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

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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: 06 May 2025

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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

  • 01 May 2025 Results evaluating efficacy and tolerability of oral, twice-daily testosterone undecanoate [LPCN 1021] versus topical testosterone 1.62% gel [Androgel] as a testosterone replacement therapy in men with hypogonadism published in the Andrology.
  • 29 Mar 2022 According to a Lipocine media release, the U.S. Food and Drug Administration ("FDA") has approved TLANDO (testosterone undecanoate), in adult males with hypogonadism.
  • 03 Feb 2022 According to a Lipocine media release, the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO (testosterone undecanoate). The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act (PDUFA). Lipocine licensed the exclusive U.S. rights for TLANDO to Antares Pharma.

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