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?

A Phase III, placebo-controlled, pivotal trial of AM-111 (0.4 mg/mL) in patients suffering from acute profound hearing loss

Next Previous
Trial Profile

A Phase III, placebo-controlled, pivotal trial of AM-111 (0.4 mg/mL) in patients suffering from acute profound hearing loss

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2022

Price : $35 *
  • Adis is an information provider.
  • 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 trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Brimapitide (Primary)
  • Indications Sensorineural hearing loss
  • Focus Therapeutic Use

    • Most Recent Events

    • 12 Sep 2018 New trial record
    • 30 Aug 2018 According to an Auris Medical media release, the company had a Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA has provided guidance regarding the endpoints, design of the trial, the planned sample size, statistical methodology and the regulatory path forward. This trial design also incorporates specific feedback provided by the European Medicines Agency (EMA) earlier this year.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top