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 and oncology that can bring value to patients.
Our scientists are focused on developing new molecules that leverage well-validated biological pathways, utilizing our expertise in advanced medicinal chemistry and protein engineering, coupled with a disciplined, integrated research approach.
- Preclinical
- Phase 1
- Phase 2
- Phase 3
- FDA-Approved
-
Neuroscience
-
LYBALVI™ (olanzapine and samidorphan) - Schizophrenia/Bipolar I Disorder
-
ALKS 1140 - Neurology (Orphan)
-
Orexin 2 Receptor Agonist - Narcolepsy
-
HDAC Inhibitors - Neurology/Neuropsychiatry (Non-Orphan)
-
HDAC Inhibitors - Frontotemporal Dementia
-
-
Oncology
-
Nemvaleukin alfa*
-
Tumor-Targeted Split IL-12
-
HDAC Inhibitors
-
IL-18
-
Scientific Platforms
As we look forward, we are taking a “bedside to bench” approach to R&D – reversing the typical thought process and beginning with real-world, unmet patient needs that inform our work as we seek to develop new treatments in the areas of neuroscience and oncology. Our drug development efforts are focused on two scientific research platforms with broad potential.
Synaptic Dysfunction
Our synaptic dysfunction platform is designed to improve the structure, function and environment of synapses. Improvement of synaptic integrity and function has the potential to slow progression, and preserve cognitive and functional abilities, in multiple neurological and psychiatric diseases.
Immune Modulation in Oncology
Our immuno-oncology platform is designed to harness the power of the immune system to fight cancer. We are developing novel cytokine-based therapies designed to increase visibility of tumor cells to the immune system, increase the tumor-killing potential of CD8+ T and Natural Killer cells, and remove suppressive signals in the tumor microenvironment. Nemvaleukin alfa, our most advanced investigational immunotherapy candidate, was developed using this platform.
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.
Protein Engineering
We are harnessing our established protein engineering platforms to develop novel cytokines with the potential to fight cancer.
Molecular Design
We have built a sophisticated molecular design toolbox to support our small molecule and biologics 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 40 clinical trials.
Alkermes Pathways Research Awards®
Alkermes Pathways Research Awards® is a competitive grant program for early-career investigators 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 the areas of schizophrenia, bipolar disorder, opioid use disorder and alcohol use disorder.
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 clinical trials using Alkermes’ marketed or investigational medicines, please consult the National Institutes of Health website, www.clinicaltrials.gov, which contains a searchable database.