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SAPHRIS
SAPHRIS (asenapine) is an atypical antipsychotic that blocks dopamine and serotonin receptors in the brain to reduce psychotic symptoms and mood disturbances.
SAPHRIS (asenapine) is an atypical antipsychotic that blocks dopamine and serotonin receptors in the brain to reduce psychotic symptoms and mood disturbances. Used for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes).
At a glance
| Generic name | SAPHRIS |
|---|---|
| Sponsor | Sun Pharmaceutical Industries Limited |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Serotonin 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Asenapine antagonizes dopamine D2 receptors and serotonin 5-HT2A receptors, among others, which helps alleviate positive symptoms of psychosis (hallucinations, delusions) and mood symptoms in bipolar disorder. The dual dopamine-serotonin antagonism is characteristic of atypical antipsychotics and is associated with a lower risk of extrapyramidal side effects compared to first-generation antipsychotics.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute manic or mixed episodes)
Common side effects
- Akathisia
- Somnolence
- Parkinsonism
- Dizziness
- Weight gain
- Oral hypoesthesia
Key clinical trials
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
- An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED) (PHASE2)
- 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED) (PHASE3)
- Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED) (PHASE3)
- 3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009) (PHASE3)
- 3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008) (PHASE3)
- Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817) (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:
- SAPHRIS CI brief — competitive landscape report
- SAPHRIS updates RSS · CI watch RSS
- Sun Pharmaceutical Industries Limited portfolio CI