Drug Profile
Ganaxolone - Marinus Pharmaceuticals
Alternative Names: CCD-1042; Ganaxalone-IV; gnx; GNX oral suspension - Marinus Pharmaceuticals; ZTALMYLatest Information Update: 18 Apr 2024
Price :
$50
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At a glance
- Originator Purdue Pharma
- Developer Marinus Pharmaceuticals; Purdue Pharma; Tenacia Biotechnology
- Class Analgesics; Antidepressants; Antiepileptic drugs; Antimigraines; Anxiolytics; Ketones; Neuroprotectants; Pregnanes; Small molecules
- Mechanism of Action GABA A receptor modulators
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Marketed Early infantile epileptic encephalopathy 2
- Phase III Status epilepticus; Tuberous sclerosis
- Phase II Epilepsy; Fragile X syndrome
- Phase I Lennox-Gastaut syndrome
- Suspended Major depressive disorder; Postnatal depression
- No development reported Angelman syndrome
- Discontinued Infantile spasms; Migraine; Neuropathic pain; Partial epilepsies; Post-traumatic stress disorders
Most Recent Events
- 15 Apr 2024 Marinus Pharmaceuticals anticipates filing a supplemental New Drug Application to the US FDA in the first half of 2025 with a request for priority review
- 28 Mar 2024 Marinus Pharmaceuticals affirms its commitment to defending its patent portfolio amidst an Inter Partes Review (IPR) challenge of US patent from Ovid Therapeutics
- 19 Mar 2024 Marinus Pharmaceuticals plans a phase II trial for Encephalopathy in Q4 2024 (PO)