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Nemolizumab - Wikipedia

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class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Monoclonal antibody</div> <p class="mw-empty-elt"> </p> <div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Pharmaceutical compound</div> <style data-mw-deduplicate="TemplateStyles:r1269284339">@media screen{html.skin-theme-clientpref-night .mw-parser-output .dark_mode_safe img{background-color:var(--background-color-inverted,#f8f9fa)}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .dark_mode_safe img{background-color:var(--background-color-inverted,#f8f9fa)}}</style> <style data-mw-deduplicate="TemplateStyles:r1257001546">.mw-parser-output .infobox-subbox{padding:0;border:none;margin:-3px;width:auto;min-width:100%;font-size:100%;clear:none;float:none;background-color:transparent}.mw-parser-output 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style="border-spacing:2px;"><caption class="infobox-title"><span title="International nonproprietary name (INN): Nemolizumab">Nemolizumab</span></caption><tbody><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;"><a href="/wiki/Monoclonal_antibody" title="Monoclonal antibody">Monoclonal antibody</a></th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/File:Engineered_monoclonal_antibodies.svg" title="File:Engineered monoclonal antibodies.svg">Type</a></th><td class="infobox-data">Whole antibody</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Monoclonal_antibody#Production" title="Monoclonal antibody">Source</a></th><td class="infobox-data"><a href="/wiki/Humanized" class="mw-redirect" title="Humanized">Humanized</a></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Antigen" title="Antigen">Target</a></th><td class="infobox-data"><a href="/wiki/Interleukin-31_receptor_A" class="mw-redirect" title="Interleukin-31 receptor A">Interleukin-31 receptor A</a></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;">Clinical data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Drug_nomenclature#Trade_names" title="Drug nomenclature">Trade names</a></th><td class="infobox-data">Nemluvio</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;">Other names</th><td class="infobox-data">CIM-331, CD14152, nemolizumab-ilto</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/American_Society_of_Health-System_Pharmacists" title="American Society of Health-System Pharmacists">AHFS</a>/<a href="/wiki/Drugs.com" title="Drugs.com">Drugs.com</a></th><td class="infobox-data"><span title="www.drugs.com"><a rel="nofollow" class="external text" href="https://www.drugs.com/monograph/nemolizumab-ilto.html">Monograph</a></span></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/MedlinePlus" title="MedlinePlus">MedlinePlus</a></th><td class="infobox-data"><span title="medlineplus.gov"><a rel="nofollow" class="external text" href="https://medlineplus.gov/druginfo/meds/a624059.html">a624059</a></span></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">License data</a></th><td class="infobox-data"><style data-mw-deduplicate="TemplateStyles:r1126788409">.mw-parser-output .plainlist ol,.mw-parser-output .plainlist ul{line-height:inherit;list-style:none;margin:0;padding:0}.mw-parser-output .plainlist ol li,.mw-parser-output .plainlist ul li{margin-bottom:0}</style><div class="plainlist"> <ul><li><small><abbr class="country-name" title="United States">US</abbr></small>&#160;<a href="/wiki/DailyMed" title="DailyMed">DailyMed</a>:&#160;<span title="dailymed.nlm.nih.gov"><a rel="nofollow" class="external text" href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&amp;query=Nemolizumab">Nemolizumab</a></span></li></ul></div> </td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Route_of_administration" title="Route of administration">Routes of<br />administration</a></th><td class="infobox-data"><a href="/wiki/Subcutaneous_injection" class="mw-redirect" title="Subcutaneous injection">Subcutaneous injection</a></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Anatomical_Therapeutic_Chemical_Classification_System" title="Anatomical Therapeutic Chemical Classification System">ATC code</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><a href="/wiki/ATC_code_D11" title="ATC code D11">D11AH12</a>&#x20;(<span title="www.whocc.no"><a