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Research & Development, Approach & Pipeline | Alkermes
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src="/getmedia/9da2a00c-4589-4693-82cf-b3eae4f444db/woman-in-lab-smiling-m.jpg" class="d-block d-md-none fr-fil fr-dib" alt="woman in lab"><img src="/getmedia/b8c5fc1b-63b8-4ab9-84d2-34861c36c8b2/Asset-8@4x_2.png" style="transform: scaleX(-1) rotate(270deg);" class="triangle fr-fic fr-fir fr-dii" data-id="d0d26a4e-a77e-47d1-8c58-6719d92b0f61" alt="woman in lab"><div><h1 class="d-none d-md-block">Research & Development</h1><h1 class="d-md-none mb-0">Research &<br>Development</h1><h2>Science With<br>a Purpose</h2></div></div> </div> </div> </div> <div class="row one-column-section"> <div class="col-md-12"> <div class="fr-view"> <div class="small-tile-light-green"><div><h3 style="text-align: center;"><span style="color: rgb(47, 119, 129);">Our Approach</span></h3><p><br></p><p>Our R&D approach is grounded in a thoughtful focus on real-world challenges faced by people living with complex and serious diseases. Through this lens, we seek to develop innovative medicines in neuroscience that can make a difference for patients. </p><p>Our scientists are focused on developing new molecules that leverage well-validated biological pathways, utilizing our expertise in advanced medicinal chemistry. </p><p>We start with a “bedside to bench” approach – reversing the typical thought process and beginning with real-world, unmet patient needs that inform our work as we seek to develop potential new treatments for psychiatric and neurological disorders.</p></div></div> </div> </div> </div> </div> <div class="pipeline-home r-and-d"> <div class="col-xs-12 col-md-4" style="display: flex; flex-direction: column;margin-right:5vw;color: #1d7983;"> <div class="fr-view"> <div><h3>R&D Pipeline </h3><p><br></p><h5>We apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. We are currently focused on developing these investigational candidates.</h5><p style="margin-top:5vw;"><a class="green-rounded-border" href="/pipeline">Click to view our interactive pipeline</a></p></div> </div> <div> </div> </div> <div class="pipeline"> <div class="pb-3"> <div class="head d-none d-md-block"> <ul> <li>Discovery</li> <li>Preclinical</li> <li>Phase 1</li> <li>Phase 2</li> <li>Phase 3</li> </ul> </div> <div class="body"> <ul> <li class="molecule py-2"> <p class="m-0 pb-0">Olanzapine and samidorphan</p> <div class="toggle-overlay"></div> <ul> <li class="product"> <p class="mt-2">Schizophrenia and Bipolar I Disorder (Pediatric)</p> <div class="my-1 phase-100"> <div style="width:100%"></div> </div> <p class="d-md-none pb-3"> <span>Phase 3</span> </p> </li> </ul> <div class="extra"> <div class="d-flex flex-column"><strong>Overview</strong> <p>Olanzapine and samidorphan is a once-daily, oral atypical antipsychotic drug approved for adults in the U.S.</p></div> <div class="d-flex flex-column"><strong>Clinical Trials</strong> <p>Olanzapine and samidorphan is currently being evaluated for pediatric use in a phase 3 study. For more information about this study, please visit <strong><a href="https://www.enlightenyouthstudy.com" target="_blank">enlightenyouthstudy.com</a></strong> (U.S. audiences only) or <a href="https://www.clinicaltrials.gov/study/NCT05303064" target="_blank"><strong>clinicaltrials.gov/study/NCT05303064</strong></a>.