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Orphanet : Search for an orphan drug

<!DOCTYPE html> <html lang="en"> <head> <script src="https://tarteaucitron.io/load.js?domain=www.orpha.net&uuid=bf83258dd5f3bc0f8040bc1a95eedc2ec3ca1a62"></script> <meta charset="UTF-8"> <meta name="viewport" content="width=device-width, initial-scale=1"> <meta name="google-site-verification" content="9sM3zazZuWJ_PI134Dxgq_MqlUEWRYULwgLG7sAaZ4w" > <title>Orphanet : Search for an orphan drug</title> <link rel="shortcut icon" href="/build/images/favicon.png" type="image/png" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-VY3XS4G203"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'G-VY3XS4G203'); </script> <link rel="stylesheet" href="/build/app.c889ea47.css"> </head> <body> <header class="menu d-print-none"> <div class="fixed-top container-fluid d-flex justify-content-between p-0"> <nav> <a href="#menu" class="d-inline-block h-100"> <div class="burger-button closed h-100 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col-9 row d-lg-flex d-none px-3 py-5"> <div class="col-6 pe-lg-4"> <div class="border-end border-1 border-dark"> <h5 class="orpha-blue fw-bold">Orphanet produces its data according to published procedures</h5> <a class="btn-blue mt-3" href="/en/other-information/procedures">Read</a> </div> </div> <div class="col-6 ps-lg-4 news-menu"> <ul class="list-unstyled mx-auto"> <li><a class="orpha-blue fw-bold" href="//ec.europa.eu/health-eu/health_problems/rare_diseases/index_en.html" title="Rare Diseases - European Commission">Rare Diseases - European Commission</a></li> <li><a class="orpha-blue fw-bold" href="//www.rd-action.eu/" title="RD-Action">RD-Action</a></li> <li><a class="orpha-blue fw-bold" href="//www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/orphan_search.jsp&mid=WC0b01ac058001d12b" title="European Medicines Agency">European Medicines Agency</a></li> <li><a class="orpha-blue fw-bold" href="//www.irdirc.org/" title="IRDiRC">IRDiRC</a></li> <li><a class="orpha-blue 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border-orpha-news border-4 border"> <a href="//international.orphanews.org/" class="text-white h2 text-decoration-none align-self-center px-5 py-3"> <img class="align-self-center" height="45" alt="Read OrphaNews" src="/build/images/logo-orphanews.png"> </a> </div> <div class="col-lg-4 col-12 row text-center opacity-hover border-orpha-data border-4 border"> <a href="//www.orphadata.com/" class="text-white h2 text-decoration-none align-self-center px-5 py-3"> <img class="align-self-center" height="45" alt="Access Orphadata" src="/build/images/logo-orphadata.png"> </a> </div> <div class="col-lg-4 col-12 row text-center opacity-hover border-blue border-4 border"> <a href="//www.orphadata.com/ontologies/" class="text-white h2 text-decoration-none align-self-center px-5 py-3"> <img class="align-self-center" height="45" alt="Access ORDO" src="/build/images/logo-ordo.png"> </a> </div> </div> </nav> <div class="modal fade " id="socialShare" tabindex="-1" aria-labelledby="socialShare" aria-hidden="true"> <div class="modal-dialog"> <div class="modal-content rounded-0"> <div class="modal-header p-0 justify-content-end"> <div type="button" class="text-white bg-orpa-blue py-1 px-3 fs-4" data-bs-dismiss="modal" aria-label="Close">X</div> </div> <div class="modal-body"> <ul class="list-unstyled text-center"> <li class="mb-4"> <a class="orpha-blue" href="https://www.twitter.com/share?url=http://www.orpha.net/en/drug" target="_blank" title="Share"> <i class="fab fa-lg fa-twitter"></i> Share</a> </li> <li> <a class="orpha-blue" href="https://www.facebook.com/sharer/sharer.php?u=http://www.orpha.net/en/drug" target="_blank" title="Share"> <i class="fab fa-lg fa-facebook-square"></i> Share</a> </li> </ul> </div> </div> </div> </div> </header> <main