rel="nofollow" class="external text" href="https://www.whocc.no/atc_ddd_index/?code=D11AH12">WHO</a></span>)&#x20;</li></ul></div></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;">Legal status</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">Legal status</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"> <ul><li><small><abbr class="country-name" title="United States">US</abbr>:</small>&#x20;<a href="/wiki/Prescription_drug" title="Prescription drug">℞-only</a><sup id="cite_ref-Nemluvio_FDA_label_1-0" class="reference"><a href="#cite_note-Nemluvio_FDA_label-1"><span class="cite-bracket">&#91;</span>1<span class="cite-bracket">&#93;</span></a></sup></li> <li><small><abbr class="country-name" title="European Union">EU</abbr>:</small>&#x20;Rx-only<sup id="cite_ref-Nemluvio_EPAR_2-0" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-Nemluvio_PI_3-0" class="reference"><a href="#cite_note-Nemluvio_PI-3"><span class="cite-bracket">&#91;</span>3<span class="cite-bracket">&#93;</span></a></sup></li></ul></div> </td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;"><a href="/wiki/Pharmacokinetics" title="Pharmacokinetics">Pharmacokinetic</a> data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Drug_metabolism" title="Drug metabolism">Metabolism</a></th><td class="infobox-data"><a href="/wiki/Proteolytic_enzyme" class="mw-redirect" title="Proteolytic enzyme">Proteolytic enzymes</a></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;">Identifiers</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/CAS_Registry_Number" title="CAS Registry Number">CAS Number</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="commonchemistry.cas.org"><a rel="nofollow" class="external text" href="https://commonchemistry.cas.org/detail?cas_rn=1476039-58-3">1476039-58-3</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/DrugBank" title="DrugBank">DrugBank</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.drugbank.ca"><a rel="nofollow" class="external text" href="https://www.drugbank.ca/drugs/DB15252">DB15252</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/ChemSpider" title="ChemSpider">ChemSpider</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li>none</li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Unique_Ingredient_Identifier" title="Unique Ingredient Identifier">UNII</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="precision.fda.gov"><a rel="nofollow" class="external text" href="https://precision.fda.gov/uniisearch/srs/unii/GN465U8B72">GN465U8B72</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/KEGG" title="KEGG">KEGG</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.kegg.jp"><a rel="nofollow" class="external text" href="https://www.kegg.jp/entry/D11080">D11080</a></span></li></ul></div></td></tr></tbody></table> <p><b>Nemolizumab</b>, sold under the brand name <b>Nemluvio</b>, is a <a href="/wiki/Humanized_monoclonal_antibody" class="mw-redirect" title="Humanized monoclonal antibody">humanized monoclonal antibody</a> used for the treatment of <a href="/wiki/Prurigo_nodularis" title="Prurigo nodularis">prurigo nodularis</a> and <a href="/wiki/Atopic_dermatitis" title="Atopic dermatitis">atopic dermatitis</a>.<sup id="cite_ref-Nemluvio_FDA_label_1-1" class="reference"><a href="#cite_note-Nemluvio_FDA_label-1"><span class="cite-bracket">&#91;</span>1<span class="cite-bracket">&#93;</span></a></sup> It is a <a href="/wiki/Monoclonal_antibody" title="Monoclonal antibody">monoclonal antibody</a> that blocks the <a href="/wiki/Interleukin-31_receptor_A" class="mw-redirect" title="Interleukin-31 receptor A">interleukin-31 receptor A</a>.<sup id="cite_ref-Nemluvio_FDA_label_1-2" class="reference"><a href="#cite_note-Nemluvio_FDA_label-1"><span class="cite-bracket">&#91;</span>1<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-FDA_Snapshot_4-0" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> Nemolizumab is humanized IgG2 monoclonal antibody that inhibits interleukin-31 signaling by binding selectively to interleukin-31 receptor alpha.<sup id="cite_ref-Nemluvio_EPAR_2-1" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup> It is an interleukin-31 receptor antagonist.