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{{Short description|Monoclonal antibody}} | |||
{{Drugbox | {{Drugbox | ||
| Verifiedfields = changed | | Verifiedfields = changed | ||
| verifiedrevid = |
| verifiedrevid = 458270653 | ||
| type = mab | | type = mab | ||
| image = |
| image = | ||
| alt = |
| alt = | ||
| mab_type = mab | | mab_type = mab | ||
| source = zu | | source = zu | ||
| target = ] | | target = ] | ||
<!--Clinical data--> | <!--Clinical data --> | ||
| tradename = |
| tradename = Alzumab | ||
| Drugs.com = | | Drugs.com = | ||
| MedlinePlus = | | MedlinePlus = | ||
| 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 = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> | | legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> | ||
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM --> | | legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM --> | ||
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> | | legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> | ||
| legal_status = | | legal_status = Approved in India | ||
| routes_of_administration = |
| routes_of_administration = | ||
⚫ | <!-- Pharmacokinetic data --> | ||
| bioavailability = | |||
⚫ | <!--Pharmacokinetic data--> | ||
| |
| protein_bound = | ||
| |
| metabolism = | ||
⚫ | | elimination_half-life = | ||
| |
| excretion = | ||
⚫ | | elimination_half-life = |
||
⚫ | <!-- Identifiers --> | ||
⚫ | | |
||
⚫ | <!--Identifiers--> | ||
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} | | ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} | ||
| ChemSpiderID = |
| ChemSpiderID = none | ||
| CAS_number_Ref = {{cascite| |
| CAS_number_Ref = {{cascite|changed|CAS}} | ||
| CAS_number = |
| CAS_number = 1116433-11-4 | ||
⚫ | | |
||
⚫ | | |
||
| UNII_Ref = {{fdacite|correct|FDA}} | | UNII_Ref = {{fdacite|correct|FDA}} | ||
| UNII = XQQ2RHV14N | | UNII = XQQ2RHV14N | ||
| |
| ATC_prefix = none | ||
⚫ | | ATC_suffix = | ||
⚫ | | PubChem = | ||
⚫ | | KEGG = D12426 | ||
| DrugBank_Ref = {{drugbankcite|correct|drugbank}} | | DrugBank_Ref = {{drugbankcite|correct|drugbank}} | ||
| DrugBank = |
| DrugBank = | ||
⚫ | <!-- Chemical data --> | ||
| chemical_formula = | |||
⚫ | <!--Chemical data--> | ||
| |
| molecular_weight = | ||
| molecular_weight = | |||
}} | }} | ||
'''Itolizumab''' (], trade name '''Alzumab''') is a 'first in class' humanized IgG1 ] developed by ]<ref name=jayaraman2013>{{cite news | vauthors = Jayaramun K | title=Biocon's first-in-class anti-CD6 mAb reaches the market | date=December 2013 | pages=1062–3 | volume=31 | issue=12 | work=] | location=United Kingdom | url=http://www.nature.com/nbt/journal/v31/n12/full/nbt1213-1062b.html }}{{closed access}}</ref> and the ] (CIM), Havana.<ref>{{Cite web|url=https://theprint.in/health/india-prepares-to-test-itolizumab-the-drug-credited-for-lowering-covid-mortality-in-cuba/431666/|title=India prepares to test Itolizumab, the drug credited for lowering Covid mortality in Cuba|date=May 30, 2020}}</ref> | |||
'''Itolizumab''' is an immunomodulator. It binds to ].<ref>{{cite journal | author = ] | title = International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 103 | journal = WHO Drug Information | year = 2010 | url = http://www.who.int/medicines/publications/druginformation/INN_PL103.pdf | format=PDF}}</ref> | |||
== Mechanism of action == | |||
It selectively targets ], a pan ] marker involved in ], adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory ]s and possibly plays an important role by reducing T cell infiltration at sites of inflammation.<ref>{{cite web | title = Biocon Receives Marketing Authorization for its Novel Biologic Itolizumab for Psoriasis | url = http://www.biocon.com/docs/PR_080113.pdf?subLink=news | date = 8 January 2013 | publisher = Biocon Limited }}</ref> | |||
== Clinical trials == | |||