class="container-fluid p-0"> <article class="drugs w-100 py-5"> <header class="row-fluid text-center"> <div class="col-12 my-4"> <div class="current-event"> <div class="mt-5 d-flex justify-content-center"> <div class="bandeau-search"> <a href="https://don.telethon.fr/"> <img src="/images/banner.png" alt="Telethon 2024" class="img-fluid" /> </a> </div> </div> <h1 class="current-image-title mb-0">Knowledge on <strong>rare diseases</strong> and <strong>orphan drugs</strong></h1> <a class="orpha-blue small text-decoration-underline" href="http://international.orphanews.org/summary/editorial/nl/id-200327.html" target="_blank" title="COVID-19 & Rare diseases"> COVID-19 & Rare diseases </a> <img class="img-fluid" alt="logo" src="/build/images/logoMain.png" width="4%"> <a class="orpha-blue small text-decoration-underline" href="https://international.orphanews.org/newsletter-en/editorial/nl/en20200314.html#or_resources-for-refugees-and-displaced-persons-with-rare-diseasesFR/IP_22_1469" target="_blank" title="Rare Diseases Resources for Refugees/Displaced Persons"> Rare Diseases Resources for Refugees/Displaced Persons </a> </div> </div> </header> <article class="row gx-0 gb-2"> <div class="col-xxl-9 col-lg-11 col-11 mx-auto service-wrapper pb-5"> <header class="row g-0 mb-4"> <aside class="d-none d-sm-none d-lg-block col-2"> <div class="h-100 w-100 d-flex flex-column justify-content-evenly text-center service-card py-4 px-2"> <span class="icon-container"><i class="fas fa-user-md fa-3x"></i></span> <span>Orphan drugs</span> </div> </aside> <div class="col-10"> <div class="h-100 w-100 d-flex flex-column justify-content-evenly ps-4 mt-4 mt-md-0 d-print-none"> <span class="my-sm-3 icon-container"><a href="/">Homepage</a> > <a href="/en/drug">Orphan drugs</a> > <strong><a href="/en/drug">Search</a></strong></span> <h2>Search for an orphan drug</h2> </div> </div> </header> <main class="row g-0"> <nav class="d-none d-sm-none d-lg-block col-2"> <ul class="list-unstyled"> <li class="current"><a target="_self" href=/en/drug> Search</a></li> <li class=""><a target="_self" href=/en/other-information/procedures> Sources/procedures</a></li> <li><a target="_blank" href=//www.orphadata.com/> Download dataset</a></li> <li class=""><a target="_self" href=/en/other-information/reports> Orphanet Reports series</a></li> </ul> </nav> <div class="col-sm-12 col-md-10 col-lg-10 col-xl-10"> <fieldset class="service-color-box align-self-start mx-4 p-3 d-print-none"> <form name="drug_search" method="post" action="/en/drug"> <div class="row"> <span class="dark-red col-md-9 col-xl-10 col-12 text-end">*</span> <div class="col-12 col-xl-10 col-md-9"> <div> <input type="text" id="drug_search_name" name="drug_search[name]" required="required" placeholder="Disease name" class="js-autocomplete form-control" data-autocomplete-url="/en/disease/autocomplete/classifications_ascendants_search_en" /> </div> <small class="dark-red"> (*) mandatory field </small> </div> <div class="col-12 col-xl-2 col-md-3"> <button type="submit" id="drug_search_search" name="drug_search[search]" class="btn-primary btn">Search</button> </div> </div> <div class="row mt-3 mb-1"> <div class="col-12 col-lg-6 mt-2 mt-md-0"> <div id="drug_search_mode"><div class="form-check"><input type="radio" id="drug_search_mode_0" name="drug_search[mode]" required="required" class="form-check-input" value="dsg" /> <label class="form-check-label required" for="drug_search_mode_0">Orphan designation</label></div><div class="form-check"><input type="radio" id="drug_search_mode_1" name="drug_search[mode]" required="required" class="form-check-input" value="mrk" /> <label class="form-check-label required" for="drug_search_mode_1">Marketing authorisation</label></div><div class="form-check"><input type="radio" id="drug_search_mode_2" name="drug_search[mode]" required="required" class="form-check-input" value="markdsg" /> <label