Minoryx official website

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<div class="m-ppal"> <div class="sta-hoverMobile"> <a href="javascript:openLink('/our-company/')" title="Our Company">Our Company <span class="minusplus"><i class="plus"></i></span><span class="minusplus"><i class="minus"></i></span></a> <div class="m-submenu sta-hoverOFF"> <a href="/our-company/" title="Who we are">Who we are</a><a href="/management-team/" title="Management team">Management team</a><a href="/board-directors/" title="Board of directors">Board of directors</a><a href="/funding/" title="Funding">Funding</a></div> </div> <div class="sta-hoverMobile"> <a href="javascript:openLink('/our-science-overview/')" title="Our Science">Our Science <span class="minusplus"><i class="plus"></i></span><span class="minusplus"><i class="minus"></i></span></a> <div class="m-submenu sta-hoverOFF"> <a href="/our-science-overview/" title="Overview">Overview</a><a href="/adrenoleukodystrophy-orphan-disease/" title="Adrenoleukodystrophy">Adrenoleukodystrophy</a><a href="/friedreich-ataxia-orphan-disease/" title="Other CNS diseases">Other CNS diseases</a></div> </div> <div class="sta-hoverMobile"> <a href="javascript:openLink('/our-pipeline-overview/')" title="Our Programs">Our Programs <span class="minusplus"><i class="plus"></i></span><span class="minusplus"><i class="minus"></i></span></a> <div class="m-submenu sta-hoverOFF"> <a href="/our-pipeline-overview/" title="Overview">Overview</a><a href="/leriglitazone/" title="Leriglitazone">Leriglitazone</a></div> </div> <div class="sta-hoverMobile"> <a href="javascript:openLink('/clinical-studies/')" title="Clinical Studies">Clinical Studies <span class="minusplus"><i class="plus"></i></span><span class="minusplus"><i class="minus"></i></span></a> <div class="m-submenu sta-hoverOFF"> <a href="/clinical-studies/" class="tablet-only">Clinical Studies</a> <a href="/clinical-studies/clincal-study-calyx/" title="CALYX">CALYX</a><a href="/clinical-studies/clinical-study-nexus/" title="NEXUS">NEXUS</a><a href="/clinical-studies/clinical-study-advance/" title="ADVANCE">ADVANCE</a><a href="/clinical-studies/clinical-study-frames/" title="Other Clinical Studies">Other Clinical Studies</a><a href="/clinical-studies/resources/" title="Resources">Resources</a><a href="/clinical-studies/expanded-access-policy/" title="Expanded Access Policy">Expanded Access Policy</a></div> </div> </div> <div class="m-sec"> <div class="sta-hoverMobile"><a href="/news/" title="Media">Media</a> </div> <div class="sta-hoverMobile"><a href="/careers/" title="Careers">Careers</a> </div> </div> </div> <div class="m-redes"><header>Follow us</header> <div> <a href="https://www.linkedin.com/company/minoryx-therapeutics/" class="fa fa-linkedin" target="_blank" rel="noopener noreferrer"></a></div></div> <a href="/contact/" class="m-contact sta-hoverOFF m-boton2"><i></i><i></i><i></i><i></i>Contact</a> </nav></div> <div class="m-slider"> <div class="m-item deferbg" data-mobile="/content/imgsxml/panel_hero/mob-header963.jpg" data-tablet="/content/imgsxml/panel_hero/tab-header963.jpg" data-desktop="/content/imgsxml/panel_hero/header963.jpg"> <div class="m-cover"> <div class="m-info"> <div class="m-inter"> <div class="m-txt"> <header><h1>Bringing new hope for people suffering from orphan CNS diseases</h1></header> <div class="m-texto"><h2 style="text-align: justify;">At Minoryx, we are committed to making innovative treatments available for patients suffering from life threatening orphan diseases.