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Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men

Trial Profile

Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 May 2019

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At a glance

  • Drugs Testosterone undecanoate (Primary) ; Testosterone
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • Acronyms SOAR
  • Sponsors Lipocine
  • Most Recent Events

    • 14 May 2019 According to a Lipocine media release, the U.S. Food and Drug Administration (FDA) has accepted its 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 Prescription Drug User Fee Act (PDUFA) goal date of Nov 9, 2019.
    • 07 Nov 2018 According to a Lipocine media release, the company expects to re-submit the TLANDO NDA in the first half of 2019.
    • 31 Aug 2018 Biomarkers information updated
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