Testosterone undecanoate oral twice-daily - Lipocine

Drug Profile

Testosterone undecanoate oral twice-daily - Lipocine

Alternative Names: ABT-SLV361; LPCN-1021; TLANDO

Latest Information Update: 13 Aug 2018

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At a glance

  • Originator Lipocine
  • Class Anabolic steroids; Androstenols; Hormonal replacements; Small molecules; Testosterone congeners
  • Mechanism of Action Androgen receptor agonists; Testosterone replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Hypogonadism

Most Recent Events

  • 07 Jun 2018 Lipocine initiates the ambulatory blood pressure (ABPM study) safety trial of TLANDO™
  • 09 May 2018 Lipocine receives complete response letter from the US FDA for testosterone undecanoate for Hypogonadism
  • 10 Jan 2018 The Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of US FDA votes against benefit/risk profile of testosterone undecanoate for Hypogonadism
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