| Revision as of 22:46, 13 November 2011 editCheMoBot (talk | contribs)Bots141,565 edits Updating {{drugbox}} (changes to verified fields - updated 'ChemSpiderID_Ref', 'UNII_Ref', 'ChEMBL_Ref', 'ChEBI_Ref', 'KEGG_Ref', 'StdInChI_Ref', 'StdInChIKey_Ref', 'CAS_number_Ref') per Chem/Drugbox validation (report [[Misplaced Pages...← Previous edit | Latest revision as of 19:46, 26 November 2022 edit undoCitation bot (talk | contribs)Bots5,429,012 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 | | Verifiedfields = changed | ||
| | Watchedfields = changed | |||
| | verifiedrevid = |
| 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 --> | ||
| Line 17: | Line 17: | ||
| | 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_Ref = {{cascite| |
||
| | CAS_number = 909402-77-3 | | CAS_number = 909402-77-3 | ||
| | UNII_Ref = {{fdacite|correct|FDA}} | |||
| | 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 = |
| ChemSpiderID = none | ||
| | KEGG = D09663 | |||
| <!--Chemical data--> | <!-- Chemical data --> | ||
| | chemical_formula = | | chemical_formula = | ||
| ⚫ | | molecular_weight = Antibodies 144.8–148.8 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> | |||
| ⚫ | | molecular_weight = Antibodies |
||
| ⚫ | }} | ||
| ==Clinical trials== | |||
| '''Rozrolimupab''' (Sym001) is a ] used in the treatment of ], prevention of ] in Rh-negative ] women.<ref>, ''American Medical Association''.</ref> | |||
| 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== | |||
| This drug was developed by ] A/S. | |||
| 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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{{blood-drug-stub}} | ||
Latest revision as of 19:46, 26 November 2022
Chemical compound Pharmaceutical compound| Clinical data | |
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| Molar mass | Antibodies 144.8–148.8 kg/mol |
| (what is this?) (verify) | |
Rozrolimupab is a recombinant antibody mixture, specifically containing 25 Rhesus D, or RhD, human antibodies, and is currently under development by Symphogen for the treatment of immune thrombocytopenic purpura (ITP) and for the prevention of hemolytic disease of the newborn (HDN).
Clinical trials
Phase two trials have proved to be promising. Utilizing a single intravenous infusion dosing, this phase was held in 41 centers across the United States, Europe, and Asia in order to evaluate an effective dose. 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, pyrexia, 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.
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.
References
- ^ "Symphogen Rozrolimupab". Archived from the original on 2013-05-13. Retrieved 2013-12-11.
- Easdale S, Stasi R (July 2013). "Rozrolimupab, a first-in-class recombinant monoclonal antibody product for primary immune thrombocytopaenia". Expert Opinion on Biological Therapy. 13 (7): 1085–92. doi:10.1517/14712598.2013.800856. PMID 23688321. S2CID 27029201.
- "Symphogen Pressroom". Archived from the original on 2013-12-11. Retrieved 2013-12-11.
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