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Midazolam intranasal - Proximagen

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Drug Profile

Midazolam intranasal - Proximagen

Alternative Names: ITI-111; Midazolam Nasal Spray - Proximagen; NAYZILAM CIV; USL-261

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Intranasal Therapeutics
  • Developer Ikano Therapeutics; Proximagen; UCB
  • Class 3-ring heterocyclic compounds; Antiepileptic drugs; Benzodiazepines; Chlorinated hydrocarbons; Fluorobenzenes; Hypnosedatives; Imidazoles; Sleep disorder therapies; 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 - Seizures
  • New Molecular Entity No

Highest Development Phases

  • Marketed Seizures
  • No development reported Epilepsy
  • Discontinued Anaesthesia; Anxiety disorders; Mild cognitive impairment

Most Recent Events

  • 10 Apr 2021 Efficacy results from the phase III ARTEMIS2 open label extension trial in Epilepsy presented at the 73rd Annual Meeting of the American Academy of Neurology (AAAN-2021)
  • 05 Dec 2019 Launched for Seizures (In adolescents, In adults) in USA (Intranasal)
  • 28 Nov 2019 No recent reports of development identified for phase-I development in Epilepsy(In children) in Unknown (Intranasal, Spray)

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