Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.

Trial Profile

Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.

Completed
Phase of Trial: Phase I

Latest Information Update: 17 Nov 2017

At a glance

  • Drugs Testosterone undecanoate (Primary)
  • Indications Hypogonadism
  • Focus Pharmacokinetics
  • Acronyms DV
  • Sponsors Lipocine
  • Most Recent Events

    • 17 Nov 2017 According to a Lipocine media release, the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for TLANDO for the proposed indication of testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of May 8, 2018.
    • 18 Oct 2017 According to a Lipocine media release, the U.S. Food and Drug Administration has scheduled the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) meeting on January 10, 2018 to discuss the New Drug Application (NDA) for TLANDO, for the proposed indication of testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
    • 14 Aug 2017 According to a Lipocine media release, the US FDA has acknowledged receipt of the Company's NDA resubmission and has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of February 8, 2018.
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