Product Description
Marinus is developing Ganaxolone as a treatment for seizure disorders. (Sourced from: https://marinuspharma.com/pipeline/science-pipeline/about-ganaxolone/)
Mechanisms of Action: GABA Modulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intravenous
FDA Designation: Orphan Drug - Lennox Gastaut SyndromeOrphan Drug - Tuberous Sclerosis *
Approval Status: Approved
Approved Countries: United States
Approved Indications: Seizures
Known Adverse Events: Status Epilepticus | Suicidality | Drug Hypersensitivity | Environmental Hypersensitivity | Pregnancy Outcomes
Company: Marinus
Company Location: RADNOR PA 19087
Company CEO: Scott Braunstein
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Slovakia, Spain, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: CDKL5-deficiency Disorder|Epilepsy|Status Epilepticus|Tuberous Sclerosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
TrustTSC OLE | P3 |
Enrolling by invitation |
Epilepsy|Tuberous Sclerosis |
2027-06-01 |
86% |
1042-TSC-3002 | P3 |
Not yet recruiting |
Tuberous Sclerosis|Epilepsy |
2026-07-06 |
|
1042-CDD-3002 | P3 |
Not yet recruiting |
CDKL5-deficiency Disorder |
2024-12-01 |
86% |
RAISE | P3 |
Active, not recruiting |
Status Epilepticus |
2024-11-30 |
95% |