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SM-13496 (lurasidone HCl)
SM-13496 (lurasidone HCl) is an atypical antipsychotic that acts as a serotonin 2A receptor antagonist and a dopamine receptor antagonist.
SM-13496 (lurasidone HCl) is an atypical antipsychotic that acts as a serotonin 2A receptor antagonist and a dopamine receptor antagonist. Used for Schizophrenia, Bipolar I disorder.
At a glance
| Generic name | SM-13496 (lurasidone HCl) |
|---|---|
| Sponsor | Sumitomo Pharma Co., Ltd. |
| Drug class | atypical antipsychotic |
| Target | serotonin 2A receptor, dopamine D2 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Lurasidone's mechanism of action involves blocking the action of serotonin and dopamine in the brain, which helps to reduce symptoms of psychosis and improve mood. This is achieved through its antagonism of the serotonin 2A receptor and the dopamine D2 receptor. By modulating these receptors, lurasidone helps to restore balance to the brain's neurotransmitter systems.
Approved indications
- Schizophrenia
- Bipolar I disorder
Common side effects
- Orthostatic hypotension
- Weight gain
- Somnolence
- Headache
- Nausea
Key clinical trials
- An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (PHASE4)
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- Sleep Quality, Cognitive Performance, and Computerized Cognitive Training
- High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia (PHASE4)
- Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (PHASE3)
- A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication (PHASE2)
- Lurasidone Non-Interventional Study in Schizophrenia Patients
- NRX-101 for Bipolar Depression With Subacute Suicidal Ideation (PHASE2, PHASE3)
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:
- SM-13496 (lurasidone HCl) CI brief — competitive landscape report
- SM-13496 (lurasidone HCl) updates RSS · CI watch RSS
- Sumitomo Pharma Co., Ltd. portfolio CI