<sup id="cite_ref-Nemluvio_FDA_label_1-3" class="reference"><a href="#cite_note-Nemluvio_FDA_label-1"><span class="cite-bracket">&#91;</span>1<span class="cite-bracket">&#93;</span></a></sup> IL-31 is a cytokine involved in pruritus, inflammation, epidermal dysregulation and fibrosis.<sup id="cite_ref-Nemluvio_EPAR_2-2" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup> By inhibiting IL-31-induced responses, nemolizumab prevents the release of proinflammatory cytokines and chemokines.<sup id="cite_ref-Nemluvio_EPAR_2-3" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup> </p><p>Nemolizumab was approved for medical use in the United States in August 2024,<sup id="cite_ref-FDA_Snapshot_4-1" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-Drug_Approval_Package:_Nemluvio_5-0" class="reference"><a href="#cite_note-Drug_Approval_Package:_Nemluvio-5"><span class="cite-bracket">&#91;</span>5<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-Novel_Drug_Approvals_for_2024_6-0" class="reference"><a href="#cite_note-Novel_Drug_Approvals_for_2024-6"><span class="cite-bracket">&#91;</span>6<span class="cite-bracket">&#93;</span></a></sup> and in the European Union in February 2025.<sup id="cite_ref-Nemluvio_EPAR_2-4" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-Nemluvio_PI_3-1" class="reference"><a href="#cite_note-Nemluvio_PI-3"><span class="cite-bracket">&#91;</span>3<span class="cite-bracket">&#93;</span></a></sup> The US <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (FDA) considers it to be a <a href="/wiki/First-in-class_medication" title="First-in-class medication">first-in-class medication</a>.<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">&#91;</span>7<span class="cite-bracket">&#93;</span></a></sup> </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Medical_uses">Medical uses</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Nemolizumab&amp;action=edit&amp;section=1" title="Edit section: Medical uses"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Nemolizumab is <a href="/wiki/Indicated" class="mw-redirect" title="Indicated">indicated</a> for the treatment of adults with <a href="/wiki/Prurigo_nodularis" title="Prurigo nodularis">prurigo nodularis</a>.<sup id="cite_ref-Nemluvio_FDA_label_1-4" class="reference"><a href="#cite_note-Nemluvio_FDA_label-1"><span class="cite-bracket">&#91;</span>1<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-FDA_Snapshot_4-2" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> In December 2024, the indication for nemolizumab was updated to include the treatment of people twelve years of age and older with moderate-to-severe <a href="/wiki/Atopic_dermatitis" title="Atopic dermatitis">atopic dermatitis</a> in combination with topical <a href="/wiki/Corticosteroid" title="Corticosteroid">corticosteroids</a> and/or <a href="/wiki/Calcineurin_inhibitor" class="mw-redirect" title="Calcineurin inhibitor">calcineurin inhibitors</a> when the disease is not adequately controlled with topical prescription therapies.<sup id="cite_ref-Nemluvio_FDA_label_1-5" class="reference"><a href="#cite_note-Nemluvio_FDA_label-1"><span class="cite-bracket">&#91;</span>1<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-FDA_Snapshot_4-3" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">&#91;</span>8<span class="cite-bracket">&#93;</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Nemolizumab&amp;action=edit&amp;section=2" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Nemolizumab was invented by <a href="/wiki/Chugai" class="mw-redirect" title="Chugai">Chugai</a>, who sold an exclusive license for the drug's development and worldwide marketing (except Japan and Taiwan) to <a href="/wiki/Galderma" title="Galderma">Galderma</a> in 2016.<sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">&#91;</span>9<span class="cite-bracket">&#93;</span></a></sup> </p><p>The US <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (FDA) approved nemolizumab for the treatment of prurigo nodularis based on evidence from two clinical trials (OLYMPIA 1 and OLYMPIA 2) of 560 participants with prurigo nodularis.<sup id="cite_ref-FDA_Snapshot_4-4" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> The trials were conducted at 132 sites in 16 countries including Austria, Belgium, Canada, Denmark, France, Netherlands, Germany, Hungary, Italy, Poland, South Korea, Spain, Sweden, Switzerland, the United Kingdom, and the United States.