</h2></div> </div> <a class="m-boton sta-hoverOFF" href="/our-company/" target="_self"><i></i><i></i><i></i><i></i>Read more</a> </div> </div> </div> </div></div> <a class="m-logo" href="/"><img src="/content/imgs/logo.png" alt="Minoryx"></a> </section></li> </ul> <ul id="panel_destacado0_1" class="panel_destacado"> <li data-index="0" id="panel_destacado_item11_1" class="item col-0 clearfix"><section class="mdl-destacado"> <article> <div class="m-content"> <div class="m-image deferbg" data-mobile="/content/imgsxml/panel_destacado/home-2a822.jpg" data-tablet="/content/imgsxml/panel_destacado/home-2a822.jpg" data-desktop="/content/imgsxml/panel_destacado/home-2a822.jpg"> <img src="/content/imgs/white.png" class="deferimg" data-mobile="/content/imgsxml/panel_destacado/home-2a822.jpg" data-tablet="/content/imgsxml/panel_destacado/home-2a822.jpg" data-desktop="/content/imgsxml/panel_destacado/home-2a822.jpg" alt="" title="" > </div> <div class="m-texto"> <div> <div class="m-pre" data-mod="titulo"><div>Orphan CNS diseases</div></div> <div class="m-title"><div>Leveraging solutions for patients </div></div> <div class="m-text"><p style="text-align: justify;">Minoryx is focused on the discovery and development of novel treatments for severe, orphan diseases of the central nervous system (CNS) with high unmet medical need.</p></div> </div> <div> <div class="m-button"><a class="m-boton sta-hoverOFF" href="/clinical-studies/" target="_self"><i></i><i></i><i></i><i></i>Read more</a></div> </div> </div> </article> </section></li> </ul> <ul id="panel_slider0_2" class="panel_slider"> <li data-index="0" id="panel_slider_item12_2" class="item col-0 clearfix"><section class="mdl-slider"> <div class="m-slider"> <div class="m-item m-round"> <div class="m-cont"> <div class="m-texto"> <div class="m-top"> <div class="m-pre"><div>Our Science </div></div> </div> <div class="m-bot"> <div class="m-title"><div>Our leading program is a novel, selective PPAR gamma agonist</div></div> <div class="m-text"><p style="text-align: justify;">We have discovered and developed a novel, selective PPAR gamma agonist, leriglitazone, which is currently in clinical development for multiple orphan CNS disorders. The lead indication for leriglitazone is X-linked Adrenoleukodystrophy, a devastating neurodegenerative disease that exists in two forms: a chronic form, adrenomyeloneuropathy (AMN) and an acute form, cerebral ALD (cALD).</p> <p style="text-align: justify;">Leriglitazone demonstrated robust preclinical proof-of-concept in relevant animal models of disease and successfully completed phase 1 clinical trials. Leriglitazone completed a<strong> phase 2/3 study in X-ALD (ADVANCE)</strong> in the EU and US showing a significant reduction of cerebral lesion progression and a reduction of incidences of cerebral lesions and myelopathy symptoms. Additionally, a <strong>separate study in paediatric cALD (NEXUS)</strong> is currently ongoing in EU and after 24 weeks of treatement, all evaluable patients in NEXUS were clinically stable and radiologically demonstrated disease arrest or lesion growth stabilization. Finnaly, a <strong>phase 3 study in adult male patients with progressive cALD (CALYX)</strong> is currently recruiting in the US. The marketing authorization application (MAA) for adult male X-ALD patients is currently under review by the EMA.</p> <p style="text-align: justify;">Leriglitazone offers a strong potential for indication expansion into other CNS diseases. In this regard, a proof of concept study in Friedreich's Ataxia (FRDA) showed clinical benefit in this population.</p></div> <div class="m-button"><a class="m-boton sta-hoverOFF" href="/our-science-overview/" target="_self"><i></i><i></i><i></i><i></i>Read more</a></div> </div> </div> <div class="m-image deferbg" data-mobile="/content/imgsxml/panel_slider/m-neurone-darkblue319.jpg" data-tablet="/content/imgsxml/panel_slider/t-neurone-darkblue319.jpg" data-desktop="/content/imgsxml/panel_slider/neurone-darkblue319.jpg"> <img src="/content/imgs/white.png" class="deferimg" data-mobile="/content/imgsxml/panel_slider/m-neurone-darkblue319.jpg" data-tablet="/content/imgsxml/panel_slider/t-neurone-darkblue319.jpg" data-desktop="/content/imgsxml/panel_slider/neurone-darkblue319.jpg" alt="" title="" > </div> </div> <div class="m-cont-mobile"> <div class="m-mobile-top"> <div class="m-texto"> <div class="m-top"> <div class="m-pre"><div>Our Science </div></div> </div> </div> <div class="m-image deferbg" data-mobile="/content/imgsxml/panel_slider/m-neurone-darkblue319.jpg" data-tablet="/content/imgsxml/panel_slider/t-neurone-darkblue319.jpg" data-desktop="/content/imgsxml/panel_slider/neurone-darkblue319.jpg"> <img