class="form-check-label required" for="drug_search_mode_2">Marketing authorisation with orphan designation</label></div><div class="form-check"><input type="radio" id="drug_search_mode_3" name="drug_search[mode]" required="required" class="form-check-input" value="all" checked="checked" /> <label class="form-check-label required" for="drug_search_mode_3">All status</label></div></div> </div> <div class="col-12 col-lg-6 mt-2 mt-md-0"> <select id="drug_search_region" name="drug_search[region]" class="form-select"><option value="">All area</option><option value="Europe">Europe</option><option value="USA">Usa</option></select> </div> </div> </form> <div class="more-options float-md-end float-sm-start"> <label class="fw-bold service-color"> Other search option(s) <span class="up d-none"><i class="fas fa-caret-up"></i></span> <span class="down"><i class="fas fa-caret-up fa-rotate-180"></i></span> </label> <ul class="list-unstyled opacity-0" aria-expanded="false"> <li> <span class="service-color"><i class="fas fa-chevron-right"></i></span> <a href="/en/drug/trade_substance">Search by substance/tradename</a> </li> </ul> </div> </fieldset> <div class="row g-0 mt-5"> <div class="col-12"> <div class="help px-4 mt-1"> <div class="offset-0 col-12 offset-lg-1 col-lg-10 mb-5 mt-4 mt-sm-0"> <h3>Help</h3> <p> <span class="icon-container"><i class="mx-2 fas fa-lg fa-file-pdf"></i></span> <a href="//www.orpha.net/orphacom/cahiers/docs/GB/medicinal_products_in_Orphanet_R2_R_D_Drugs_EP_06.pdf" target="_blank" rel="noopener">Procedures: Data collection and registration of medicinal products intended for rare diseases in Orphanet</a> </p> <p>Orphanet provides an inventory of drugs at all stages of development for one particular rare disease or a group of rare diseases. This includes all the substances which have been granted an <strong>orphan designation</strong> for disease(s) considered as rare in Europe or the USA, whether they were further developed to become approved drugs with <strong>marketing authorisation</strong> (MA) or not. </p> <p>The Orphanet database also includes drugs without an orphan designation as long as they have been granted a marketing authorisation with a specific indication for a rare disease. </p> <p>Some drugs are included in the database because they are tested in a clinical trial or a project research performed on a rare disease, but they do not have a regulatory status. </p> <p class="fw-bold">Search by disease name: Enter your requested disease name to access the list of medicinal products for this disease. We inform you that the names of the substances are presented in English language. </p> <p class="fw-bold">Search by substance/tradename: Enter your requested drug by its commercial name (Tradename) or substance name including INN (International Non-proprietary Name), chemical names, code names of the substance or common names. We inform you that the names of the substances are presented in English language. </p> <p><strong>Orphan designation</strong> is a legal procedure that allows for the designation of a medicinal substance with therapeutic potential for a rare disease, before its first administration in humans or during its clinical development. </p> <p>The exact therapeutic indication is then defined at the time of marketing authorisation. This procedure has been established in Europe by the <a href="//eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:EN:PDF" class="lien_ext" target="_blank" title="Open this link in a new window">Regulation on Orphan Medicinal Products (EC) No 141/2000</a> and in the US by the <a href="//www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/OrphanDrugAct/default.htm" class="lien_ext" target="_blank" title="Open this link in a new window">Orphan Drug Act.