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Also known as ZYN002 - Cannabidiol Transdermal Gel
ZYN002- Cannabidiol · 2 trials · 1 indication
Safety assessment will include collection of any treatment emergent adverse events
The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 to 12, and a higher value indicates a worse outcome.
The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 and 12, and the higher score means a worse outcome.
| Arm | Type | Description |
|---|---|---|
| ZYN002 | EXPERIMENTAL | ZYN002 - cannabidiol Transdermal Gel |
| ZYN002 - Cannabidiol transdermal gel | EXPERIMENTAL | ZYN002 supplied as a transdermal gel. Patients weighing less than or equal to 35 kg will be randomized to receive either 125 mg cannabidiol Q12H or placebo. Patients weighing greater than 35 kg will be randomized to receive 250 mg cannabidiol Q12H or placebo. |
| Placebo transdermal gel | PLACEBO_COMPARATOR | Matching ZYN002 placebo supplied as a transdermal gel. |
| Name | Type | Description |
|---|---|---|
| ZYN002 - Cannabidiol Transdermal Gel | DRUG | Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery) |
| Placebo Transdermal Gel | OTHER | Placebo formulated as a clear gel (transdermal delivery) |
Inclusion Criteria: * Participated in study ZYN2-CL-016 or Study ZYN2-CL-033. * Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures. * Patients and parents/caregivers must be adequately informed of the nature, risks of the study, and give wr...
ZYN002 is a transdermal gel formulation of cannabidiol being developed for the treatment of Fragile X Syndrome, a rare genetic condition. It is currently in Phase 2 clinical development and is intended for use in children and adolescents aged 3 years and older.
ZYN002 contains cannabidiol, a small molecule that interacts with the endocannabinoid system. The drug is administered as a transdermal gel, allowing absorption through the skin. Its mechanism of action in Fragile X Syndrome is being studied in clinical trials.
ZYN002 is being developed by Harmony Biosciences Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRMY. The company is conducting clinical trials to evaluate the safety and efficacy of ZYN002 in patients with Fragile X Syndrome.
ZYN002 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been conducted or are ongoing, including a completed placebo-controlled study and an active open-label extension study.
ZYN002 has been studied in two clinical trials. The first, NCT03614663, is a completed Phase 2 study called CONNECT-FX, which evaluated the drug in 212 children and adolescents with Fragile X Syndrome. The second, NCT03802799, is an active open-label extension study assessing long-term safety in 476 participants.
Yes, ZYN002 is also known as ZYN002 Cannabidiol Transdermal Gel. The drug is a transdermal gel formulation of cannabidiol, and both names refer to the same investigational product being developed for Fragile X Syndrome.