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Revision as of 13:13, 6 December 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Saving copy of the {{drugbox}} taken from revid 460512832 of page Rozrolimupab for the Chem/Drugbox validation project (updated: 'CAS_number').  Latest revision as of 19:46, 26 November 2022 edit Citation bot (talk | contribs)Bots5,414,748 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}}
{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}}
{{Drugbox {{Drugbox
| Verifiedfields = changed | Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 407040478 | verifiedrevid = 464384094
| 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
| IUPAC_name =
| image = | image =
<!-- Clinical data -->

<!--Clinical data-->
| tradename = | tradename =
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X --> | pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category = | pregnancy_category =
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> | legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
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| legal_status = | legal_status =
| routes_of_administration = | routes_of_administration =
<!-- Pharmacokinetic data -->

<!--Pharmacokinetic data-->
| bioavailability = | bioavailability =
| protein_bound = | protein_bound =
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| elimination_half-life = | elimination_half-life =
| excretion = | excretion =
<!-- Identifiers -->

| CAS_number_Ref = {{cascite|changed|??}}
<!--Identifiers-->
| CAS_number = 909402-77-3
| CAS_number_Ref = {{cascite|correct|??}}
| UNII_Ref = {{fdacite|correct|FDA}}
| CAS_number = <!-- blanked - oldvalue: 909402-77-3 -->
| UNII = S134V96RPQ
| ATC_prefix = none | ATC_prefix = none
| ATC_suffix = | ATC_suffix =
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| DrugBank = | DrugBank =
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} | ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = NA | ChemSpiderID = none
| KEGG = D09663

<!--Chemical data--> <!-- Chemical data -->
| chemical_formula = | chemical_formula =
| molecular_weight = Antibodies 144.8&ndash;148.8 kg/mol

| molecular_weight = Antibodies in the 144.8 -148.8 kDa range
}} }}

'''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>

==Clinical trials==
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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