src="/content/imgs/white.png" class="deferimg" data-mobile="/content/imgsxml/panel_slider/m-neurone-darkblue319.jpg" data-tablet="/content/imgsxml/panel_slider/t-neurone-darkblue319.jpg" data-desktop="/content/imgsxml/panel_slider/neurone-darkblue319.jpg" alt="" title="" > </div> </div> <div class="m-mobile-bot"> <div class="m-title"><div>Our leading program is a novel, selective PPAR gamma agonist</div></div> <div class="m-text"><p style="text-align: justify;">We have discovered and developed a novel, selective PPAR gamma agonist, leriglitazone, which is currently in clinical development for multiple orphan CNS disorders. The lead indication for leriglitazone is X-linked Adrenoleukodystrophy, a devastating neurodegenerative disease that exists in two forms: a chronic form, adrenomyeloneuropathy (AMN) and an acute form, cerebral ALD (cALD).</p> <p style="text-align: justify;">Leriglitazone demonstrated robust preclinical proof-of-concept in relevant animal models of disease and successfully completed phase 1 clinical trials. Leriglitazone completed a<strong> phase 2/3 study in X-ALD (ADVANCE)</strong> in the EU and US showing a significant reduction of cerebral lesion progression and a reduction of incidences of cerebral lesions and myelopathy symptoms. Additionally, a <strong>separate study in paediatric cALD (NEXUS)</strong> is currently ongoing in EU and after 24 weeks of treatement, all evaluable patients in NEXUS were clinically stable and radiologically demonstrated disease arrest or lesion growth stabilization. Finnaly, a <strong>phase 3 study in adult male patients with progressive cALD (CALYX)</strong> is currently recruiting in the US. The marketing authorization application (MAA) for adult male X-ALD patients is currently under review by the EMA.</p> <p style="text-align: justify;">Leriglitazone offers a strong potential for indication expansion into other CNS diseases. In this regard, a proof of concept study in Friedreich's Ataxia (FRDA) showed clinical benefit in this population.</p></div> <div class="m-button"><a class="m-boton sta-hoverOFF" href="/our-science-overview/" target="_self"><i></i><i></i><i></i><i></i>Read more</a></div> </div> </div> </div> </div> </section></li> </ul> <ul id="panel_banner0_3" class="panel_banner"> <li data-index="0" id="panel_banner_item13_3" class="item col-0 clearfix"><section class="mdl-banner"> <article class="deferbg" data-mobile="/content/imgsxml/panel_banner/mob-group-29773.png" data-tablet="/content/imgsxml/panel_banner/tab-group-29773.png" data-desktop="/content/imgsxml/panel_banner/group-29773.png"> <div class="m-content"> <div class="m-image deferbg" data-mobile="/content/imgsxml/panel_banner/mob-group-29773.png" data-tablet="/content/imgsxml/panel_banner/tab-group-29773.png" data-desktop="/content/imgsxml/panel_banner/group-29773.png"></div> <div class="m-texto"> <div class="m-pre"><div>Our programs</div></div> <div class="m-title"><div> <div>Delivering innovative treatments</div> </div></div> <div class="m-text"><div style="text-align: justify;">Our wholly-owned lead asset, leriglitazone, is currently in clinical development for the treatment of a range of orphan CNS disorders with high unmet medical need.</div></div> <div class="m-button"><a class="m-boton sta-hoverOFF" href="/our-pipeline-overview/" target="_self"><i></i><i></i><i></i><i></i>Read More</a></div> </div> </div> </article> </section></li> </ul> <ul id="panel_news0_4" class="panel_news"> <li data-index="0" id="panel_news_item14_4" class="item col-0 clearfix"><section class="mdl-news"> <div class="m-content"> <div class="m-header"> <div class="m-pleft"> <div class="m-titular">News</div> <a class="m-boton2 sta-hoverOFF" href="/news/" target="_self"><i></i><i></i><i></i><i></i>See all</a> </div> <div class="m-arrows"> <div class="m-left m-boton sta-hoverOFF" aria-hidden="true"><i></i><i></i><i></i><i></i><span class="fa fa-angle-left"></span></div> <div class="m-right m-boton sta-hoverOFF" aria-hidden="true"><i></i><i></i><i></i><i></i><span class="fa fa-angle-right"></span></div> </div> </div> <div