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Label indication GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. FDA label
Also known as Ziprasidone Hydrochloride, Geodon
Ziprasidone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Ziprasidone HCL Capsules, 20 mg | EXPERIMENTAL | Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Laboratories Limited |
| Geodon Capsules, 20 mg | EXPERIMENTAL | Geodon Capsules, 20 mg of Pfizer Inc |
| Name | Type | Description |
|---|---|---|
| Ziprasidone Hydrochloride | DRUG | Ziprasidone HCL Capsules, 20 mg |
Inclusion Criteria: * Male or female, smoker or non-smoker, 18 years of age and older. * Capable of consent. * BMI between 19.0 and 30.0 kg/m2 inclusively. Exclusion Criteria: * Clinically significant illnesses within 4 weeks prior to the administration of the study medication. * Clinically signi...
Ziprasidone is a small molecule drug developed by Dr. Reddy's Laboratories Ltd (ticker RDY). It is an antagonist that targets HTR2A, DRD2, and HTR2C. The program is in Phase 1 development, and the specific indication being studied is undisclosed. It is also known as ziprasidone hydrochloride.
Ziprasidone targets HTR2A, DRD2, and HTR2C. It acts as an antagonist at these receptors. This receptor binding profile places it in the antipsychotic class of small molecule therapeutics. The specific disease indication being pursued by Dr. Reddy's Laboratories is undisclosed.
Ziprasidone is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is running the clinical development program for this small molecule asset. The program is currently in Phase 1, with two completed bioequivalence trials conducted in the United States.
Ziprasidone is in Phase 1 clinical development. It is investigational and has not been approved based on the data reviewed here. Two Phase 1 trials have been completed, with no active trials ongoing. Both studies enrolled healthy adult volunteers in the United States under fed and fasting conditions.
Two completed Phase 1 trials have evaluated Ziprasidone. NCT01581879 was a bioequivalence study of ziprasidone HCL capsules, 20 mg, under fed conditions, enrolling 38 healthy volunteers. NCT01581866 was a bioequivalence study of the same 20 mg capsules under fasting conditions, enrolling 56 healthy volunteers. Both were conducted in the United States.
Yes, ziprasidone hydrochloride is an alternative name for ziprasidone. The two names refer to the same drug asset developed by Dr. Reddy's Laboratories Ltd. The completed Phase 1 bioequivalence trials used ziprasidone HCL capsules at a 20 mg dose in healthy adult volunteers.