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: 09 May 2018

At a glance

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

    • 09 May 2018 According to a Lipocine media release, the company announced that it has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for TLANDO. A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.
    • 10 Jan 2018 According to a Lipocine media release, Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
    • 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.
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