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Diazepam intranasal - Neurelis

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Drug Profile

Diazepam intranasal - Neurelis

Alternative Names: diazepam nasal spray; NRL-01; NRL-1; VALTOCO; VALTOCO-nasal-spray

Latest Information Update: 26 May 2025

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At a glance

  • Originator Neurelis
  • Developer Aculys Pharma; China Medical System; Neurelis
  • Class Antiepileptic drugs; Anxiolytics; Benzodiazepines; Benzodiazepinones; Hypnosedatives; Muscle relaxants; Small molecules
  • Mechanism of Action GABA A receptor agonists
  • Orphan Drug Status

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

    Yes - Epilepsy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Epilepsy

Most Recent Events

  • 28 Apr 2025 Neurelis completes a phase I/II trial for Epilepsy (In children) in USA (Intranasal,Spray) (NCT05076838)
  • 16 Apr 2025 Neurelis submits sNDA to the US FDA for Epilepsy (In children) in USA, prior to April 2025
  • 16 Apr 2025 US FDA approves Diazepam intranasal for Epilepsy (In children) in USA

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