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Evenamide - Newron Pharmaceuticals

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Drug Profile

Evenamide - Newron Pharmaceuticals

Alternative Names: EA-8001; NW-3509; NW-3509A

Latest Information Update: 07 Jul 2026

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At a glance

  • Originator Newron Pharmaceuticals
  • Developer EA Pharma; Newron Pharmaceuticals
  • Class Antidepressants; Antiepileptic drugs; Antimanics; Antipsychotics; Non-opioid analgesics; Small molecules
  • Mechanism of Action Dopamine D2 receptor agonists; Dopamine D2 receptor antagonists; Nav1.3 voltage-gated sodium channel inhibitors; NAV1.7 voltage gated sodium channel expression inhibitors; Nav1.7 voltage-gated sodium channel inhibitors; NAV1.8 voltage gated sodium channel expression inhibitors; Nav1.8 voltage-gated sodium channel inhibitors; Serotonin 5-HT2 receptor agonists; Serotonin 5-HT2 receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Schizophrenia
  • Phase II/III Psychiatric disorders

Most Recent Events

  • 02 Jul 2026 Newron Pharmaceuticals held a Type A meeting with the US FDA to consider re-start of enrollment in the phase III ENIGMA-TRS 2 trial in Schizophrenia in USA
  • 29 Apr 2026 The US FDA places a hold on the enrolment of new patients in the US sites of phase III ENIGMA-TRS 2 trial in Schizophrenia (NCT07184619)
  • 14 Apr 2026 Phase-III clinical trials in Schizophrenia (Adjunctive treatment, Treatment-resistant) in France (PO) (CTIS2024-519836-18-00)

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