = <!-- A / B / C / D / X -->
<!-- Pharmacokinetic data -->
| pregnancy_category=
| bioavailability =
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| protein_bound =
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| metabolism =
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| elimination_half-life =
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_status = | excretion =
<!-- Identifiers -->
| routes_of_administration =
| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 909402-77-3
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = S134V96RPQ
| ATC_prefix = none
| ATC_suffix =
| PubChem =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank =
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| KEGG = D09663
<!-- Chemical data -->
| chemical_formula =
| molecular_weight = Antibodies 144.8&ndash;148.8 kg/mol
}} }}


'''Rozrolimupab''' is a ] mixture, specifically containing 25 Rhesus D, or ], human antibodies, and is currently under development by ] for the treatment of ] (ITP) and for the prevention of ] (HDN).<ref name="Rozrolimupab(Sym001)">{{cite web | title = Symphogen Rozrolimupab | url = http://www.symphogen.com/web/guest/sym001 | accessdate = 2013-12-11 | url-status = dead | archiveurl = https://web.archive.org/web/20130513215133/http://www.symphogen.com/web/guest/sym001 | archivedate = 2013-05-13 }}</ref><ref name="Easdale_2013">{{cite journal | vauthors = Easdale S, Stasi R | title = Rozrolimupab, a first-in-class recombinant monoclonal antibody product for primary immune thrombocytopaenia | journal = Expert Opinion on Biological Therapy | volume = 13 | issue = 7 | pages = 1085–92 | date = July 2013 | pmid = 23688321 | doi = 10.1517/14712598.2013.800856 | s2cid = 27029201 }}</ref>
'''Rozrolimupab''' (Sym001) is a ] used in the treatment of ], prevention of ] in Rh-negative ] women.<ref>, ''American Medical Association''.</ref>


==Clinical trials==
This drug was developed by ] A/S.
Phase two trials have proved to be promising. Utilizing a single ] infusion dosing, this phase was held in 41 centers across the United States, Europe, and Asia in order to evaluate an effective dose.<ref name="Rozrolimupab(Sym001)">{{cite web | title = Symphogen Rozrolimupab | url = http://www.symphogen.com/web/guest/sym001 | accessdate = 2013-12-11 | url-status = dead | archiveurl = https://web.archive.org/web/20130513215133/http://www.symphogen.com/web/guest/sym001 | archivedate = 2013-05-13 }}</ref> The 61 patient study was assessing rozrolimupab's ability to effectively treat ITP and HDN as well as how safe and tolerable the drug is. Common adverse effects included mild to moderate headache, ], chills, and fatique. The study showed that administration of the drug did effect platelet responses in the blood, with a median time of response of roughly two and a half days, and on average lasting a total of 14 days.<ref name="RozrolimupabPressroom">{{cite web | title = Symphogen Pressroom | url = http://www.symphogen.com/web/guest/newsarchive/readmore?p_p_id=56_INSTANCE_ZUuU&articleId=161776 | archive-url = https://archive.today/20131211195702/http://www.symphogen.com/web/guest/newsarchive/readmore?p_p_id=56_INSTANCE_ZUuU&articleId=161776 | url-status = dead | archive-date = 2013-12-11 | accessdate = 2013-12-11 }}</ref>

==Current ITP and HDN treatment==
While the current blood-derived treatment has proved successful, its dependence on a donor population proves problematic. Rozrolimupab's manufactured antibody mixture may be an alternative.<ref name="Rozrolimupab(Sym001)">{{cite web | title = Symphogen Rozrolimupab | url = http://www.symphogen.com/web/guest/sym001 | accessdate = 2013-12-11 | url-status = dead | archiveurl = https://web.archive.org/web/20130513215133/http://www.symphogen.com/web/guest/sym001 | archivedate = 2013-05-13 }}</ref>


==References== ==References==
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