</a> </p> <p>You can access related Orphanet datasets in an aggregated format through <a target="" _blank'="" href="//www.orphadata.com/">Orphadata</a> after signature of a Data Transfer Agreement/Service Contract. </p> </div> <div class="warning p-5 mb-5"> <h4><i class="fas fa-sm fa-exclamation-triangle"></i> Warning</h4> <p>Information in Orphanet is updated on a regular basis. It may happen that there is a delay between the granting of a new designations/approvals and their publication in Orphanet. Professionals are always encouraged to consult the most recent publications and official documents such as Committee for Orphan Medicinal Product (COMP) decisions, Summary of Products Characteristics/ Prescribing Information and Health Technology Assessment reports before making any decisions based on the information provided. The Orphanet database aims to provide the best possible representation of the rare diseases for which drugs are developed and/or marketed, based on the information available on the EMA (European Medicines Agency) and FDA (Food and Drug Administration) websites, but it does not replace the public drug databases of the health authorities. </p> <p>Orphanet cannot be held responsible for harmful, truncated or erroneous use of any information found in the Orphanet database. </p> <p>Orphanet acknowledges the contribution of the European Medicines Agency (EMA) to the creation of the database on orphan medicinal products in Europe. This project was initiated by the Committee for Orphan Medicinal Products (COMP) at the EMA. Several members of the COMP have individually contributed to the development of the database, which was welcomed by the COMP as a significant tool for all stakeholders. The database has been developed entirely and autonomously by Orphanet, using public and private funding and publicly available data; as such, neither the EMA nor the COMP are responsible for the content and management of the database. </p> </div> <div class="col-12"> <p>The Orphanet database of orphan drugs was developed with co-funding from the following institutions and companies:</p> <ul class="list-unstyled d-flex justify-content-evenly"> <li> <a target="_blank" href="//www.leem.org/article/fondation-des-entreprises-du-medicament-pour-l-acces-aux-soins"> <img src="/build/images/drugs/logo_LeemFondation-50px.jpg" alt="Leem"> </a> </li> <li> <a target="_blank" href="//www.novartis.com"> <img src="/build/images/drugs/logo-NVS.jpg" alt="//www.novartis.com"> </a> </li> <li> <a target="_blank" href="//www.pfizer.com"> <img src="/build/images/drugs/logo-Pfizer.jpg" alt="//www.pfizer.com"> </a> </li> <li> <a target="_blank" href="//www.merckserono.net"> <img src="/build/images/drugs/logo-Merck-Serono.jpg" alt="//www.merckserono.net"> </a> </li> <li><a target="_blank" href="//www.pharmamar.com/"> <img src="/build/images/drugs/logo-phm.jpg" alt="//www.pharmamar.com/"></a> </li> <li> <a target="_blank" href="//www.genzyme.com"> <img src="/build/images/drugs/logo_genzyme.jpg" alt="//www.genzyme.com"> </a> </li> <li> <a target="_blank" href="//www.genzyme.com"> <img src="/build/images/drugs/logo-biomarin.jpg" alt="//www.genzyme.com"> </a> </li> </ul> </div> </div> </div> </div> </div> </main> </div> </article> </article> </main> <script src="/build/runtime.f3575a88.js" defer></script><script src="/build/755.5a8586e9.js" defer></script><script src="/build/673.f47275b8.js" defer></script><script src="/build/467.7cd7293e.js" defer></script><script src="/build/app.f38c68b0.js" defer></script> <script src="/build/dropdown.3479635d.js" defer></script> </body> <footer> <section class="partners bg-white my-3 d-print-none"> <h3 class="fs-5 text-center orpha-blue fw-bold">With the support of</h3> <div class="row col-lg-10 mx-auto my-4"> <ul class="list-unstyled d-inline-flex col-12 col-lg-6 flex-wrap justify-content-evenly