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SAMIDORPHAN L-MALATE
SAMIDORPHAN L-MALATE is a Atypical Antipsychotic [EPC] drug. It is currently FDA-approved (first approved 2021) for Schizophrenia, Bipolar I Disorder - Acute Manic or Mixed Episodes, Bipolar I Disorder - Maintenance Monotherapy.
Olanzapine's efficacy may be due to dopamine and serotonin type 2 antagonism, while samidorphan acts through opioid receptor antagonism.
SAMIDORPHAN L-MALATE is a small molecule that acts as a partial agonist at the kappa-type opioid receptor. It is classified as a kappa opioid receptor partial agonist.
At a glance
| Generic name | SAMIDORPHAN L-MALATE |
|---|---|
| Drug class | Atypical Antipsychotic [EPC] |
| Target | dopamine and serotonin type 2 (5HT2) receptors, opioid receptors |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Olanzapine's effectiveness in treating schizophrenia or bipolar I disorder might be due to its ability to block dopamine and serotonin type 2 receptors. Samidorphan's mechanism involves blocking opioid receptors.
Approved indications
- Schizophrenia
- Bipolar I Disorder - Acute Manic or Mixed Episodes
- Bipolar I Disorder - Maintenance Monotherapy
Boxed warnings
- WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 )
Common side effects
- weight increased
- somnolence
- dry mouth
- headache
- blood insulin increased
- sedation
- dizziness
- neutrophil count decreased
Drug interactions
- Strong CYP3A4 Inducers
- Strong CYP1A2 Inhibitors
- CYP1A2 Inducers
- Diazepam, Alcohol, and Other CNS Acting Drugs
- Anticholinergic Drugs
- Antihypertensive Agents
- Levodopa and Dopamine Agonists
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SAMIDORPHAN L-MALATE CI brief — competitive landscape report
- SAMIDORPHAN L-MALATE updates RSS · CI watch RSS
Frequently asked questions about SAMIDORPHAN L-MALATE
What is SAMIDORPHAN L-MALATE?
How does SAMIDORPHAN L-MALATE work?
What is SAMIDORPHAN L-MALATE used for?
What drug class is SAMIDORPHAN L-MALATE in?
When was SAMIDORPHAN L-MALATE approved?
What development phase is SAMIDORPHAN L-MALATE in?
What are the side effects of SAMIDORPHAN L-MALATE?
What does SAMIDORPHAN L-MALATE target?
Related
- Drug class: All Atypical Antipsychotic [EPC] drugs
- Target: All drugs targeting dopamine and serotonin type 2 (5HT2) receptors, opioid receptors
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar I Disorder - Acute Manic or Mixed Episodes
- Indication: Drugs for Bipolar I Disorder - Maintenance Monotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing