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Asenapine - Double Blind
Asenapine - Double Blind is a Atypical antipsychotic Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes). Also known as: Org 5222, SCH 900274, Saphris.
Asenapine is an atypical antipsychotic that blocks dopamine and serotonin receptors in the brain to reduce psychotic symptoms and mood disturbances.
Asenapine is a small molecule medication used to treat conditions such as bipolar disorder, bipolar I disorder, schizophrenia, and schizophrenia with disorganized symptoms. The exact mechanism of action of asenapine is currently unknown.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Asenapine - Double Blind |
|---|---|
| Also known as | Org 5222, SCH 900274, Saphris |
| Sponsor | Organon and Co |
| Drug class | Atypical antipsychotic |
| Target | D2 dopamine receptor, 5-HT2A serotonin receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
Asenapine acts as an antagonist at multiple neurotransmitter receptors, primarily D2 dopamine receptors and 5-HT2A serotonin receptors. This dual antagonism helps alleviate positive symptoms of psychosis (hallucinations, delusions) and mood symptoms associated with schizophrenia and bipolar disorder. The sublingual formulation allows for rapid absorption and potentially improved patient compliance.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute manic or mixed episodes)
Common side effects
- Akathisia
- Somnolence
- Parkinsonism
- Oral hypoesthesia/paresthesia
- Weight gain
- Dizziness
Key clinical trials
- 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)
- 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)
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:
- Asenapine - Double Blind CI brief — competitive landscape report
- Asenapine - Double Blind updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Asenapine - Double Blind
What is Asenapine - Double Blind?
How does Asenapine - Double Blind work?
What is Asenapine - Double Blind used for?
Who makes Asenapine - Double Blind?
Is Asenapine - Double Blind also known as anything else?
What drug class is Asenapine - Double Blind in?
What development phase is Asenapine - Double Blind in?
What are the side effects of Asenapine - Double Blind?
What does Asenapine - Double Blind target?
Related
- Drug class: All Atypical antipsychotic drugs
- Target: All drugs targeting D2 dopamine receptor, 5-HT2A serotonin receptor
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Psychiatry/Neurology
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar I disorder (acute manic or mixed episodes)
- Also known as: Org 5222, SCH 900274, Saphris
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing