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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 oral capsules
Ziprasidone · 1 trial · 1 indication
YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
| Arm | Type | Description |
|---|---|---|
| Ziprasidone oral capsules | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ziprasidone oral capsules | DRUG | Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
| placebo oral capsules | DRUG | Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
Inclusion Criteria: * DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years Exclusion Criteria: * Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation
Top 10 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Xanomeline and trospium chloride, Xanomeline/Trospium Chloride |
| AbbVie, Inc. | ABBV | 3 | PHASE3 | Cariprazine, ABBV-932, Icalcaprant |
| Xenon Pharmaceuticals Inc. | XENE | 2 | PHASE3 | Azetukalner |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Rapport Therapeutics, Inc. | RAPP | 1 | PHASE2 | RAP-219 |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE2 | NBI-1117568 |
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-100 |
| LB Pharmaceuticals, Inc. | LBRX | 1 | PHASE2 | LB-102 |
| BioXcel Therapeutics, Inc. | BTAI | 1 | PHASE1 | BXCL501 |
| Alzamend Neuro, Inc. | ALZN | 1 | PHASE1 | AL001 |
Ziprasidone is being studied for the treatment of bipolar I disorder in children and adolescents, specifically for manic or mixed episodes. It is an investigational use in this pediatric population, evaluated in a Phase 3 clinical trial. Ziprasidone oral capsules are the formulation referenced for this development program.
Ziprasidone targets the serotonin 2A receptor (HTR2A), the dopamine D2 receptor (DRD2), and the serotonin 2C receptor (HTR2C). It acts as an antagonist at these receptors. This receptor binding profile is the basis for its activity in psychiatric conditions such as bipolar disorder.
Viatris Inc. (ticker: VTRS) is the developer of Ziprasidone for bipolar disorder. The company is associated with the clinical development program evaluating ziprasidone oral capsules in pediatric patients with bipolar I disorder.
Ziprasidone is in Phase 3 development for bipolar disorder. The program includes one completed Phase 3 trial. Ziprasidone is not approved for this pediatric bipolar disorder indication based on the available development information, and it remains an investigational use in this setting.
Ziprasidone has been studied in the Phase 3 trial NCT00257166, titled Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed). The trial was completed, enrolled 238 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.
Yes, Ziprasidone oral capsules is an alternative name for Ziprasidone. Both refer to the same small molecule drug. The oral capsule formulation is the one referenced in the clinical development program for bipolar disorder.