Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Clemizole HCl
Clemizole · 2 trials · 2 indications
Percent change in CMMS-28 from the Baseline Period through the end of the DB Period
Percent change in CMS-28 from the Baseline Period through the end of the DB period.
Percent change in CMS-28 from the Baseline Period through the end of the maintenance period.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive their first dose of study drug following randomization. |
| Double-blind clemizole HCl | EXPERIMENTAL | Participants will receive their first dose of study drug following randomization. |
| Open-label clemizole HCl | EXPERIMENTAL | Eligible participants who complete the DB Period will have the option to continue in the OLE Period, during which they will receive clemizole HCl for up to 3 years. |
| Name | Type | Description |
|---|---|---|
| Clemizole HCl | DRUG | Clemizole HCl will be administered as an oral solution. |
| Placebo | DRUG | Placebo will be administered as an oral solution. |
Key Inclusion Criteria: 1. Males or females, ages ≥2 to ≤55 years, at the time of Screening. 2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent. 3. Diagnosis of LGS, including: * Evidence of at least one type of countable major m...
Clemizole is an investigational small molecule being developed for the treatment of Dravet Syndrome and Lennox Gastaut Syndrome, both rare forms of epilepsy. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Clemizole targets the 5-HT2 receptor, a subtype of serotonin receptor. By modulating this target, the drug is being studied for its potential to reduce seizure frequency in patients with Dravet Syndrome and Lennox Gastaut Syndrome.
Clemizole is being developed by Harmony Biosciences Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRMY. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy.
Clemizole is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 3 trials are actively recruiting patients to assess its efficacy and safety.
Clemizole is being studied in two Phase 3 trials. NCT05066217 is evaluating the drug in patients with Lennox Gastaut Syndrome, enrolling 260 participants in the United States. NCT04462770 is studying Clemizole in Dravet Syndrome, with 150 participants across multiple countries including the US, Canada, and several European nations.
Yes, Clemizole HCl is the hydrochloride salt form of Clemizole. Clinical trials use the HCl formulation, and the terms are often used interchangeably when referring to the investigational drug being developed by Harmony Biosciences.