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Drug Profile

Ganaxolone - Marinus Pharmaceuticals

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

Latest Information Update: 20 Feb 2025

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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
  • 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; Tuberous sclerosis

Most Recent Events

  • 11 Feb 2025 Marinus Pharmaceuticals has been acquired by Immedica
  • 30 Dec 2024 Orion Corporation and Marinus Pharmaceuticals mutually terminate their European wide marketing and distribution agreement for ganaxolone in Europe
  • 29 Oct 2024 Marinus Pharmaceuticals discontinues a phase III TrustTSC OLE trial for Tuberous sclerosis (Adjunctive treatment, In children, In adults, In adolescents, in the elderly) in Belgium, Canada, France, Germany, Israel, Italy, Spain and the United Kingdom (PO, Suspension) (NCT05604170)

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