</p></div> <div class="d-flex m-0"> </div> </div> </li> <li class="molecule py-2"> <p class="m-0 pb-0">ALKS 2680</p> <div class="toggle-overlay"></div> <ul> <li class="product"> <p class="mt-2">Narcolepsy Type 1</p> <div class="my-1 phase-80"> <div style="width:80%"></div> </div> <p class="d-md-none pb-3"> <span>Phase 2</span> </p> </li> <li class="product"> <p class="mt-2">Narcolepsy Type 2</p> <div class="my-1 phase-80"> <div style="width:80%"></div> </div> <p class="d-md-none pb-3"> <span>Phase 2</span> </p> </li> <li class="product"> <p class="mt-2">Idiopathic Hypersomnia</p> <div class="my-1 phase-60"> <div style="width:60%"></div> </div> <p class="d-md-none pb-3"> <span>Phase 1</span> </p> </li> </ul> <div class="extra"> <div class="d-flex flex-column"><strong>Overview</strong> <p>ALKS 2680 is an investigational, oral orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.</p> </div> <div class="d-flex flex-column"><strong>Clinical Trials</strong> <p>ALKS 2680 is currently being evaluated in Vibrance-1, a phase 2 study in adults with narcolepsy type 1, and Vibrance-2, a phase 2 study in adults with narcolepsy type 2.<br /> <br /> For more information about these studies, please visit <strong><a href="https://vibrancestudies.com/?utm_source=alkermes&utm_medium=pipeline&utm_campaign=pipeline-2024" target="_blank">vibrancestudies.com</a></strong> (for U.S. audiences only) or the respective clinicaltrials.gov listings:</p> <ul> <li><strong>Vibrance-1: <a href="https://www.clinicaltrials.gov/study/NCT06358950" target="_blank">clinicaltrials.gov/study/NCT06358950</a></strong></li> <li><strong>Vibrance-2: <a href="https://www.clinicaltrials.gov/study/NCT06555783" target="_blank">clinicaltrials.gov/study/NCT06555783</a></strong></li> </ul> </div> <div class="d-flex m-0"> </div> </div> </li> <li class="molecule py-2"> <p class="m-0 pb-0">ALKS 4510</p> <div class="toggle-overlay"></div> <ul> <li class="product"> <p class="mt-2">Neuroscience Indications</p> <div class="my-1 phase-39"> <div style="width:39%"></div> </div> <p class="d-md-none pb-3"> <span>Preclinical</span> </p> </li> </ul> <div class="extra"> <div class="d-flex flex-column"><strong>Overview</strong> <p>ALKS 4510 is an investigational orexin 2 receptor agonist being evaluated preclinically for the treatment of central nervous system disorders.</p> </div> <div class="d-flex m-0"> </div> </div> </li> <li class="molecule py-2"> <p class="m-0 pb-0">ALKS 7290</p> <div class="toggle-overlay"></div> <ul> <li class="product"> <p class="mt-2">Neuroscience Indications</p> <div class="my-1 phase-39"> <div style="width:39%"></div> </div> <p class="d-md-none pb-3"> <span>Preclinical</span> </p> </li> </ul> <div class="extra"> <div class="d-flex flex-column"><strong>Overview</strong> <p>ALKS 7290 is an investigational orexin 2 receptor agonist being evaluated preclinically for the treatment of central nervous system disorders.</p> </div> <div class="d-flex m-0"> </div> </div> </li> </ul> </div> <div class="foot"> <div class="fr-view"> <div style="display:flex;flex-direction:row;justify-content:space-between;flex-wrap:wrap;"><div style="width:100%;">These programs are investigating treatments or indications that have not received approval from a health authority. The information presented is not intended to convey conclusions of safety or efficacy. There is no guarantee that the outcome of these studies will result in approval by a health authority. </div><p><br></p><p><br></p><p><br></p><p><br></p><div style="width:100%;"><br></div><div style="width:100%;"><em>L</em><em>ast updated: January 2025</em></div></div> </div> <div> </div> </div> </div> </div> </div> <div> <div class="row one-column-section two-triangle-green v3"> <div class="col-md-12"> <div class="fr-view"> <div style="background-image:none;background-color:#137680;flex-wrap:wrap;"><div style="background-color: transparent;width: 80%;color: #ffffff;text-align:center;height:auto;"><a name="corporate-giving"></a><h3>Technologies & Capabilities</h3><h5>We leverage our proprietary technologies and molecular design capabilities to design innovative medicines with distinct therapeutic properties.