Testosterone undecanoate oral twice-daily - Lipocine

Drug Profile

Testosterone undecanoate oral twice-daily - Lipocine

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

Latest Information Update: 05 Sep 2017

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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

  • 17 Aug 2017 US FDA accepts resubmitted NDA for Hypogonadism for review
  • 17 Aug 2017 Lipocine completes its dosing flexibility trial for Hypogonadism (NCT03242408)
  • 16 Aug 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Hypogonadism in USA (PO) is 2018-02-08
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