Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older ( 1 ) FDA label
Also known as JZP926 capsule, CBD-OS, GWP42003-P, Cannabidiol Oral Solution, Epidiolex, Epidyolex
JZP926 · 5 trials · 5 indications
Assess the reduction in spike wave index by evaluating the differences in activity from the four 24-hour ambulatory EEGs each participant obtains while enrolled in this study
| Arm | Type | Description |
|---|---|---|
| CBD-OS | EXPERIMENTAL | Participants with DEE will be randomized to CBD-OS up to 10 mg/kg twice daily for a 6-week treatment period. |
| Placebo | PLACEBO_COMPARATOR | Participants with DEE will be randomized to matching placebo for a 6-week treatment period. |
| Open-Label Extension: CBD-OS | EXPERIMENTAL | Participants with DEE who completed the double-blind phase of the study and enter the optional OLE will begin a 22-week open-label treatment period with CBD-OS up to 10 mg/kg twice daily following a 2-week Blinded Transition Period. |
| JZP926 Capsule | EXPERIMENTAL | Participants with JME will be randomized to JZP926 capsule based on weight-tiered dosing for a 16-week treatment period. |
| Open-Label Extension: JZP926 Capsule | EXPERIMENTAL | Participants completing Part A or Part B will have the option to continue into an open-label extension for up to 52 weeks, inclusive of a 4 week blinded transition. |
| Presymptomatic Epidiolex Treatment | EXPERIMENTAL | Epidiolex will be started at 2.5 mg/kg/day divided twice daily. The dose will increase weekly as tolerated over the next 5 weeks to a target dose of 20 mg/kg/day. |
| IP | ACTIVE_COMPARATOR | Epidiolex (Cannabidiol) is a colorless to yellow solution in a 100mL vial that is to be administered with a 5mL syringe.The starting dosage is 2.5 mg/kg twice daily, or 5 mg/kg/day. After one week, the dosage can be increased to a maintenance dosage of 5mg/kg twice daily, or 10 mg/kg/day. Patients who are tolerating Epidiolex at 10mg/kg per day and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance. Dosage of 10mg/kg twice daily (20mg/kg/day), in weekly increments of 2.5 mg/kg twice daily(5mg/kg/day), as tolerated. For patients in whom a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased to no more frequently than every other day administration of the 20 mg/kg/day. Dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions. |
| Name | Type | Description |
|---|---|---|
| CBD-OS | DRUG | Oral solution, twice daily |
| Placebo | DRUG | Oral solution, twice daily |
| JZP926 capsule | DRUG | Oral administration BID according to body weight |
| Epidiolex 100 mg/mL Oral Solution | DRUG | Epidiolex is a prescription form of cannabidiol used to treat seizures. Epidiolex will be started at 2.5 mg/kg/day divided twice daily. The dose will increase weekly as tolerated over the next 5 weeks to a target dose of 20 mg/kg/day. |
Participants are eligible to be included in the study only if all the following criteria apply: 1. Is at least 1 year of age at the time of signing the informed consent/assent. 2. Meets the clinical phenotype for DEE as specified in the protocol. 3. Per the investigator, the underlying etiology con...
JZP926 is an investigational small molecule being developed by Jazz Pharmaceuticals plc for the treatment of juvenile myoclonic epilepsy, a form of epilepsy that begins in childhood or adolescence. It is currently in Phase 2 clinical development and is not yet approved for any indication.
JZP926 is being studied for the treatment of juvenile myoclonic epilepsy. This is the only indication currently under investigation for the drug. It is an investigational therapy and has not been approved by the FDA for any use.
JZP926 is being developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker symbol JAZZ. Jazz Pharmaceuticals is the sponsor of the clinical program evaluating the drug in juvenile myoclonic epilepsy.
JZP926 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial is currently recruiting participants and has not yet been completed.
JZP926 is being evaluated in a single Phase 2 trial, NCT07723963, titled A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy. The trial is recruiting, is placebo-controlled and double-blind, and plans to enroll 260 participants in the United States.
Yes, JZP926 capsule is another name for JZP926. The capsule designation refers to the oral capsule formulation of the drug being evaluated in the Phase 2 trial for juvenile myoclonic epilepsy. Both names refer to the same investigational asset developed by Jazz Pharmaceuticals.