Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xywav · 1 trial · 2 indications
ESS is a self-administered questionnaire with 8 questions. Each question is scored on a scale ranging from 0 (would never fall asleep) to 3 (high chance of falling asleep). It has a total score ranging from 0 to 24, with a higher score representing increased daytime sleepiness.
| Arm | Type | Description |
|---|---|---|
| Narcolepsy Cohort once-nightly expanded Xywav dose group | ACTIVE_COMPARATOR | Participants with narcolepsy will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks. |
| Narcolepsy Cohort once-nightly expanded Xywav followed by placebo group | PLACEBO_COMPARATOR | Participants with narcolepsy will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks. |
| Narcolepsy Cohort twice-nightly expanded Xywav dose group | ACTIVE_COMPARATOR | Participants with narcolepsy will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks. |
| Narcolepsy Cohort twice-nightly expanded Xywav followed by placebo group | PLACEBO_COMPARATOR | Participants with narcolepsy will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks. |
| IH Cohort once-nightly expanded Xywav dose group | ACTIVE_COMPARATOR | Participants with IH will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks. |
| IH Cohort once-nightly expanded Xywav followed by placebo group | PLACEBO_COMPARATOR | Participants with IH will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks. |
| IH Cohort twice-nightly expanded Xywav dose group | ACTIVE_COMPARATOR | Participants with IH will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks. |
| IH Cohort twice-nightly expanded Xywav followed by placebo group | PLACEBO_COMPARATOR | Participants with IH will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks. |
| Name | Type | Description |
|---|---|---|
| Xywav | DRUG | 0.5 g/ml calcium, magnesium, potassium, and sodium oxybates solution taken by mouth |
| Placebo | OTHER | Placebo solution taken by mouth |
Inclusion Criteria: 1. Has a primary diagnosis of IH or narcolepsy Type 1 or Type 2 (NT1 or NT2) 2. Participants with a primary diagnosis of NT1 must have a history of at least 14 cataplexy attacks in a typical 2-week period, based on participant history at the time of diagnosis and prior to initia...
Xywav is an investigational small molecule being studied for the treatment of narcolepsy. It is currently in Phase 3 clinical development. The drug is being evaluated for its efficacy and safety in participants with narcolepsy or idiopathic hypersomnia.
The specific molecular target of Xywav is not disclosed in the available information. Therefore, the exact mechanism of action is not described here. The drug is being studied for its therapeutic effects in narcolepsy and idiopathic hypersomnia.
Xywav is being developed by Jazz Pharmaceuticals plc, a company listed on the stock exchange under the ticker JAZZ. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with narcolepsy.
Xywav is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting participants to assess its efficacy and safety.
Xywav is being studied in a Phase 3 clinical trial with the identifier NCT07625280. This randomized, double-blind, placebo-controlled trial is evaluating the efficacy and safety of Xywav expanded dosing versus placebo in participants with narcolepsy or idiopathic hypersomnia. The trial is recruiting in the United States.
Xywav is a distinct investigational drug being developed by Jazz Pharmaceuticals. It is not identified as being the same as any other named treatment in the available information. Its unique properties and mechanism are under investigation in clinical trials.