Last reviewed 2026-04-20 · How we verify

ALKS 3831

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Weight increased
• Somnolence
• Headache
• Weight decreased
• Blood creatine phosphokinase increased
• Extra dose administered
• Anxiety
• Weight Increased
• Nausea
• Increased appetite
• Nasopharyngitis
• Insomnia

Key clinical trials

• Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (PHASE3)
• Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (PHASE3)
• Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (PHASE3)
• Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder (PHASE1)
• Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan (PHASE1)
• Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder (PHASE3)
• A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder (PHASE2)
• A Study of ALKS 3831 in Adults With Schizophrenia (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• ALKS 3831 CI brief — competitive landscape report
• ALKS 3831 updates RSS · CI watch RSS
• Alkermes, Inc. portfolio CI