A 6-Month Safety Study of QuickShot Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Trial Profile

A 6-Month Safety Study of QuickShot Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2017

At a glance

  • Drugs Testosterone enanthate (Primary)
  • Indications Hypogonadism
  • Focus Adverse reactions; Registrational
  • Acronyms STEADY
  • Sponsors Antares Pharma
  • Most Recent Events

    • 21 Dec 2017 According to an Antares Pharma media release, the company announced that a written request for a Type A meeting, along with a comprehensive briefing document, have been submitted to the U.S. Food and Drug Administration (FDA), in response to the Complete Response Letter (CRL).
    • 20 Oct 2017 According to an Antares Pharma media release, the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for XYOSTED (testosterone enanthate) injection. The CRL indicates that the FDA cannot approve the NDA in its present form because the FDA is concerned that XYOSTED could cause a clinically meaningful increase in blood pressure and raised a concern regarding the occurrence of depression and suicidality.
    • 27 Feb 2017 According to an Antares Pharma media release, New Drug Application (NDA) for QuickShot Testosterone (QST), been accepted for standard review by the U.S Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017.
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