<sup id="cite_ref-FDA_Snapshot_4-5" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> The trials included 99 participants inside the United States.<sup id="cite_ref-FDA_Snapshot_4-6" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> Among the 560 enrolled participants, all of them were evaluated for efficacy (intent-to-treat population) and 556 participants were evaluated for safety.<sup id="cite_ref-FDA_Snapshot_4-7" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> In both trials, participants with prurigo nodularis were randomized to receive nemolizumab or placebo.<sup id="cite_ref-FDA_Snapshot_4-8" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> Participants weighing less than 90 kilograms (200&#160;lb) in the nemolizumab group received subcutaneous injections of nemolizumab 60<span class="nowrap">&#160;</span>mg at week 0, followed by 30<span class="nowrap">&#160;</span>mg injections every four weeks.<sup id="cite_ref-FDA_Snapshot_4-9" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> Participants weighing 90 kilograms (200&#160;lb) or more in the nemolizumab group received subcutaneous injections of nemolizumab 60<span class="nowrap">&#160;</span>mg at week 0 and every four weeks.<sup id="cite_ref-FDA_Snapshot_4-10" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Society_and_culture">Society and culture</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Nemolizumab&amp;action=edit&amp;section=3" title="Edit section: Society and culture"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Legal_status">Legal status</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Nemolizumab&amp;action=edit&amp;section=4" title="Edit section: Legal status"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Nemolizumab was approved for medical use in the United States in August 2024.<sup id="cite_ref-FDA_Snapshot_4-11" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-Drug_Approval_Package:_Nemluvio_5-1" class="reference"><a href="#cite_note-Drug_Approval_Package:_Nemluvio-5"><span class="cite-bracket">&#91;</span>5<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-Novel_Drug_Approvals_for_2024_6-1" class="reference"><a href="#cite_note-Novel_Drug_Approvals_for_2024-6"><span class="cite-bracket">&#91;</span>6<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">&#91;</span>10<span class="cite-bracket">&#93;</span></a></sup> The FDA granted the application <a href="/wiki/Breakthrough_therapy" title="Breakthrough therapy">breakthrough therapy</a> designation.<sup id="cite_ref-CY_2024_CDER_Breakthrough_Therapy_Calendar_Year_Approvals_11-0" class="reference"><a href="#cite_note-CY_2024_CDER_Breakthrough_Therapy_Calendar_Year_Approvals-11"><span class="cite-bracket">&#91;</span>11<span class="cite-bracket">&#93;</span></a></sup> </p><p>In December 2024, the <a href="/wiki/Committee_for_Medicinal_Products_for_Human_Use" title="Committee for Medicinal Products for Human Use">Committee for Medicinal Products for Human Use</a> of the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Nemluvio, intended for the treatment of atopic dermatitis and prurigo nodularis.<sup id="cite_ref-Nemluvio_EPAR_2-5" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup> The applicant for this medicinal product is Galderma International.<sup id="cite_ref-Nemluvio_EPAR_2-6" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-12" class="reference"><a href="#cite_note-12"><span class="cite-bracket">&#91;</span>12<span class="cite-bracket">&#93;</span></a></sup> Nemolizumab was authorized for medical use in the European Union in February 2025.<sup id="cite_ref-Nemluvio_EPAR_2-7" class="reference"><a href="#cite_note-Nemluvio_EPAR-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-Nemluvio_PI_3-2" class="reference"><a href="#cite_note-Nemluvio_PI-3"><span class="cite-bracket">&#91;</span>3<span class="cite-bracket">&#93;</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Names">Names</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Nemolizumab&amp;action=edit&amp;section=5" title="Edit section: Names"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Nemolizumab is the <a href="/wiki/International_nonproprietary_name" title="International nonproprietary name">international nonproprietary name</a>.