Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Midazolam intranasal - Proximagen

Drug Profile

Midazolam intranasal - Proximagen

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

Latest Information Update: 31 Jan 2019

Price : $50 *
* Final gross price and currency may vary according to local VAT and billing address.
* Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. A link to download a PDF version of the drug profile will be included in your email receipt. Adis is an information provider. We do not sell or distribute the pharmaceutical compounds written about in this database.

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)
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top