Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
Phase of Trial: Phase I
Latest Information Update: 10 Jan 2018
At a glance
- Drugs Testosterone undecanoate (Primary)
- Indications Hypogonadism
- Focus Pharmacokinetics; Registrational
- Acronyms DF
- Sponsors Lipocine
- 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.
- 10 Jan 2018 According to a Lipocine media release, the FDA decision on whether or not to approve the TLANDO New Drug Application (NDA) is anticipated by the assigned Prescription Drug User Fee Act (PDUFA) goal date of May 8, 2018.
- 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 (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.