Research & Development
Research &
Development
Science With
a Purpose
Our Approach
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.
Our scientists are focused on developing new molecules that leverage well-validated biological pathways, utilizing our expertise in advanced medicinal chemistry.
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.
R&D Pipeline
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.
- Discovery
- Preclinical
- Phase 1
- Phase 2
- Phase 3
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Olanzapine and samidorphan
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Schizophrenia and Bipolar I Disorder (Pediatric)
Phase 3
OverviewOlanzapine and samidorphan is a once-daily, oral atypical antipsychotic drug approved for adults in the U.S.
Clinical TrialsOlanzapine and samidorphan is currently being evaluated for pediatric use in a phase 3 study. For more information about this study, please visit enlightenyouthstudy.com (U.S. audiences only) or clinicaltrials.gov/study/NCT05303064.
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ALKS 2680
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Narcolepsy Type 1
Phase 2
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Narcolepsy Type 2
Phase 2
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Idiopathic Hypersomnia
Phase 2
OverviewALKS 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.
Clinical TrialsALKS 2680 is currently being evaluated in Vibrance-1, a phase 2 study in adults with narcolepsy type 1, Vibrance-2, a phase 2 study in adults with narcolepsy type 2, and Vibrance-3, a phase 2 study in adults with idiopathic hypersomnia. Participants who complete one of the Vibrance studies have the option to continue in a long-term, open-label, safety study evaluating the safety of ALKS 2680 for up to two years.
For more information about these studies, please visit vibrancestudies.com (for U.S. audiences only) or the respective clinicaltrials.gov listings:- Vibrance-1: clinicaltrials.gov/study/NCT06358950
- Vibrance-2: clinicaltrials.gov/study/NCT06555783
- Vibrance-3: clinicaltrials.gov/study/NCT06843590
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ALKS 4510
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Neuroscience Indications
Phase 1
OverviewALKS 4510 is an investigational orexin 2 receptor agonist in developement for the treatment of central nervous system disorders. It is currently being evaluted in a phase 1 study in healthy volunteers.
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ALKS 7290
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Neuroscience Indications
Preclinical
OverviewALKS 7290 is an investigational orexin 2 receptor agonist being evaluated preclinically for the treatment of central nervous system disorders.
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Technologies & Capabilities
We leverage our proprietary technologies and molecular design capabilities to design innovative medicines with distinct therapeutic properties.
Long-Acting Technologies
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®, LinkeRx® and NanoCrystal®.
Oral Controlled-Release Technologies
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.
Molecular Design
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.
Investigator Sponsored Studies
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.
Alkermes Pathways Research Awards®
Alkermes Pathways Research Awards® 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.
Medical Education Grants
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.
Clinical Trials
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.
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.