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olanzapine pamoate depot · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Olanzapine Pamoate Depot | EXPERIMENTAL | Olanzapine pamoate depot |
| Olanzapine | ACTIVE_COMPARATOR | Oral olanzapine |
| Name | Type | Description |
|---|---|---|
| olanzapine | DRUG | 10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks. |
| olanzapine pamoate depot | DRUG | 405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks. |
Inclusion Criteria: * Clinical diagnosis of schizophrenia * Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks. * Disease symptoms must meet a certain range as assessed by the clinician. * Patient has experienced at least two episodes of clinical worsening o...
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Olanzapine pamoate depot is an injectable long-acting formulation of olanzapine being developed for the treatment of schizophrenia. It is designed to provide sustained antipsychotic coverage after administration, which may support treatment adherence in patients who require long-term therapy. It is given by intramuscular injection.
Olanzapine pamoate depot targets dopamine receptors DRD2, DRD3, and DRD4, and serotonin receptors HTR2A and HTR2C. It acts as an antagonist at these receptors. This receptor binding profile underlies its antipsychotic activity in schizophrenia.
Olanzapine pamoate depot is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Eli Lilly is the sponsor of the clinical program for this long-acting injectable antipsychotic.
Olanzapine pamoate depot is in Phase 3 clinical development for schizophrenia. It is an investigational product and has not been approved by the FDA. The Phase 3 program includes one completed trial, and no trials are currently active.
Olanzapine pamoate depot has been studied in a completed Phase 3 trial, NCT00320489, titled Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia. The trial enrolled 524 participants across the United States, Argentina, Brazil, Canada, France, Greece, Portugal, Puerto Rico, Romania, Slovakia, Spain, and Taiwan.
The Phase 3 trial NCT00320489 was a randomized, active-controlled study comparing olanzapine pamoate depot with oral olanzapine in adult outpatients with schizophrenia. It enrolled 524 participants aged 18 years and older and was completed. The study was not double-blind.