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Placebo of Risperidone ISM
This is a placebo control formulation used in clinical trials to compare against the active Risperidone ISM (intramuscular sustained-release) antipsychotic.
This is a placebo control formulation used in clinical trials to compare against the active Risperidone ISM (intramuscular sustained-release) antipsychotic. Used for Control arm in Phase 3 trials for schizophrenia or other psychotic disorders (specific indication depends on the active Risperidone ISM trial).
At a glance
| Generic name | Placebo of Risperidone ISM |
|---|---|
| Also known as | PLACEBO |
| Sponsor | Rovi Pharmaceuticals Laboratories |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
As a placebo, this formulation contains no active pharmaceutical ingredient and serves as a control arm in Phase 3 trials. Risperidone ISM itself is a dopamine D2 and serotonin 5-HT2A receptor antagonist delivered via long-acting intramuscular injection, but the placebo version is inert and used to establish efficacy and safety of the active drug through blinded comparison.
Approved indications
- Control arm in Phase 3 trials for schizophrenia or other psychotic disorders (specific indication depends on the active Risperidone ISM trial)
Common side effects
Key clinical trials
- Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension (PHASE3)
- Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia (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 of Risperidone ISM CI brief — competitive landscape report
- Placebo of Risperidone ISM updates RSS · CI watch RSS
- Rovi Pharmaceuticals Laboratories portfolio CI