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

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2017

At a glance

  • Drugs Testosterone undecanoate (Primary) ; Testosterone
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • Acronyms SOAR
  • 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.
    • 09 Aug 2017 According to a Lipocine media release, based on the data from dosing validation study (see profile 280522) and integrated safety set (ISS) from all previously conducted clinical trials including SOAR study, the company has resubmitted a New Drug Application (NDA) for LPCN 1021 for testosterone replacement therapy (TRT) in adult males for hypogonadism. Six-month review by the FDA and PDUFA date expected in the first quarter of 2018.
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