NDAORALTABLET
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
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 12h ago · AI intelligence enriched 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYBALVI is an oral tablet combining olanzapine (dopamine/serotonin antagonist) with samidorphan (opioid receptor antagonist) for treating schizophrenia. The dual mechanism aims to maintain antipsychotic efficacy while mitigating weight gain and metabolic side effects common to olanzapine monotherapy. It represents an innovative approach to improving tolerability in atypical antipsychotic treatment.
$0.09BPart D
Peak15.3 years to LOEProduct is at peak commercial performance with 56,531 Part D claims in 2023, indicating active market presence and stable team investment.
Mechanism 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 (2)
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
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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.