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A 12-week, randomized, double-blind, placebo-controlled Phase III study of evenamide

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Trial Profile

A 12-week, randomized, double-blind, placebo-controlled Phase III study of evenamide

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 16 May 2025

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At a glance

  • Drugs Evenamide (Primary)
  • Indications Schizophrenia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENIGMA-TRS 2
  • Sponsors Newron Pharmaceuticals

Most Recent Events

  • 16 May 2025 New trial record
  • 12 May 2025 According to a Newron Pharmaceuticals media release, company will receive up to a maximum total of EUR 117 million, including an upfront payment of EUR 44 million, financial contributions to the Phase III ENIGMA-TRS program, milestone payments, and tiered royalties up to a double-digit percentage of net sales for evenamide, from EA Pharma; Myung In Pharm will contribute 10% of the total patient population to be enrolled into upcoming Phase III ENIGMA-TRS trial and cover the costs related.
  • 12 May 2025 According to a Newron Pharmaceuticals media release, trial approved by the US Food and Drug Administration (FDA), will be performed at centers in the US and selected additional countries.US investigational centers are expected to initiate the study within the next three months.

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