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Label indication RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. FDA label
Risperidone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Risperidone | EXPERIMENTAL | Risperidone Tablets 1 mg of Dr Reddys Laboratories Limited |
| Risperdal | ACTIVE_COMPARATOR | Risperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P |
| Risperdal® | ACTIVE_COMPARATOR | Risperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P |
| Name | Type | Description |
|---|---|---|
| Risperidone | DRUG | Risperidone Tablets 1 mg |
Inclusion Criteria: 1. Males and females, 18 - 55 years of age. 2. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and du...
Risperidone is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is an antagonist that acts on the HTR2A, HTR2C, and DRD2 targets. The specific indications being studied are undisclosed. It is currently in Phase 1 clinical development.
Risperidone targets HTR2A, HTR2C, and DRD2. It acts as an antagonist at these receptors. This mechanism of action is the basis for its clinical development as a small molecule therapeutic.
Risperidone is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical trials for this asset.
Risperidone is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes two completed trials.
Risperidone has been studied in two completed Phase 1 trials. NCT01064271 was a bioequivalence study of 1 mg tablets under fed conditions with 26 participants. NCT01064232 was a bioequivalence study of 1 mg tablets under fasting conditions with 30 participants.
Yes, the risperidone Phase 1 trials are randomized and active-controlled. They are not double-blind. Both trials enrolled healthy volunteers aged 18 years and older, with a total enrollment of 56 participants across the two completed studies.