<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">&#91;</span>13<span class="cite-bracket">&#93;</span></a></sup> </p><p>Nemolizumab is sold under the brand name Nemluvio.<sup id="cite_ref-FDA_Snapshot_4-12" class="reference"><a href="#cite_note-FDA_Snapshot-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Nemolizumab&amp;action=edit&amp;section=6" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output 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.cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9229ef1-ac60-4c24-afb6-009d3c781687">"Nemluvio- nemolizumab-ilto injection, powder, lyophilized, for solution"</a>. <i>DailyMed</i>. 13 August 2024<span class="reference-accessdate">. Retrieved <span class="nowrap">5 September</span> 2024</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=DailyMed&amp;rft.atitle=Nemluvio-+nemolizumab-ilto+injection%2C+powder%2C+lyophilized%2C+for+solution&amp;rft.date=2024-08-13&amp;rft_id=https%3A%2F%2Fdailymed.nlm.nih.gov%2Fdailymed%2FdrugInfo.cfm%3Fsetid%3De9229ef1-ac60-4c24-afb6-009d3c781687&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ANemolizumab" class="Z3988"></span></span> </li> <li id="cite_note-Nemluvio_EPAR-2"><span class="mw-cite-backlink">^ <a href="#cite_ref-Nemluvio_EPAR_2-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-Nemluvio_EPAR_2-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-Nemluvio_EPAR_2-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-Nemluvio_EPAR_2-3"><sup><i><b>d</b></i></sup></a> <a href="#cite_ref-Nemluvio_EPAR_2-4"><sup><i><b>e</b></i></sup></a> <a href="#cite_ref-Nemluvio_EPAR_2-5"><sup><i><b>f</b></i></sup></a> <a href="#cite_ref-Nemluvio_EPAR_2-6"><sup><i><b>g</b></i></sup></a> <a href="#cite_ref-Nemluvio_EPAR_2-7"><sup><i><b>h</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/medicines/human/EPAR/nemluvio">"Nemluvio EPAR"</a>. <i><a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA)</i>. 12 December 2024<span class="reference-accessdate">. Retrieved <span class="nowrap">13 December</span> 2024</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=European+Medicines+Agency+%28EMA%29&amp;rft.atitle=Nemluvio+EPAR&amp;rft.date=2024-12-12&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fnemluvio&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ANemolizumab" class="Z3988"></span> Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</span> </li> <li id="cite_note-Nemluvio_PI-3"><span class="mw-cite-backlink">^ <a href="#cite_ref-Nemluvio_PI_3-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-Nemluvio_PI_3-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-Nemluvio_PI_3-2"><sup><i><b>c</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://ec.europa.eu/health/documents/community-register/html/h1901.htm">"Nemluvio PI"</a>. <i>Union Register of medicinal products</i>. 13 February 2025<span class="reference-accessdate">. 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Retrieved <span class="nowrap">19 April</span> 2017</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.atitle=Chugai+grants+exclusive+global+license+for+development+and+marketing+of+nemolizumab+to+Galderma&amp;rft.date=2016-07-22&amp;rft_id=http%3A%2F%2Fwww.pharmabiz.com%2FArticleDetails.aspx%3Faid%3D96389%26sid%3D2&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ANemolizumab" class="Z3988"></span></span> </li> <li id="cite_note-10"><span class="mw-cite-backlink"><b><a href="#cite_ref-10">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation pressrelease cs1"><a rel="nofollow" class="external text" href="https://www.businesswire.com/news/home/20240812791599/en/">"Galderma Receives U.S. FDA Approval for Nemluvio (nemolizumab) for Adult Patients Living With Prurigo Nodularis"</a> (Press release). 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(October 2023). "Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis". <i>The New England Journal of Medicine</i>. <b>389</b> (17): <span class="nowrap">1579–</span>1589. