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Also known as Quetiapine, oral formulation, Quetiapine, Quetiapine XR
Quetiapine, formulation · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 003 | PLACEBO_COMPARATOR | Placebo Daily for 3 weeks |
| 002 | ACTIVE_COMPARATOR | Quetiapine 400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks |
| 001 | EXPERIMENTAL | Paliperidone ER 3 to 12 mg daily, flexibly dosed, for 12 weeks |
| Cohort A: Aripiprazole | EXPERIMENTAL | - |
| Cohort B: Quetiapine | EXPERIMENTAL | - |
| Cohort C: Olanzapine | EXPERIMENTAL | - |
| Cohort D: Risperidone | EXPERIMENTAL | - |
| Cohort E: Paliperidone | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Daily for 3 weeks |
| Quetiapine | DRUG | 400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks |
| Paliperidone ER | DRUG | 3 to 12 mg daily, flexibly dosed, for 12 weeks |
| Aripiprazole | DRUG | Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast. |
| Olanzapine | DRUG | Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast. |
| Risperidone | DRUG | Type= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast. |
| Paliperidone | DRUG | Type= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast. |
Inclusion Criteria: * Meets Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM IV) criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features) * history of at least 1 previously documented manic or mixed episode requiring medical t...
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 |
Quetiapine is an oral antipsychotic medicine studied and used in psychiatry, including for bipolar disorder. In the clinical program described here it was evaluated in patients with bipolar I disorder and mood disorders, and separately in healthy volunteers for blood concentration comparisons. It is available in immediate-release and extended-release oral formulations, including a 50 mg extended-release strength.
Quetiapine 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 underlies its activity as a small-molecule antipsychotic agent used in psychiatric conditions such as bipolar disorder.
Quetiapine is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is associated with the oral quetiapine formulations, including immediate-release quetiapine and the extended-release version known as quetiapine XR, which is also available in a 50 mg strength.
Quetiapine has been studied in Phase 3 clinical development for bipolar disorder. The Phase 3 trial in this program is completed, and no trials are currently active. A separate Phase 1 study in healthy volunteers has also been completed. Quetiapine is an established oral small-molecule antipsychotic available in immediate-release and extended-release formulations.
Quetiapine has been evaluated in two completed trials. NCT00309699 was a Phase 3, randomized, double-blind, placebo-controlled study of flexible-dose extended-release paliperidone compared with flexible-dose quetiapine and placebo in 493 patients with bipolar I disorder across multiple countries. NCT01607762 was a Phase 1 study comparing capillary and venous whole blood and plasma concentrations of five antipsychotics in 31 healthy volunteers in Belgium.
Quetiapine XR is an extended-release oral formulation of quetiapine, so the two names refer to related forms of the same medicine rather than different drugs. Quetiapine XR is also available in a 50 mg strength. Other names used for this asset include quetiapine oral formulation and quetiapine XR 50 mg.