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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.

Click to view our interactive pipeline

  • Discovery
  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Olanzapine and samidorphan

    • Schizophrenia and Bipolar I Disorder (Pediatric)

      Phase 3

    Overview

    Olanzapine and samidorphan is a once-daily, oral atypical antipsychotic drug approved for adults in the U.S.

    Clinical Trials

    Olanzapine 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.

  • ALKS 2680

    • Narcolepsy Type 1

      Phase 2

    • Narcolepsy Type 2

      Phase 2

    • Idiopathic Hypersomnia

      Phase 1

    Overview

    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.

    Clinical Trials

    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.

    For more information about these studies, please visit vibrancestudies.com (for U.S. audiences only) or the respective clinicaltrials.gov listings:

  • Orexin Agonists

    • Neuroscience Indications

      Preclinical

    • Neuroscience Indications

      Preclinical

    Overview

    Additional orexin 2 receptor agonists are in preclinical research for the treatment of other neurological and psychiatric disorders.

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. 






Last updated: December 2024

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.



Research & Medical Grants

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 40 clinical trials.


Learn more

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.



Discover Pathways

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.


Program details

Woman in lab coat with blue gloves, glasses and a mask speaking to colleague at Alkermes

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.

Laura Tan,
Research Scientist

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.


View Alkermes' ongoing clinical studies

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Early Access

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.


View our Early Access Policy