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LYBALVI
LYBALVI is a combination of lurasidone (an atypical antipsychotic) and samidorphan (an opioid antagonist) that blocks dopamine and serotonin receptors while antagonizing opioid receptors to reduce antipsychotic-induced weight gain.
LYBALVI is a combination of lurasidone (an atypical antipsychotic) and samidorphan (an opioid antagonist) that blocks dopamine and serotonin receptors while antagonizing opioid receptors to reduce antipsychotic-induced weight gain. Used for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes).
At a glance
| Generic name | LYBALVI |
|---|---|
| Also known as | Olanzapine/samidorphan (OLZ/SAM), ALKS 3831 |
| Sponsor | Alkermes, Inc. |
| Drug class | Atypical antipsychotic with opioid antagonist |
| Target | D2 dopamine receptor, 5-HT7 serotonin receptor, mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Lurasidone acts as a D2 dopamine receptor and 5-HT7 serotonin receptor antagonist to treat psychotic symptoms, while samidorphan blocks mu-opioid receptors to counteract the weight gain and metabolic effects commonly associated with antipsychotic therapy. This combination approach addresses both the psychiatric symptoms and a major side effect of antipsychotic monotherapy.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute manic or mixed episodes)
Common side effects
- Akathisia
- Somnolence
- Parkinsonism
- Nausea
- Headache
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)
- National Pregnancy Registry for Psychiatric Medications
- 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:
- LYBALVI CI brief — competitive landscape report
- LYBALVI updates RSS · CI watch RSS
- Alkermes, Inc. portfolio CI