</h5></div><div><h4>Long-Acting Technologies </h4><p><br></p><p>Our suite of long-acting injectable technologies enables the gradual release of small molecules as well as complex macromolecules into the body at a controlled rate over a specific period of time. These include Medisorb<sup>®</sup>, LinkeRx<sup>®</sup> and NanoCrystal<sup>®</sup>.</p></div><div><h4>Oral Controlled-Release Technologies </h4><p><br></p><p>Our broad array of customized, solid-oral dosage technologies, including oral delayed-release, extended-release, immediate-release, pulsatile-release and chrono-timed delivery enable us to customize specific drug-release profiles and dosage forms.</p></div><div><h4>Molecular Design </h4><p><br></p><p>We have built a sophisticated molecular design toolbox to support our small molecule projects. This includes advanced molecular dynamics simulations, quantum chemical calculations, artificial intelligence and proprietary machine learning models.</p></div><p style="text-align:center;"><br><br></p></div> </div> <div class="fr-view"> <div style="flex-wrap:wrap;padding-top: 1vw;"><div style="width: 100%;background:none;text-align:center; padding: 2.5vw 0;"><a name="research-and-medical-grants"></a><h3 style="color:white; text-align:left;">Research & Medical Grants</h3></div><div style="width: 28.5vw;"><h4 style=" height: 7vw;">Investigator Sponsored Studies</h4><p>We seek to support investigator research designed and conducted by independent clinicians and scientists. Since the onset of our Investigator Sponsored Studies (ISS) program in 2008, we have supported more than 50 clinical trials.<br><br></p><p><br></p><p style="text-align:right;"><a class="green-rounded-border" href="/research-and-development/investigator-sponsored-studies">Learn more</a></p></div><div style="width: 28.5vw;"><h4 style=" height: 7vw;">Alkermes Pathways Research Awards<sup>®</sup></h4><p>Alkermes Pathways Research Awards<sup>®</sup> is a competitive grant program for the next generation of researchers working on the front lines to advance understanding and awareness of disease states in the field of neuroscience.<br><br><br><br></p><p style="text-align:right;"><a class="green-rounded-border" href="/research-and-development/pathways">Discover Pathways</a></p></div><div style="width: 28.5vw;"><h4 style=" height: 7vw;">Medical Education Grants</h4><p>We contribute to independent education by supporting medical education grants. Our focus areas include accredited educational activities with pragmatic approaches to improve patient care and public health in our therapeutic areas of focus.</p><p><br></p><p style="text-align:right;"><a class="green-rounded-border" href="/research-and-development/medical-education-grants">Program details</a></p></div></div> </div> </div> </div> <div class="row one-column-section"> <div class="col-md-12"> <div class="fr-view"> <div class="home-quote"><img src="/getmedia/15c38dba-0cdc-44b9-807a-ec30942dac48/Laura-Tan-Hero-cr2.jpg" style="width:100%;" class="fr-fic fr-dib" data-name="Laura-Tan-Hero-cr2" data-id="15c38dba-0cdc-44b9-807a-ec30942dac48" alt="Woman in lab coat with blue gloves, glasses and a mask speaking to colleague at Alkermes"><div><div class="blockquote col-6 col-md-5"><h4>As a researcher, one of the most exciting things I do is coming up with ideas that will affect patients in the long-term. My job is to figure out how we can make the biggest impact.</h4></div><div class="col-6 col-md-5" style="display:flex; justify-content:flex-end;"><p class="col-md-6 col-xs-8" style="text-align:left;">Laura Tan,<br>Research Scientist</p></div></div></div> </div> </div> </div> <div class="row one-column-section"> <div class="col-md-12"> <div class="fr-view"> <div class="centri green" style="height: auto;"><div style="padding:3vw 9vw;"><a name="clinical-trials"></a><h3>Clinical Trials</h3><h5>Alkermes is committed to researching and developing innovative medicines that can help address unmet needs of patients and their families. Clinical trials are a critical part of this process, during which we seek to determine the safety and efficacy of an investigational medicine or build further understanding of a marketed medicine.