NDAORALTABLET
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
7/8 — Comprehensive
LYBALVI (olanzapine and samidorphan l-malate) by Alkermes is unclear; however, its efficacy in the treatment of schizophrenia or bipolar i disorder could be mediated through a combination of dopamine and serotonin type 2 (5ht 2 ) antagonism. Approved for schizophrenia. First approved in 2021.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYBALVI is an oral tablet combining olanzapine and samidorphan l-malate, approved by the FDA on May 28, 2021, for the treatment of schizophrenia. The combination leverages olanzapine's dopamine and serotonin 5-HT2 antagonism for antipsychotic efficacy, while samidorphan's opioid receptor antagonism is designed to mitigate weight gain—a major limitation of olanzapine monotherapy. This fixed-dose combination represents an innovation in atypical antipsychotic therapy, positioning LYBALVI as a differentiated option for patients at high risk of metabolic complications.
$0.1BPart D
15.5 years to LOEMechanism of Action
unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.
Pharmacologic Class:
Atypical Antipsychotic
Indications (1)
Clinical Trials (3)
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
Started Sep 2022
12 enrolled
Focus of Study is on Healthy Lactating Women
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
Started Jun 2015
10 enrolled
Healthy
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
Started Aug 2014
59 enrolled
Healthy Volunteers
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.