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OLZ/SAM
OLZ/SAM is an oral, fixed-dose combination of olanzapine and samidorphan, a partial agonist at the μ-opioid receptor.
OLZ/SAM is an oral, fixed-dose combination of olanzapine and samidorphan, a partial agonist at the μ-opioid receptor. Used for Treatment of schizophrenia.
At a glance
| Generic name | OLZ/SAM |
|---|---|
| Also known as | ALKS 3831, ALKS 3831, LYBALVI |
| Sponsor | Alkermes, Inc. |
| Drug class | Atypical antipsychotic |
| Target | Serotonin 5-HT2A receptor, Dopamine D2 receptor, μ-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Olanzapine is an atypical antipsychotic that acts as a serotonin 5-HT2A receptor antagonist and a dopamine D2 receptor antagonist. Samidorphan is a partial agonist at the μ-opioid receptor, which helps to mitigate the weight gain associated with olanzapine.
Approved indications
- Treatment of schizophrenia
Common side effects
- Weight gain
- Dizziness
- Nausea
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)
- 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)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OLZ/SAM CI brief — competitive landscape report
- OLZ/SAM updates RSS · CI watch RSS
- Alkermes, Inc. portfolio CI