<br><br></h5><h5>For information about ongoing clinical trials using Alkermes’ marketed or investigational medicines, please consult the National Institutes of Health website, www.clinicaltrials.gov, which contains a searchable database.</h5><p><br></p><p><a class="white-rounded-border" href="https://clinicaltrials.gov/search?lead=Alkermes,%20Inc.&aggFilters=status:not%20rec" rel="noopener noreferrer" target="_blank">View Alkermes' ongoing clinical studies</a></p></div></div> </div> </div> </div> <div class="row one-column-section"> <div class="col-md-12"> <div class="fr-view"> <div style="position: relative;background-color:#edf9f7;display:flex;flex-direction:row;justify-content: space-between;padding: 6vw 15vw 9vw 15vw;color:#137681;"><div><img src="/getmedia/b8c5fc1b-63b8-4ab9-84d2-34861c36c8b2/Asset-8@4x_2.png" data-strid="d5de477d-d1d3-462c-8415-b3cc9a083671" style="width: 20vw;position: absolute;bottom:0;left:0;transform: rotate(180deg);margin:0;" class="fr-fic fr-dib" data-name="Asset-8@4x_1" data-id="d0d26a4e-a77e-47d1-8c58-6719d92b0f61" alt="Lower left triangle graphic."> <a name="early-access"></a><h3>Early Access</h3><h5 style="font-family:'Nunito Sans';"><span style="color: rgb(51, 63, 72);">Alkermes’ goal is to develop safe and effective medicines by conducting rigorous clinical trials and obtaining marketing approval from regulatory authorities, including the U.S. Food and Drug Administration (FDA). Participation in one of our clinical trials is the optimal way for patients to gain access to our investigational medicines prior to regulatory approval. However, we understand that some patients may not be able to participate in a clinical trial. If early data from clinical trials suggest that an investigational treatment might offer benefits for patients facing serious or life-threatening conditions, Alkermes has a policy under which patients may be eligible to receive access to an investigational medicine outside the context of a clinical trial. If you are interested in early access to an Alkermes investigational therapy, please read the Alkermes Early Access Policy for additional details and eligibility considerations.</span></h5><p><br></p><p style="text-align: right;"><a class="green-rounded-border" href="/getmedia/508bf0e5-5be6-480e-a902-7bfa1cb950f0/early-access-policy.pdf" rel="noopener noreferrer" target="_blank">View our Early Access Policy</a></p></div></div> </div> </div> </div> </div> </div> </div> <div class="footer-wrapper"> <footer> <div class="footer-container"> <div class="row"> <div class="col-xs-3 logo"> <img src="/images/logo.svg" alt="logo" /> </div> <div class="col-xs-9 col-md-6"> <ul> <li> <a href="/contact-us">Contact Us</a> </li> <li> <a href="/terms-of-use">Terms of Use</a> </li> <li> <a href="/privacy">Privacy Policy</a> </li> <li> <a href="/sitemap">Sitemap</a> </li> </ul> </div> <div class="col-xs-3"> <div class="d-none d-md-block col-md-3"></div> <div class="col-xs-3"> <a href="https://www.youtube.com/channel/UC1CXRHrg3JzXO962jQctF7w" target="_blank" class="followus-link"> <img src="/images/youtube_logo.svg" alt="logo" /> </a> </div> <div class="col-xs-3"> <a href="https://twitter.com/alkermes" target="_blank" class="followus-link"> <img src="/images/tw-x_logo.svg" alt="logo" /> </a> </div> <div class="col-xs-3"> <a href="https://www.linkedin.com/company/alkermes" target="_blank" class="followus-link"> <img src="/images/li_logo.svg" alt="logo" /> </a> </div> </div> <div class="col-md-12 col-xs-9"> <div class="copyright"> © 2025 Alkermes. 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