align-items-center border-blue"> <li class="d-inline"> <a title="Site Internet de l'Inserm" href="//www.inserm.fr/" target="_blank"> <img src="/build/images/partners/logo-inserm.png" height="20px" alt="Site Internet de l'Inserm"> </a> </li> <li class="d-inline"> <a title="Link to the French Ministry of Health" href="//www.sante.gouv.fr/" target="_blank"> <img src="/build/images/partners/logo-sante_jeunesse_sports.png" alt="Link to the French Ministry of Health"> </a> </li> <li class="d-inline"> <a title="Link to CEE website" href="//health.ec.europa.eu/rare-diseases-and-european-reference-networks/rare-diseases_en" target="_blank"> <img src="/build/images/partners/logo-CEE_RDPortal.jpg" alt="Link to CEE website"> </a> </li> </ul> <ul class="list-unstyled d-inline-flex col-12 col-lg-6 flex-wrap justify-content-evenly align-items-center"> <li class="d-inline"> <a title="Site Internet de l'AFM" href="//www.afm-telethon.fr" target="_blank"> <img src="/build/images/partners/logo-AFM.jpg" alt="Site Internet de l'AFM"> </a> </li> <li class="d-inline"> <a title="Site Internet de Groupama" href="//www.fondation-groupama.com" target="_blank"> <img style="width:105px;" src="/build/images/partners/groupama.jpg" alt="Site Internet de Groupama"></a> </li> <li class="d-inline"> <a title="Institut fran莽ais de Bioinformatique" href="//www.france-bioinformatique.fr/?q=fr/orphanet" target="_blank"> <img src="/build/images/partners/Institut-Francais-de-Bioinformatique-IFB-petit.png" alt="Institut fran莽ais de Bioinformatique"> </a> </li> </ul> <h3 class="fs-5 text-center orpha-blue fw-bold">Orphanet is recognised as/by</h3> <div class="row col-lg-10 mx-auto my-4"> <ul class="list-unstyled d-inline-flex col-12 flex-wrap justify-content-center align-items-center"> <li class="d-inline me-4"> <a title="information sur le label IRDiRC" href="//www.irdirc.org/activities/irdirc-recognized-resources/" target="_blank"> <img src="/build/images/partners/IRDIRC_logo3-Recomm-Recogn.jpg" alt="information sur le label IRDiRC"> </a> </li> <li class="d-inline me-4"> <a title="HVP Logo" > <img src="/build/images/partners/HVP_Logo.png" alt="HVP Logo"> </a> </li> <li class="d-inline"> <a title="GA4GH Logo" href="//www.ga4gh.org/" target="_blank"> <img src="/build/images/partners/GA_logo_100px.png" alt="GA4GH Logo"> </a> </li> </ul> </div> <h3 class="fs-5 text-center orpha-blue fw-bold">Orphadata Science is recognised as</h3> <div class="row col-lg-10 mx-auto my-4"> <ul class="list-unstyled d-inline-flex col-12 flex-wrap justify-content-center align-items-center"> <li class="d-inline me-4"> <a title="ELIXIR Core Resource Logo" href="//www.elixir-europe.org/platforms/data/core-data-resources" target="_blank"> <img src="/build/images/partners/Logo_CDR-mini.png" alt="ELIXIR Core Resource Logo"> </a> </li> <li class="d-inline"> <a title="Site Internet de globalbiodata" href="https://globalbiodata.org/what-we-do/global-core-biodata-resources/" target="_blank"> <img src="/build/images/partners/gcbr-logo.jpg" alt="Site Internet de globalbiodata"> </a> </li> </ul> </div> </div> </section> <div class="row fs-8 col-lg-7 mx-auto pb-4 pt-2 d-print-none"> <div class="col-10 offset-1 p-0 offset-lg-0 col-sm-6 col-lg-4"> <p>Our Website does not host any form of advertising<br>Our partnerships do not influence our editorial policy</p> <p> 漏 everythingpossible / Fotolia <br> 漏 Orphanet version 1.0.27 - Last updated:<br> 2024-11-14 </p> </div> <div class="appli p-0 col-10 offset-1 offset-md-0 col-sm-1 offset-lg-2 col-lg-1"> <a title="Orphanet, the mobile portal for rare diseases - MOBILE HEALTH" href="//apps.apple.com/lr/app/orphanet-guides/id1580945870" target="itunes_store"> <img src="/build/images/ios.gif" alt="Orphanet, the mobile portal for rare diseases - MOBILE HEALTH"> </a> </div> 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