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Sarizotan - Newron Pharmaceuticals

Drug Profile

Sarizotan - Newron Pharmaceuticals

Alternative Names: EMD 128130

Latest Information Update: 22 Nov 2019

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At a glance

  • Originator Merck KGaA
  • Developer Merck KGaA; Newron Pharmaceuticals
  • Class Antiparkinsonians; Antipsychotics
  • Mechanism of Action Dopamine D2 receptor partial agonists; Serotonin 1A receptor agonists
  • Orphan Drug Status

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

    Yes - Rett syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II/III Rett syndrome
  • Discontinued Drug-induced dyskinesia

Most Recent Events

  • 21 Nov 2019 Sarizotan receives Rare Pediatric Disease designation from the US FDA for Rett Syndrome
  • 01 Feb 2019 Newron announces intention to submit NDA to the US, Canada and European regulatory agencies after Q4 2019
  • 01 Feb 2019 Newron Pharmaceuticals completes enrolment in the phase II/III STARS trial for Rett syndrome in the USA, India, United Kingdom, Australia and Italy (NCT02790034)
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