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Placebo Asenapine
Asenapine is an atypical antipsychotic that blocks dopamine and serotonin receptors in the brain to reduce psychotic symptoms and mood disturbances.
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 | Placebo Asenapine |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Atypical antipsychotic |
| Target | D2 dopamine receptor, 5-HT2A serotonin receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Asenapine acts as an antagonist at multiple dopamine receptors (D2, D3) and serotonin receptors (5-HT2A, 5-HT7), with particular affinity for D2 and 5-HT2A. This dual antagonism is characteristic of atypical antipsychotics and helps reduce both positive symptoms (hallucinations, delusions) and negative symptoms (withdrawal, apathy) of psychotic disorders while potentially having a lower risk of extrapyramidal side effects compared to typical antipsychotics.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute manic or mixed episodes)
Common side effects
- Akathisia
- Somnolence
- Parkinsonism
- Oral hypoesthesia/paresthesia
- Weight gain
- Headache
Key clinical trials
- 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 With Placebo and Olanzapine (41021)(P05933) (PHASE3)
- Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) (PHASE3)
- Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947) (PHASE3)
- 6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124) (PHASE3)
- Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107) (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:
- Placebo Asenapine CI brief — competitive landscape report
- Placebo Asenapine updates RSS · CI watch RSS
- Organon and Co portfolio CI