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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Sodium oxybate extended-release oral suspension
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Idiopathic Hypersomnia
Phase 3
Overview
A once-nightly formulation of sodium oxybate for extended-release oral suspension is currently approved for people 7 years of age or older with narcolepsy in the U.S.
Clinical TrialsA once-nightly formulation of sodium oxybate for extended-release oral suspension is currently being evaluated for use in adults with idiopathic hypersomnia in a phase 3 study, REVITALYZ. For more information about this study, please visit clinicaltrials.gov/study/NCT06525077.
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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, ENLIGHTEN-Youth. For more information about this study, please visit enlightenyouthstudy.com (U.S. audiences only) or clinicaltrials.gov/study/NCT05303064.
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Alixorexton
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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
OverviewAlixorexton (formerly ALKS 2680) is an investigational, oral orexin 2 receptor agonist in development for the treatment of narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.
Clinical TrialsVibrance-1 and Vibrance-2, phase 2 studies evaluating alixorexton in adults with narcolepsy type 1 and narcolepsy type 2, respectively, are complete and phase 3 studies are expected to initiate in Q1 2026. Vibrance-3, a phase 2 study in adults with idiopathic hypersomnia is ongoing. 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 alixorexton for up to two years.
For more information about enrolling studies, please visit vibrancestudies.com (for U.S. audiences only) or the respective clinicaltrials.gov listings:- Vibrance-3: clinicaltrials.gov/study/NCT06843590
- Open-label Extension: clinicaltrials.gov/study/NCT06767683
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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.