A double blind, placebo controlled, phase III treat –Plaq study of itolizumab successfully met the pre-specified primary end-point of significant improvement in PASI-75 (]) score after 12 weeks of treatment in patients with moderate to severe ] compared to placebo.<ref>{{Cite web|url=https://www.thehindubusinessline.com/companies/biocons-test-shows-positive-results-for-itolizumab/article23068151.ece|title=Biocon's test shows positive results for Itolizumab | vauthors = Urs A |website=@businessline|date=10 January 2012 }}</ref> | |||
== Applications == | |||
Biocon received marketing authorization for the drug from the ] (DCGI) in January 2013 and marketing within India commenced in August 2013.<ref name="jayaraman2013" /><ref>{{cite news | title=Biocon's psoriasis drug, Itolizumab receives DCGI marketing authorization | date=January 8, 2013 | work=Pharmabiz.com | publisher=Saffron Media | location=India | url=http://www.pharmabiz.com/NewsDetails.aspx?aid=73075&sid=2 | access-date=January 10, 2013 | archive-date=February 19, 2017 | archive-url=https://web.archive.org/web/20170219170401/http://www.pharmabiz.com/NewsDetails.aspx?aid=73075&sid=2 | url-status=dead }}</ref> | |||
In July 2020, Biocon received authorization in India for its use in the treatment of ].<ref>{{Cite web |title=Biocon's Itolizumab approved for COVID-19 treatment: All you need to know |url= https://economictimes.indiatimes.com/industry/healthcare/biotech/biocons-itolizumab-approved-for-covid-19-treatment-all-you-need-to-know/videoshow/76943684.cms |access-date=2020-07-14 |website=The Economic Times}}</ref> | |||
== References == | == References == | ||
<references/> | <references /> | ||
{{monoclonals for immune system}} | {{monoclonals for immune system}} | ||
] | |||
] | |||
] | |||
Latest revision as of 11:39, 20 September 2024
Monoclonal antibody Pharmaceutical compoundMonoclonal antibody | |
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Type | Whole antibody |
Source | Humanized |
Target | CD6 |
Clinical data | |
Trade names | Alzumab |
ATC code |
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Legal status | |
Legal status |
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Identifiers | |
CAS Number | |
ChemSpider |
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UNII | |
KEGG | |
(what is this?) (verify) |
Itolizumab (INN, trade name Alzumab) is a 'first in class' humanized IgG1 monoclonal antibody developed by Biocon and the Center of Molecular Immunology (CIM), Havana.
Mechanism of action
It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation.
Clinical trials
A double blind, placebo controlled, phase III treat –Plaq study of itolizumab successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.
Applications
Biocon received marketing authorization for the drug from the Drugs Controller General of India (DCGI) in January 2013 and marketing within India commenced in August 2013.
In July 2020, Biocon received authorization in India for its use in the treatment of COVID-19.
References
- ^ Jayaramun K (December 2013). "Biocon's first-in-class anti-CD6 mAb reaches the market". Nat. Biotechnol. Vol. 31, no. 12. United Kingdom. pp. 1062–3.[REDACTED]
- "India prepares to test Itolizumab, the drug credited for lowering Covid mortality in Cuba". May 30, 2020.
- "Biocon Receives Marketing Authorization for its Novel Biologic Itolizumab for Psoriasis" (PDF). Biocon Limited. 8 January 2013.
- Urs A (10 January 2012). "Biocon's test shows positive results for Itolizumab". @businessline.
- "Biocon's psoriasis drug, Itolizumab receives DCGI marketing authorization". Pharmabiz.com. India: Saffron Media. January 8, 2013. Archived from the original on February 19, 2017. Retrieved January 10, 2013.
- "Biocon's Itolizumab approved for COVID-19 treatment: All you need to know". The Economic Times. Retrieved 2020-07-14.
This monoclonal antibody–related article is a stub. You can help Misplaced Pages by expanding it. |
This antineoplastic or immunomodulatory drug article is a stub. You can help Misplaced Pages by expanding it. |