R&D Pipeline

Pipeline of Key Proprietary Product Candidates

Our R&D pipeline reflects Alkermes' commitment to advancing Great Science that has the potential to provide meaningful impact for patients. We have a pipeline of product candidates in development for psychiatric and neurological 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.

Discovery
Preclinical
Phase 1
Phase 2
Phase 3

Sodium oxybate extended-release oral suspension
- 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 Trials
A 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.
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, ENLIGHTEN-Youth. For more information about this study, please visit enlightenyouthstudy.com (U.S. audiences only) or clinicaltrials.gov/study/NCT05303064.
Alixorexton
- Narcolepsy Type 1
  
  Phase 2
- Narcolepsy Type 2
  
  Phase 2
- Idiopathic Hypersomnia
  
  Phase 2
Overview
Alixorexton (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 Trials
Vibrance-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
ALKS 4510
- Fatigue - Neurodegenerative Disorders*
  
  Phase 1
Overview
ALKS 4510 is an investigational orexin 2 receptor agonist in developement for the treatment of fatigue associated with multiple sclerosis and Parkinson's disease. It is currently being evaluated in a phase 1 study in healthy volunteers.
ALKS 7290
- Attention-Deficit Hyperactivity Disorder
  
  Phase 1
Overview
ALKS 7290 is an investigational orexin 2 receptor agonist in development for the treatment of attention-deficit hyperactivity disorder (ADHD). It is currently being evaluated in a phase 1 study in healthy volunteers.
Valiloxybate
- Narcolepsy and Idiopathic Hypersomnia
  
  Phase 1
Overview
Valiloxybate is an investigational GABA_B receptor agonist in development for the treatment of patients with narcolepsy and idiopathic hypersomnia. It is currently being evaluated in a phase 1 pharmacokinetic study in healthy volunteers.

*In patients with fatigue associated with multiple sclerosis and Parkinson's disease
Last updated: February 2026