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Ganaxolone - Marinus Pharmaceuticals

Drug Profile

Ganaxolone - Marinus Pharmaceuticals

Alternative Names: CCD-1042; Ganaxalone-IV; gnx; GNX oral suspension - Marinus Pharmaceuticals; ZTALMY

Latest Information Update: 21 Jun 2024

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Status epilepticus; Fragile X syndrome; Epilepsy; Early infantile epileptic encephalopathy 2; Infantile spasms; Tuberous sclerosis; Lennox-Gastaut syndrome
  • 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

  • 17 Jun 2024 Marinus Pharmaceuticals plans to engage with the US FDA to discuss a potential path forward for ganaxolone in Status epilepticus
  • 17 Jun 2024 Efficacy and adverse events data from a phase III trial in Status Epilepticus released by Marinus Pharmaceuticals
  • 17 May 2024 Marinus Pharmaceuticals has patent protection for ganaxolone in the treatment of tuberous sclerosis complex (TSC) in the US
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