Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
Phase of Trial: Phase I
Latest Information Update: 14 Aug 2017
At a glance
- Drugs Testosterone undecanoate (Primary)
- Indications Hypogonadism
- Focus Pharmacokinetics
- Acronyms DV
- Sponsors Lipocine
- 14 Aug 2017 According to a Lipocine media release, the US FDA has acknowledged receipt of the Company's NDA resubmission and has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of February 8, 2018.
- 09 Aug 2017 According to a Lipocine media release, based on the data from this study and integrated safety set (ISS) from all previously conducted clinical trials including SOAR study (see profile 225746), 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.
- 19 Jun 2017 Results from this trial published in a Lipocine Media Release.