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1056%2FNEJMoa2301333">10.1056/NEJMoa2301333</a>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a>&#160;<a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/37888917">37888917</a>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.jtitle=The+New+England+Journal+of+Medicine&amp;rft.atitle=Phase+3+Trial+of+Nemolizumab+in+Patients+with+Prurigo+Nodularis&amp;rft.volume=389&amp;rft.issue=17&amp;rft.pages=%3Cspan+class%3D%22nowrap%22%3E1579-%3C%2Fspan%3E1589&amp;rft.date=2023-10&amp;rft_id=info%3Adoi%2F10.1056%2FNEJMoa2301333&amp;rft_id=info%3Apmid%2F37888917&amp;rft.aulast=Kwatra&amp;rft.aufirst=SG&amp;rft.au=Yosipovitch%2C+G&amp;rft.au=Legat%2C+FJ&amp;rft.au=Reich%2C+A&amp;rft.au=Paul%2C+C&amp;rft.au=Simon%2C+D&amp;rft.au=Naldi%2C+L&amp;rft.au=Lynde%2C+C&amp;rft.au=De+Bruin-Weller%2C+MS&amp;rft.au=Nahm%2C+WK&amp;rft.au=Sauder%2C+M&amp;rft.au=Gharib%2C+R&amp;rft.au=Barbarot%2C+S&amp;rft.au=Szepietowski%2C+JC&amp;rft.au=Conrad%2C+C&amp;rft.au=Fleischer%2C+A&amp;rft.au=Laquer%2C+VT&amp;rft.au=Misery%2C+L&amp;rft.au=Serra-Baldrich%2C+E&amp;rft.au=Lapeere%2C+H&amp;rft.au=Ahmad%2C+F&amp;rft.au=Jabbar+Lopez%2C+ZK&amp;rft.au=Piketty%2C+C&amp;rft.au=St%C3%A4nder%2C+S&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ANemolizumab" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFSilverbergWollenbergReichThaçi2024" class="citation journal cs1">Silverberg JI, Wollenberg A, Reich A, Thaçi D, Legat FJ, Papp KA, et&#160;al. 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"Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials". <i>Lancet</i>. <b>404</b> (10451): <span class="nowrap">445–</span>460. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1016%2FS0140-6736%2824%2901203-0">10.1016/S0140-6736(24)01203-0</a>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a>&#160;<a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/39067461">39067461</a>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.jtitle=Lancet&amp;rft.atitle=Nemolizumab+with+concomitant+topical+therapy+in+adolescents+and+adults+with+moderate-to-severe+atopic+dermatitis+%28ARCADIA+1+and+ARCADIA+2%29%3A+results+from+two+replicate%2C+double-blind%2C+randomised+controlled+phase+3+trials&amp;rft.volume=404&amp;rft.issue=10451&amp;rft.pages=%3Cspan+class%3D%22nowrap%22%3E445-%3C%2Fspan%3E460&amp;rft.date=2024-08&amp;rft_id=info%3Adoi%2F10.1016%2FS0140-6736%2824%2901203-0&amp;rft_id=info%3Apmid%2F39067461&amp;rft.aulast=Silverberg&amp;rft.aufirst=JI&amp;rft.au=Wollenberg%2C+A&amp;rft.au=Reich%2C+A&amp;rft.au=Tha%C3%A7i%2C+D&amp;rft.au=Legat%2C+FJ&amp;rft.au=Papp%2C+KA&amp;rft.au=Stein+Gold%2C+L&amp;rft.au=Bouaziz%2C+JD&amp;rft.au=Pink%2C+AE&amp;rft.au=Carrascosa%2C+JM&amp;rft.au=Rewerska%2C+B&amp;rft.au=Szepietowski%2C+JC&amp;rft.au=Krasowska%2C+D&amp;rft.au=Havl%C3%AD%C4%8Dkov%C3%A1%2C+B&amp;rft.au=Kalowska%2C+M&amp;rft.au=Magnolo%2C+N&amp;rft.au=Pauser%2C+S&amp;rft.au=Nami%2C+N&amp;rft.au=Sauder%2C+MB&amp;rft.au=Jain%2C+V&amp;rft.au=Padlewska%2C+K&amp;rft.au=Cheong%2C+SY&amp;rft.au=Fleuranceau+Morel%2C+P&amp;rft.au=Ulianov%2C+L&amp;rft.au=Piketty%2C+C&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ANemolizumab" class="Z3988"></span></li></ul> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Nemolizumab&amp;action=edit&amp;section=8" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li>Clinical trial number <i><a rel="nofollow" class="external text" href="https://www.clinicaltrials.gov/show/NCT04501666">NCT04501666</a></i> for "Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)" at <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a></li> <li>Clinical trial number <i><a rel="nofollow" class="external text" href="https://www.clinicaltrials.gov/show/NCT04501679">NCT04501679</a></i> for "A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)" at <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a></li> <li>Clinical trial number <i><a rel="nofollow" class="external text" href="https://www.clinicaltrials.gov/show/NCT03985943">NCT03985943</a></i> for "Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis" at <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a></li> <li>Clinical trial number <i><a rel="nofollow" class="external text" href="https://www.clinicaltrials.gov/show/NCT03989349">NCT03989349</a></i> for "Efficacy &amp; Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis" at <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a></li></ul> <div class="navbox-styles"><style data-mw-deduplicate="TemplateStyles:r1129693374">.mw-parser-output .hlist dl,.mw-parser-output .hlist ol,.mw-parser-output .hlist ul{margin:0;padding:0}.mw-parser-output .hlist dd,.mw-parser-output .hlist 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