Approval Probability
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Also known as PRAX-628, vormatrogine
Vormatrigine · 2 trials · 5 indications
Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs
Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628
| Arm | Type | Description |
|---|---|---|
| Open-label 30 mg/day vormatrogine for up to 2 years | EXPERIMENTAL | Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years. |
| Open-label 30mg/day PRAX-628 for 8 weeks | EXPERIMENTAL | Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks. |
| Name | Type | Description |
|---|---|---|
| vormatrogine | DRUG | Once daily oral |
| 30mg PRAX-628 | DRUG | Once daily oral |
Inclusion Criteria: * Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded acces...
Vormatrigine is an investigational small molecule being developed for epilepsy, specifically tonic-clonic seizures and focal onset seizures. It is a Phase 3 candidate from Praxis Precision Medicines, Inc. and has not been approved by any regulatory agency. It is being studied in adults aged 18 years and older.
Vormatrigine is being studied to treat epilepsy, including tonic-clonic seizures and focal onset seizures. Clinical trials also include primary generalized seizures. It is an investigational therapy and is not approved for any indication. The Phase 3 program is enrolling adults with these seizure types across multiple countries.
Vormatrigine targets sodium channels, which are ion channels that regulate electrical signaling in neurons. By acting on sodium channels, the drug is designed to reduce abnormal neuronal firing that leads to seizures. This ion channel mechanism is the basis for its development in epilepsy.
Vormatrigine is being developed by Praxis Precision Medicines, Inc., which trades on the Nasdaq under the ticker PRAX. The company is the sponsor of the clinical program evaluating the drug in epilepsy. Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on therapies for central nervous system disorders.
Vormatrigine is in Phase 3 clinical development. The Phase 3 trial NCT07287163 is enrolling by invitation and plans to enroll 700 adults with epilepsy. A Phase 2 open-label trial, NCT06908356, is also recruiting. Vormatrigine is investigational and has not received FDA approval.
Vormatrigine is being evaluated in two registered clinical trials. NCT07287163 is a Phase 3 trial in adult patients with epilepsy, including tonic-clonic and focal seizures, enrolling 700 participants across the United States, Brazil, Germany, Italy, Poland, and Spain. NCT06908356 is a Phase 2 open-label trial in adults with focal onset or tonic-clonic seizures, recruiting 50 participants in the United States, Australia, and Spain.
Yes, Vormatrigine is also known as PRAX-628. Other names used for the same investigational compound include vormatrogine and 30mg PRAX-628. These refer to the same sodium channel targeting small molecule being developed by Praxis Precision Medicines for epilepsy, so searches for PRAX-628 and Vormatrigine describe the same drug candidate.