Midazolam intranasal - Proximagen

Drug Profile

Midazolam intranasal - Proximagen

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

Latest Information Update: 16 Aug 2018

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At a glance

  • Originator Intranasal Therapeutics
  • Developer Ikano Therapeutics; Proximagen
  • Class Antiepileptic drugs; Benzodiazepines; Hypnosedatives; 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

  • Preregistration Seizures
  • Phase I Epilepsy
  • Discontinued Anaesthesia; Anxiety disorders; Mild cognitive impairment

Most Recent Events

  • 13 Aug 2018 The US FDA accepts NDA for midazolam intranasal for Seizures for review
  • 01 May 2018 Preregistration for Seizures (In adolescents, In adults) in USA (Intranasal)
  • 20 Apr 2018 Proximagen announces intention to submit 505(b) NDA to US FDA for Seizures in 018 based on the results of its phase III ARTEMIS1 trial (93845)
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