class="m-news"> <a class="m-new" href="/media/leriglitazone_halts_disease_progression_in_adult_patients_with_early_cerebral_adrenoleukodystrophy_in_compassionate-use_study_published_in_brain/"> <div class="m-newtitle">Leriglitazone halts disease progression in adult patients with early cerebral adrenoleukodystrophy in compassionate-use study published in Brain</div> <footer> <span>June 11th, 2024</span> <span></span> </footer> </a> <a class="m-new" href="/media/update_on_regulatory_review_of_nezglyal_in_the_eu/"> <div class="m-newtitle">Update on Regulatory Review of NEZGLYAL® (leriglitazone) in the EU</div> <footer> <span>May 31st, 2024</span> <span></span> </footer> </a> <a class="m-new" href="/media/rare_disease_day_2024_special_film_launched/"> <div class="m-newtitle">Rare Disease Day 2024 - Call for greater awareness of X-linked adrenoleukodystrophy and cerebral adrenoleukodystrophy – special film launched</div> <footer> <span>February 29th, 2024</span> <span></span> </footer> </a> <a class="m-new" href="/media/update_on_regulatory_review_of_leriglitazone_in_the_eu/"> <div class="m-newtitle">Update on Regulatory Review of leriglitazone in the EU</div> <footer> <span>January 26th, 2024</span> <span></span> </footer> </a> <a class="m-new" href="/media/minoryx_announces_enrollment_of_first_patients_with_cerebral_adrenoleukodystrophy_in_us_phase_3_clinical_trial_calyx/"> <div class="m-newtitle">Minoryx announces enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in US Phase 3 clinical trial, CALYX</div> <footer> <span>November 16th, 2023</span> <span></span> </footer> </a> <a class="m-new" href="/media/minoryx-gains-fda-approval-to-initiate-a-phase-3-clinical-trial-in-patients-with-cerebral-adrenoleukodystrophy/"> <div class="m-newtitle">Minoryx gains FDA approval to initiate a Phase 3 clinical trial in patients with cerebral Adrenoleukodystrophy</div> <footer> <span>May 31st, 2023</span> <span></span> </footer> </a> <a class="m-new" href="/media/minoryx-presents-positive-interim-results-from-nexus/"> <div class="m-newtitle">Minoryx presents positive interim results from NEXUS registration study for leriglitazone targeting pediatric ALD patients with cerebral adrenoleukodystrophy (cALD)</div> <footer> <span>April 25th, 2023</span> <span></span> </footer> </a> <a class="m-new" href="/media/the-lancet-neurology-publishes-results-from-minoryx-therapeutics-phase2-3-advance-clinical-trial-of-leriglitazone-in-x-linked-adrenoleukodystrophy/"> <div class="m-newtitle">The Lancet Neurology publishes results from Minoryx Therapeutics Phase 2/3 ADVANCE clinical trial of leriglitazone in X-linked Adrenoleukodystrophy</div> <footer> <span>January 20th, 2023</span> <span></span> </footer> </a> <a class="m-new" href="/media/leriglitazone’s-clinical-proof-of-concept-data-in-friedreich’s-ataxia-published-in-neurology-genetics/"> <div class="m-newtitle">Leriglitazone’s clinical proof of concept data in Friedreich’s Ataxia published in Neurology Genetics</div> <footer> <span>November 29th, 2022</span> <span></span> </footer> </a> <a class="m-new" href="/media/minoryx-and-neuraxpharm-announce-a-strategic-alliance-to-provide-a-new-therapy-for-rare-cns-disease-patients-in-europe/"> <div class="m-newtitle">Minoryx and Neuraxpharm announce a strategic alliance to provide a new therapy for rare CNS disease patients in Europe</div> <footer> <span>November 10th, 2022</span> <span></span> </footer> </a> </div> </div> </section></li> </ul> <ul id="panel_footer0_5" class="panel_footer"> <li><section class="mdl-footer"> <div class="m-content"> <div class="m-inter"> <div class="m-offices"> <a href="/contact/" class="m-boton2 sta-hoverOFF"><i></i><i></i><i></i><i></i>Contact</a> <article itemscope itemtype="http://schema.org/LocalBusiness"> <header itemprop="name">Headquarters</header> <span itemprop="image" class="hide">https://www.minoryx.com/content/imgs/mail/logo.png</span> <address itemprop="address" itemscope itemtype="http://schema.org/PostalAddress"> <span itemprop="streetAddress">Av. 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