Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GWP42006 · 3 trials · 2 indications
The number of subjects who experienced an adverse event during each arm of the study is presented.
| Arm | Type | Description |
|---|---|---|
| GWP42006 | EXPERIMENTAL | GWP42006 |
| Placebo control | PLACEBO_COMPARATOR | Placebo |
| Group 1a | EXPERIMENTAL | Subjects on inducer AEDs will administer GWP42006. |
| Group 2a | ACTIVE_COMPARATOR | Subjects on inhibitor AEDs will administer GWP42006. |
| Group 3a | EXPERIMENTAL | Subjects on AEDs that are neither inducers nor inhibitors will administer GWP42006. |
| Group 1b | PLACEBO_COMPARATOR | Matching placebo control for Group 1a. |
| Group 2b | PLACEBO_COMPARATOR | Matching placebo control for Group 2a. |
| Group 3b | PLACEBO_COMPARATOR | Matching placebo control for Group 3a. |
| Group/dose level 1a | EXPERIMENTAL | 25 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 1b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 1a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 2a | EXPERIMENTAL | 75 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 2b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 2a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 3a | EXPERIMENTAL | 200 mg GWP42006 oral solution (single dose) followed by an intravenous administration of 5 mg GWP42006 after the oral dose |
| Group/dose level 3b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 3a |
| Group/dose level 4a | EXPERIMENTAL | 400 mg GWP42006 oral solution |
| Group/dose level 4b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 4a |
| GWP42006 1, 2, or 3 times daily | EXPERIMENTAL | Subjects will receive the selected dose of GWP42006 once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. |
| Placebo 1, 2, or 3 times daily | PLACEBO_COMPARATOR | Subjects will receive placebo once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. |
| Name | Type | Description |
|---|---|---|
| GWP42006 | DRUG | - |
| Placebo Control | DRUG | - |
| Placebo | DRUG | - |
For inclusion in Part B of the study patients must fulfil ALL of the following criteria: * Male or female aged between 18 and 65 years, inclusive. * Well-documented history of focal epilepsy, compatible electroencephalogram and clinical history. * Documented computerized tomography / magnetic reson...
GWP42006 is an investigational small molecule being developed for epilepsy, including focal seizures. It is a Phase 2 candidate studied in adults aged 18 years and older. The drug is not approved and remains in clinical development.
GWP42006 is being developed by Jazz Pharmaceuticals plc, a company traded on the NASDAQ under the ticker JAZZ. The drug is an investigational small molecule in Phase 2 development for epilepsy.
GWP42006 is in Phase 2 clinical development for epilepsy. It has completed three trials, including one Phase 1 study in healthy volunteers and two Phase 2 studies in people with focal seizures. The drug is investigational and not yet approved.
GWP42006 has completed three trials: NCT01918735, a Phase 1 safety and tolerability study in healthy subjects; NCT02365610, a Phase 2 study in people with focal seizures (Part B); and NCT02369471, a Phase 2 study in people with focal seizures (Part A). All trials are completed.
GWP42006 is a small molecule being studied for epilepsy. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not described here.
GWP42006 is not the same as Epidiolex. Epidiolex is a cannabidiol-based medicine, while GWP42006 is a separate investigational compound developed by Jazz Pharmaceuticals. GWP42006 is in Phase 2 trials for epilepsy and is not approved.